FDA News

FOR IMMEDIATE RELEASE
P04-01

January 8, 2004

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FDA Provides Pathway for Sponsors Seeking Approval of Breast Implants

The Food and Drug Administration (FDA) today revised its guidance
document for breast implant sponsors to more clearly define FDA?s
recommendations for breast implant marketing applications and to reflect
the availability of new information about the framework for assessing
the safety and effectiveness of these products. The draft guidance
document has been released for public comment and is available at

http://www.fda.gov/cdrh/ode/guidance/1239.html.

?The FDA, sponsors, and the clinical community have learned a great deal
about breast implants, especially silicone gel-filled breast implants,
over the last 10 years,? said Mark B. McClellan, M.D. Ph.D.,
Commissioner of Food and Drugs.

?Based on this knowledge, this revised guidance is our view on the
information needed to provide a reasonable assurance of safety, and to
allow women and physicians to make informed decisions about silicone
implants.?

?FDA is committed to working with sponsors and the scientific community
to provide a clear, scientifically appropriate, and up-to-date pathway
for demonstrating safety and effectiveness, and we welcome comments on
this draft guidance,? Commissioner McClellan said.

This guidance document updates a previous version published in February
2003. The previous version of the guidance document has been useful to
sponsors and FDA in preparing and reviewing pre-market approval (PMA)
applications. By updating its guidance document, FDA is more clearly
identifying the type and amount of scientific data that will allow FDA
to evaluate whether these products are safe and effective.

The substantive new recommendations in the draft guidance document
involve mechanical testing, modes and causes of rupture, clinical study
information, postapproval requirements, and labeling.

The new recommendations are as follows:

      MECHANICAL TESTING

The General Information section has been modified to recommend that the
mechanical testing be designed so that it can predict clinical outcomes,
such as how long breast implants will last before rupturing in the body.

The Fatigue Rupture Testing of Total Device section has been modified
because the methods currently used do not appear to simulate the
observed rates of rupture. FDA is now recommending that a sponsor
develop a new test methodology that can accurately predict rates of
rupture over time. As stated in the guidance document, FDA believes that
retrieval study data, which accurately define the mode(s) and cause(s)
of rupture, may be helpful in the design of the new test methodology.

The Bleed Testing section has been modified, updating the previous
section called Bleed Rates of Silicone Gel or Alternative Filler. FDA
now recommends that a sponsor develop a new gel bleed test that more
closely mimics conditions in the body to identify and quantify the
chemicals that bleed (leach) out of the shell over time. This
information will help FDA in evaluating the safety of these products,
and will help provide adequate information to women who might be
considering breast implants.

MODES AND CAUSES OF RUPTURE

A new section, Modes and Causes of Rupture, has been added to the
guidance document, updating the previous section called Retrieval Study.
The new section clarifies FDA's recommendation that a sponsor
characterize the modes and causes of rupture. These data will help
predict how rupture rates change over time and help allow an adequate
assessment of the safety of the product.

In the guidance document, FDA recommends that modes and causes of
rupture be addressed by the following:

? a retrieval study involving examination and testing of breast implants
that have been removed from patients

? an assessment of a sponsor?s manufacturing processes for the shell to
determine whether any allowances for imperfections, such as bubbles and
contaminants, may be related to device rupture

? an assessment of the surgical techniques that increase the risk of
rupture to better guide doctors on the best way to implant these devices

? a comprehensive literature review of durability based on studies of
explanted devices.

CLINICAL STUDIES

The General Information section has been modified to clarify that,
although a sponsor may submit a PMA with a minimum of two years of
clinical data, this data may not be sufficient to demonstrate a
reasonable assurance of safety and effectiveness. FDA may recommend the
submission of additional premarket data to describe the rates of
complications (e.g., rupture and re-operation), to reasonably predict
the safety profile of the device over its lifetime, and to address
safety concerns, such as the risk of gel migration for silicone
gel-filled breast implants. For example, if, after two years, a sponsor
does not have a sufficient number of patients, sufficient follow-up, or
appropriate analyses to reliably predict the rupture rate and the
clinical consequences of rupture over time, additional clinical
follow-up may be recommended to allow an adequate assessment of the
safety and effectiveness of the device.

A new subsection, titled Rupture of Silicone Gel-Filled Breast Implants,
has been added to the guidance document, updating the previous
subsection called Silent Rupture for Silicone Gel-Filled Breast
Implants. The revised section focuses on rupture as a whole, not just
silent rupture, and includes new recommendations for data collection.
FDA now recommends that a sponsor provide the following data as part of
its Core Study:

? the rate and rate of change of rupture over the expected lifetime of
the device

? the frequency of ruptures observed (intracapsular, extracapsular, and
migrated gel). For all patients with ruptured implants undergoing
explantation, FDA recommends that a sponsor provide tissue sampling data
of the surrounding breast tissue and capsule to confirm whether or not
gel implant constituents are present.

? characterization of any local health consequences of ruptured
implants.

The guidance document recommends that the duration of follow-up and the
follow-up rates of the subset of patients undergoing MRI screening for
rupture (i.e., MRI cohort) should be adequate to define the silent
rupture rate and, accordingly, the overall rupture rate.

The Connective Tissue Diseases (CTDs) subsection has been modified to
clarify our recommendations regarding data collection on CTDs and CTD
signs and symptoms. FDA recognizes that much has been learned over the
last decade on this issue, including data and analysis from the 1999
Institute of Medicine (IOM) report on the safety of silicone breast
implants, and that the Core Study is not designed to examine a potential
linkage between breast implants and the development of CTDs. We do,
however, recommend that a sponsor collect information on diagnoses of
CTD as part of the overall safety assessment on its device.

A new section, titled Supplemental Clinical Information, has been added
to the guidance document. Because of the limited size of a Core Study,
FDA recommends that a sponsor provide additional clinical information on
its device (e.g., retrospective or prospective data from adjunct and/or
European studies), as well as relevant information from the published
literature, to address the following issues related to implant rupture:

? the frequency of observed intracapsular gel, extracapsular gel, and
migrated gel, as well as the destination of the migrated gel

? a detailed description of the local health consequences experienced by
all patients with ruptured implants, including the severity of these
consequences, and their clinical course

? the incidence, prevalence, and timing of silent ruptures that progress
to symptomatic ruptures

? the incidence, prevalence, and timing of intracapsular ruptures that
progress to extracapsular ruptures.

The section titled Supplemental Literature Information, has been
modified. FDA continues to recommend that a sponsor provide a
supplemental literature review on specific topics such as CTDs
(including fibromyalgia), mammography issues, neurological disease,
ability to lactate, and offspring issues (safety of milk for
breastfeeding and second generation effects). However, in this updated
guidance document, FDA now specifies that it recommends a current
literature review beginning with the 1999 IOM report and explains that
the purpose of this information is to provide up-to-date information for
women who might be considering breast implants.

The Postapproval Requirements section has been modified to clarify that
FDA may exercise its statutory authority to require sponsor compliance
with conditions of approval or other postapproval requirements, such as:

? a Core postapproval study. For silicone gel-filled breast implants,
FDA believes that annual physician follow-up, rather than mail-in survey
follow-up, may be appropriate, primarily because some important
complications, such as silent rupture, cannot be assessed by the patient

? continued collection of bench data regarding modes and causes of
rupture

? an education and certification program to train doctors with regard to
proper surgical technique, patient selection, patient monitoring, and

? management of complications in order to obtain access to the implant
? continuation or initiation of a registry.

LABELING

The Physician Labeling and Patient Labeling sections have been modified
to recommend that a sponsor include information in the labeling for
breast implants on the following:

? method(s) and frequency of screening for rupture

? clinical management of suspicious intracapsular and extracapsular
rupture

? gel bleed results

? other supplemental information based on a current literature review.

The recommendations in the guidance document will assist sponsors in
providing adequate information to allow FDA to assess whether the data
demonstrate a reasonable assurance of safety and effectiveness of breast
implants. This information will allow women and physicians to make
informed decisions regarding the use of these products.
####

Draft Guidance Document (PDF)

Federal Register Notice of Availiability of
Guidance Document

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Saline, Silicone Gel, and Alternative Breast Implants
   
DRAFT GUIDANCE

This guidance document is being
distributed for comment purposes only.
Document issued on: January 13, 2004
Comments and suggestions regarding this draft document should be
submitted within 90 days of publication in the Federal Register of the
notice announcing the availability of the draft guidance. Submit written
comments to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

Alternatively, electronic comments may be submitted to

http://www.fda.gov/dockets/ecomments.

All comments should be identified with the docket number listed in the
notice of availability that publishes in the Federal Register.

For questions regarding this document contact Ms. Samie Allen at
301-519-370, ext.139 or by email at sxn@....

When final, this document will supersede ?Guidance for Saline, Silicone
Gel, and Alternative Breast Implants? dated February 11, 2003.

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
Plastic and Reconstructive Surgery Devices Branch
Division of General, Restorative, and Neurological Devices
Office of Device Evaluation
Contains Nonbinding Recommendations
Draft - Not for Implementation
Preface
Additional Copies
Additional copies are available from the Internet at
http://www.fda.gov/cdrh/ode/guidance/1239.pdf or you may either send a
fax request to (301) 443-8818 to receive a hard copy of the document, or
send an e-mail request to gwa@... to request hard or electronic
copy. Please use the document number (1239) to identify the guidance you
are requesting.

Table of Contents

1. INTRODUCTION
2. BACKGROUND
2.1 Saline-Filled Breast Implant
2.2 Silicone Gel-Filled Breast Implant
2.3 Alternative Breast Implant
3. DEVICE DESCRIPTION
4. CHEMISTRY
4.1 General Information
4.2 Extent of Crosslinking
4.3 Extractables
4.4 Volatiles
4.5 Heavy Metals
4.6 Saline Filler
4.7 Silicone Gel Filler
4.8 Alternative Filler - Polymer
4.9 Alternative Filler ? Non-Polymer
5. TOXICOLOGY
5.1 General Information
5.2 Pharmacokinetic Studies
5.3 Toxicological Testing
5.4 Special Considerations
6. MECHANICAL TESTING
6.1 General Information
6.2 Fatigue Rupture Testing of Total Device
6.3 Valve Competency Testing
6.4 Cohesivity Testing
Cohesivity of Silicone Gel-Filled Breast Implants
Cohesivity of Alternative Breast Implants
6.5 Bleed Testing
Bleed of Silicone Gel-Filled Breast Implants
Bleed of Alternative Breast Implants
6.6 Stability Testing of Alternative Breast Implants
7. MODES AND CAUSES OF RUPTURE
Retrieval Study
8. SHELF LIFE TESTING
9. CLINICAL STUDIES
9.1 General Information
9.2 Clinical Study Design/Statistical Analyses
Sample Size
Lost-to-Follow-Up Analyses
9.3 Safety Assessment
Complications
Rupture of Silicone Gel-Filled Breast Implants
Rupture of Alternative Breast Implants
Connective Tissue Diseases (CTDs)
9.4 Effectiveness Assessment
Anatomical Effect
Health Related Quality of Life (HRQL)
Satisfaction
9.5 Supplemental Clinical Information
Silicone Gel-Filled Breast Implants
Alternative Breast Implants
9.6 Supplemental Literature Information
9.7 Postapproval Requirements
10. CLINICAL DATA PRESENTATION
10.1 General Information
10.2 Patient Accounting Presentation
10.3 Demographics and Baseline Characteristics
10.4 Safety Data Presentation - Complications
Overall Sum of Complications
Cumulative Incidence of Complications
Kaplan-Meier Analyses of Complications
Reasons for Device Removal
Reasons for Reoperation
Types of Additional Surgical Procedures
Kaplan-Meier Analyses of Complications Occurring After Device Removal
With Replacement
10.5 Safety Data Presentation ? Rupture
10.6 Safety Data Presentation - CTDs
CTD Diagnoses
CTD Signs/Symptoms Categories
CTD Signs/Symptoms
10.7 Safety Data Presentation - Mammography Data
10.8 Effectiveness Data Presentation
Anatomical Effect
HRQL
Patient Satisfaction
10.9 Pooling Analyses
10.10 Additional Analyses
Logistic Regression Analyses of Each Safety and Effectiveness Outcome
Cox Proportional Hazards Regression Analyses of Rupture/Deflation
11. LABELING
11.1 General Information
11.2 Package Labels
11.3 Physician Labeling
11.4 Patient Labeling
11.5 Patient Device Card
Draft Guidance for Industry and FDA Staff
Saline, Silicone Gel, and Alternative Breast Implants
This draft guidance, when finalized, will represent the Food and Drug
Administration's (FDA's) current thinking on this topic. It does not
create or confer any rights for or on any person and does not operate to
bind FDA or the public. You can use an alternative approach if the
approach satisfies the requirements of the applicable statutes and
regulations. If you want to discuss an alternative approach, contact the
FDA staff responsible for implementing this guidance. If you cannot
identify the appropriate FDA staff, call the appropriate number listed
on the title page of this guidance.
1. Introduction
This guidance document, when final, will identify device description,
preclinical, clinical, and labeling information that we recommend be
presented in a premarket approval (PMA) application. This guidance
document may also be useful in the preparation of a product development
protocol (PDP), an application for an investigational device exemption
(IDE), a reclassification petition, or a master access file (MAF). The
information discussed pertains to breast implants filled with saline,
silicone gel, or alternative filler intended for breast augmentation,
breast reconstruction, and/or revision. This guidance document does not
address tissue expanders, which are reviewed under the premarket
notification (510(k)) process.
This version of the guidance document updates the information described
in ?Guidance for Saline, Silicone Gel, and Alternative Breast Implants?
dated February 11, 2003. The 2003 version of this guidance document has
proved useful to both sponsors and FDA in preparing and reviewing PMAs
for saline-filled breast implants. FDA, sponsors, and the clinical
community have learned a great deal about silicone gel-filled breast
implants over the last 10 years. Accordingly, this version of the
guidance document reflects the latest thinking in science and medicine
pertaining to breast implants. The primary changes are to the Mechanical
Testing, Modes and Causes of Rupture (which replaces the previous
Retrieval Study section), Clinical Studies, and Labeling sections.
This guidance document supplements other FDA publications on PMA, PDP,
and IDE applications and should not be construed as a replacement for
these documents. For general information about these applications, see
CDRH?s Device Advice website as follows: PMAs (21 CFR Part 814),
http://www.fda.gov/cdrh/devadvice/pma/; PDPs (21 CFR § 814.19),
http://www.fda.gov/cdrh/devadvice/pma/app_methods.html; and IDEs (21 CFR
Part 812), http://www.fda.gov/cdrh/devadvice/ide/index.shtml. Sponsors
are responsible for developing clinical protocols and providing
reasonable assurance of the safety and effectiveness of their devices.
FDA's guidance documents, including this guidance document, do not
establish legally enforceable responsibilities. Instead, guidance
documents describe the Agency's current thinking on a topic and should
be viewed only as recommendations, unless specific regulatory or
statutory requirements are cited. The use of the word should in Agency
guidance documents means that something is suggested or recommended, but
not required.
2. Background
There are three types of breast implants, all of which may be intended
for breast augmentation, breast reconstruction, and revision.
2.1 Saline-Filled Breast Implant
A saline-filled breast implant has a silicone rubber shell made of
polysiloxane(s), such as polydimethylsiloxane and polydiphenylsiloxane,
which is inflated to the desired size with sterile isotonic saline.
Saline-filled breast implants may vary in shell surface, shape, profile,
volume, and shell thickness. Most have valves that self-seal and a patch
that covers the manufacturing port. The sterile saline used as a filler
material should conform to United States Pharmacopeia (USP) standards
for Normal Physiological Saline (injection grade), which has a
concentration of 0.15M and a pH of 7.2-7.4.
There are three types of saline-filled breast implants. One type is a
fixed volume implant with a single lumen that is intraoperatively filled
with the entire volume of saline via a valve. A second type is an
adjustable volume implant with a single lumen that is intraoperatively
filled with saline via a valve and has the potential for further
postoperative adjustment of the saline. A third type is a prefilled
saline implant.
In the Federal Register of June 24, 1988 (53 FR 23856), FDA issued a
final rule classifying the silicone inflatable (saline-filled) breast
prosthesis into Class III (21 CFR § 878.3530). On January 6, 1989 (54
FR 550), FDA published a notice of intent to require submission of PMAs
for these devices. On January 8, 1993 (58 FR 3436), FDA issued a
proposed rule to require submission of PMAs or completion of PDPs. On
August 19, 1999 (64 FR 45155), FDA issued a final rule requiring PMAs
for these devices to be filed with FDA, or PDPs to be completed, within
90 days. Thus, an approved PMA or PDP is now required to market a
saline-filled breast implant.
2.2 Silicone Gel-Filled Breast Implant
A silicone gel-filled breast implant has a silicone rubber shell made of
polysiloxane(s), such as polydimethylsiloxane and polydiphenylsiloxane,
which is filled with a fixed amount of silicone gel. Silicone gel-filled
breast implants may vary in shell surface, shape, profile, volume, and
shell thickness. Most have a patch that covers the manufacturing port.
There are three types of silicone gel-filled breast implants. One type
is a fixed volume implant with a single lumen containing a fixed amount
of silicone gel. A second type is an inflatable double lumen implant
with the inner lumen containing a fixed amount of silicone gel and the
outer lumen designed with a valve for filling with saline
intraoperatively. A third type is an inflatable double lumen implant
with the outer lumen containing a fixed amount of silicone gel and the
inner lumen designed with a valve for filling with saline
intraoperatively, with the potential for postoperative adjustment.
In the Federal Register of June 24, 1988 (53 FR 23856), FDA issued a
final rule classifying the silicone gel-filled breast prosthesis into
class III (21 CFR § 878.3540). On January 6, 1989 (54 FR 550), FDA
published a notice of intent to require submission of PMAs for these
devices. On May 17, 1990 (55 FR 20568), FDA issued a proposed rule to
require submission of PMAs or completion of PDPs. On April 10, 1991 (56
FR 14620), FDA issued a final rule requiring PMAs for these devices to
be filed with FDA, or PDPs to be completed, within 90 days. Thus, an
approved PMA or PDP is now required to market a silicone gel-filled
breast implant.
2.3 Alternative Breast Implant
An alternative breast implant typically has a silicone rubber shell with
a filler other than saline or silicone gel. The filler material may or
may not be a gel. However, an alternative breast implant may also have
an alternative shell other than one made from silicone rubber. We may
recommend alternative or additional evaluations of alternative breast
implants depending on their design, materials, and performance
characteristics.
All alternative breast implants are class III post-amendment devices
that require an approved PMA or PDP for marketing. (Federal Food, Drug,
and Cosmetic Act (FDCA) §§ 513(f) & 515(a) (21 U.S.C. §§ 360c(f)
& 360e(a)).)
3. Device Description
The Background section above (Section 2) provides a very basic device
description for each of the three types of breast implants. This section
recommends the type of device description information you should include
in your application. However, depending on the particular design of your
device, additional information may be appropriate.
We recommend that you provide the following device description
information (if applicable):
a written description of each component that comprises the device (e.g.,
shell, gel, patch, textured surface, valve)
the specific materials (with suppliers) for each component
a description of any connector systems, fill tubes, and injection domes,
including materials
a magnified sketch of each style of device, depicting the placement/use
of the connector systems, fill tubes, and injection domes
a description of when the device is filled by the surgeon if not a
prefilled device (i.e., intraoperatively and/or postoperatively)
a description of any overexpansion/overfill of the filler material, even
if on a temporary basis
a description of the method by which the device is sterilized
a summary table of all devices under review in the submission (see
example table below):
StyleShell
SurfaceShape,
ProfileVolume
(cc) Width
(cm)Height
(cm)Projection
(cm)Shell Thickness
(mm)XXXXSmoothRound,
High125-6509-168.4-153.1-5.70.015?-0.040?        
Depending on the specific design features of your device, we may
recommend that you include additional information in your summary table.
For example, if there is overexpansion of your device or your device has
a combination saline/silicone gel design, you should include a column to
capture pertinent information.
4. Chemistry
4.1 General Information
We recommend that you provide the following general information
regarding the chemicals/materials used in the manufacture of your breast
implant:
the common names and trade names of each chemical/material (including
additives, plasticizers, and antioxidants)
the specific role of each chemical/material in the manufacturing process
and/or in the final device
the location of the material within the device (e.g., shell, filler,
valve, adhesive)
the chemical name, the mean molecular weight, and a measure of the
polydispersity for each polymeric component
material safety data sheets for each chemical
MAF numbers for each material, including specific volume and page number
references.
We also recommend that you state whether the silica used in the
elastomer shell dispersion is in the amorphous form or the crystalline
form.
Sections 4.2 through 4.5 of this document describe chemical analyses of
the elastomer shell (including the patch and valve) that we recommend
you describe in your submission. Sections 4.6 through 4.9 describe
chemical analyses of the filler material. Additional analyses may be
appropriate due to changes in design features, such as texturing,
variations of device components, such as patches or valves, or changes
in sterilization.
4.2 Extent of Crosslinking
The manufacture of the shell involves curing of polymeric components of
silicones by chemical crosslinking. We recommend that you provide the
extent of crosslinking from at least three different lots to confirm the
uniformity of the degree of crosslinking across lots. Suggested methods
to determine the extent of crosslinking include:
measurement of Young?s modulus at low strain (this is approximately
proportional to crosslink density)
measurement of equilibrium swelling of the polymeric component by a good
solvent
determination of the amount of unreacted crosslinker from the total
extractables
any other acceptable scientific method.
We recommend that you also perform a Fourier Transform Infrared
Spectroscopy (FTIR) analysis on the cured polymer to confirm the
presence of silicone functional groups.
4.3 Extractables
We recommend that you conduct an analysis of the extractable or
releasable chemicals to identify potentially toxic chemicals and
estimate the upper limits of the chemicals that could be released into
the patient. Although other methods may be used, the following is one
suggested method for obtaining extractable data:
Perform the extraction of the shell for chemical analyses with at least
one polar solvent (i.e., ethanol or a mixture of ethanol-water) and two
non-polar solvents (i.e., dichloromethane and hexane) at 37°C. To
determine the duration of the exhaustive extractions, you should conduct
a series of successive extractions by exposing the sample to the solvent
for a period of time, analyzing the solvent for extractables, replacing
with fresh solvent, exposing the sample again for a period of time,
analyzing, and repeating the process.
When the level of the analyte for the extraction is one-tenth (0.1) the
level in the previous extraction, the extraction is deemed complete so
that a 10% correction to the total extractable material can be applied.
In cases where this condition may not occur because of extremely slow
migration of the higher molecular weight material, you should apply the
test to the contents of the extract with molecular weights of ?1500
Daltons because these are the compounds of greatest interest. You should
add all separate analyte levels to calculate the cumulative value and,
via the sample/solvent ratio, the sample and device levels. You should
use the total extraction from the polar solvent and the extraction from
one of the non-polar solvents that yields the higher amounts of
extractables for both quantitative and qualitative analyses. For
extracts that may contain oligomeric or polymeric species, you should
provide the molecular weight distribution, along with the number and
weight average molecular weights and the polydispersity. You should
perform an FTIR analysis on the extractable residuals.
We recommend that you provide the following information from your
analyses of the extractables:
identification and quantification of all compounds below a molecular
weight of 1500 Daltons after exhaustive extraction of the final
sterilized shell. These should include, but need not be limited to:
- residual monomers, cyclic and linear oligo-siloxanes
- known toxic residues such as polychlorinated biphenyls (PCBs), if
peroxide curing process is involved
- aromatic amines, if polyurethanes are used
the percent recovery, especially for the polydimethylsiloxanes (up to
D20)
evidence that shows that exhaustive extraction has been achieved with
one of the solvents
identification of all experimental methodology1
raw data (including instrument reports) with all chromatograms,
spectrograms, etc. You should also provide the practical quantitative
limit when the analyte of interest is not detected.2
1For example: Gel Permeable Chromatography (GPC), Gas Liquid
Chromatography (GLC), Mass Spectometry (MS), Atomic Emission Detector
(AED), and FTIR.
2Keith, L. Compilation of EPA's Sampling and Analysis Methods. Lewis
Publishers, 1992.
4.4 Volatiles
We recommend that you analyze the elastomer shell for volatile
components using a headspace detector.
4.5 Heavy Metals
We recommend that you provide qualitative and quantitative analyses for
heavy metals on the final finished shell. The heavy metal analyses
should include, but need not be limited to, analyses of the following
metals: platinum (Pt); tin (Sn); zinc (Zn); chromium (Cr); arsenic (As);
lead (Pb); antimony (Sb); nickel (Ni); and copper (Cu). In addition, for
the metal used as the catalyst in the curing reaction, we recommend that
you provide the valence state and the amount of residue of the catalyst.
In lieu of providing a complete heavy metal analysis on the finished
shell, you may provide the purity of the catalyst (with trace elements)
used in the raw shell material, along with an analysis of the finished
shell for just the catalyst metal used.
4.6 Saline Filler
Normal physiological sterile saline has a long history of use in breast
implants and is standardized by the USP. As stated above, the sterile
saline used with your device should conform to USP standards for Normal
Physiological Saline (injection grade), which has a concentration of
0.15M and a pH of 7.2-7.4. If your breast implant is used with any other
saline, we recommend that you provide a complete chemical analysis of
that saline.
4.7 Silicone Gel Filler
The analyses of the silicone gel should be very similar to those for the
elastomer shell. We recommend that you provide the following information
on the final sterilized gel:
qualitative and quantitative analyses for extractables (such as cyclic
polysiloxanes), including:
- characterization of the polymers present
- molecular weight averages and polydispersities of the polymers
- identification and quantification of all compounds present with a
molecular weight of ?1500 Daltons
qualitative and quantitative analyses for volatiles
qualitative and quantitative analyses for heavy metal contents
all physical properties of the gel, including viscosity, cohesivity, and
approximate crosslink density (if possible)
the percentage of silicone oil and its chemical and physical properties
(e.g., molecular weight, viscosity).
4.8 Alternative Filler - Polymer
We recommend that you provide the following information on a final
sterilized polymer filler:
the rationale for the use of the specific alternative filler material
a list of all the components used in the synthesis and the method of
synthesis of any polymer used in the preparation of filler (if it is a
synthetic polymer) or the source and isolation procedure of the polymer,
if it is a natural polymer
quantitative analyses of monomers (if synthetic polymer) and their
safety profiles
the method of purification of the polymer
complete physical and chemical characteristics of the polymer (e.g.,
viscosity, molecular weight)
the formulation of the polymer (the ratio of polymer should be specified
if the filler material is a mixture of more than one component)
the structural analyses of the polymer, including molecular weight
distribution
quantification and identification of all chemicals below a molecular
weight of 1500 Daltons and their characterization
the trace metal/heavy metal analysis and the valence state if metals
were used as catalysts in the polymerization reaction
the crosslink density (if it is a synthetic and cured material).
4.9 Alternative Filler ? Non-Polymer
We recommend that you provide the following information on a final
sterilized non-polymer filler:
the rationale for the use of the specific alternative filler material
composition of the non-polymer, including characterization of smaller
molecular weight components
the method of purification of the non-polymer
complete physical and chemical characteristics of the non-polymer (e.g.,
viscosity, molecular weight)
the source and isolation procedure of the non-polymer
the structural analyses of the non-polymer, including molecular weight
distribution.
5. Toxicology
5.1 General Information
A toxicological assessment should be conducted because breast implants
contain not only the major polymeric materials (e.g., polymerized
polydimethylsiloxane), but also low molecular weight components, such as
monomers, oligomers, catalysts, and residues from the manufacturing or
sterilization processes that may leach out into the patient?s body. The
toxicological safety assessment should be based on information from:
the chemical composition of the device (Section 4.1 above)
pharmacokinetic studies
the standard battery of toxicological tests.
The portion of your submission dealing with chemical composition should
provide a list of the chemicals present (Section 4.1 above).
Pharmacokinetic studies determine the rates of absorption, distribution,
metabolism, and elimination of the substances absorbed into the
patient?s body (Section 5.2). The standard toxicological testing battery
is used to detect unidentified toxins and to quantify the exposure to
known toxic compounds (Section 5.3).
5.2 Pharmacokinetic Studies
Knowledge of the pharmacokinetic behavior of potentially toxic chemicals
provides a scientific assessment of the potential of the chemicals to
accumulate in the body at concentrations that cause human health risks.
The pharmacokinetic study design you choose should be based on the
information needed to address the worst case assumption (i.e., that all
of the material in the device is absorbed into the body at once). If
this assumption, with the addition of safety factors, results in toxic
levels of exposure, demonstrations of slow diffusion of substances from
the device into the body or rapid metabolism or excretion of the
substances by the patient may negate the worst case assumption. The
pharmacokinetic testing of toxins of concern should determine the rates
of absorption into and clearance from the blood, the distribution in the
body, and the rates of metabolism and/or excretion. If radiolabeling is
used, the device should be labeled in ways that will reflect the fates
of all of the components of interest. For additional information, see
International Organization for Standardization (ISO) standard 10993-16.
5.3 Toxicological Testing
We recommend that you perform the standard battery of toxicological
tests separately on both the final sterilized shell and filler. These
tests include:
cytotoxicity
short and intermediate-term implantation tests
acute systemic toxicity
hemocompatibility
immunotoxicity
reproductive toxicity
teratogenicity
genotoxicity
carcinogenicity (including subchronic and chronic toxicity testing).
Refer to ISO-10993, ?Biological Evaluation of Medical Devices ? Part 1:
Evaluation and Testing,? and the CDRH guidance document, ?Use of
International Standard ISO-10993, 'Biological Evaluation of Medical
Devices Part 1: Evaluation and Testing',? available at
http://www.fda.gov/cdrh/g951.html, for more details about the
toxicological tests above.
Refer to Section 5.4 below for special considerations regarding some of
the toxicological tests.
5.4 Special Considerations
We recommend that you assess the level of immunotoxicity of the shell
and any leachable compounds from the shell and the gel (if applicable).
For more information, you should refer to the CDRH ?Immunotoxicity
Testing Guidance,? available at
http://www.fda.gov/cdrh/ost/ostggp/immunotox.pdf.
Reproductive and teratogenicity studies should measure the rates of
conception, as well as the number of fetal deaths and malformations. The
studies should include at least two generations. You should test
individual compounds at the highest possible exposure that does not
produce non-reproductive systemic toxicity.
Genotoxicity testing addresses the potential of leachable compounds
and/or degradation products of your device to cause cancer. FDA believes
that genotoxicity testing may be sufficient in lieu of 2-year
carcinogenicity testing if all of the short-term genotoxicity tests are
negative. The short-term genotoxicity testing should consist of, but
need not be limited to:
a bacterial mutagenicity test (including point mutations and frameshift
mutations)
a mammalian forward mutation assay (e.g., a mouse lymphoma test)
an in-vivo rodent micronucleus test.
However, even if the short-term genotoxicity testing is negative, FDA
may recommend 2-year carcinogenicity testing if (1) your device consists
of other materials than those typically present in
polydimethylsiloxane-based breast implants or (2) your device consists
of material compounds (e.g., D4) at higher-than-expected levels.
You may combine the carcinogenicity study with the subchronic and
chronic toxicity testing by removing animals from the carcinogenicity
study at appropriate intervals. In this case, the carcinogenicity study
should be initiated with additional animals to compensate for the
animals scheduled to be removed. If, however, a subchronic or chronic
toxicity emerges during the study, this may interfere with the ongoing
carcinogenicity study.
We recommend that you provide subchronic and chronic toxicity testing
because the leaching process may be slow, even when the material is in
pulverized form, exposing the animals or cells to very small quantities
of potential leachable toxicants or carcinogens. Implanted material may
also degrade over time, producing toxic degradation products. These
toxins might be detected only by subchronic or chronic implantation
tests. The subchronic implantation test reports should include gross and
histopathology examinations of the tissue surrounding the implanted
material and at appropriate sites remote from the implantation site with
gross lesions or potential connections to the observed toxicity.
If the short-term genetic toxicology testing is negative and the
clinical carcinogenic experience with the materials continues to support
safety, you may consider completing the carcinogenicity testing
concurrently with your ongoing Core Study.
6. Mechanical Testing
6.1 General Information
In general, we recommend that you design mechanical testing to be
predictive of clinical modes and causes of failure during the expected
life of your device. For example, whenever possible and applicable, the
test methodologies should mimic in-vivo conditions (e.g., incubate the
breast implants in a lipid-rich medium prior to testing and conduct
testing in a physiologic environment).
We suggest that you perform individual component and total device
testing to evaluate the mechanical properties of your breast implant.
These tests are described in Sections 6.2-6.6 below.
We recommend that you perform all testing on finished, sterilized total
devices or components (e.g., shell, gel, valve). If your device is
sterilized by different methods (e.g., ethylene oxide, gamma radiation),
we request that you perform the testing on samples sterilized by the
different methods, or provide an adequate rationale why the change in
sterilization method does not negatively impact the mechanical
characteristics.
We also request that you provide complete reports for all testing,
including identification of the devices tested and a description of the
test set-up and methods, including sketches or photographs.
With regard to material properties, such as tensile strength, ultimate
elongation, joint testing, and tear resistance, FDA believes that these
can be adequately addressed through your validation and verification
manufacturing activities.
6.2 Fatigue Rupture Testing of Total Device
Most materials have a finite fatigue life when repeatedly stressed
in-vivo. Repeated stressing of the device may eventually weaken the
shell and lead to failure.
When designing your fatigue testing protocol, FDA recommends that you
carefully consider the test methodology, such as the loading
direction(s) on the device, the shape of the loading apparatus that
contacts the devices, the testing medium, etc. We have found that the
current test methodology, in which flat plates compress the device in
air, is not predictive of clinical failure. More specifically, results
of testing using this method show that breast implants should not
rupture even at loads much greater than those expected in-vivo. However,
because current clinical information indicates that devices do rupture,
even at early timepoints, the validity of this test methodology is
questionable. A test methodology that replicates clinical failure
mode(s) should approximate the rate of rupture during the expected life
of your device. FDA believes that retrieval study data, which accurately
define the mode(s) and cause(s) of rupture, may be helpful in the design
of the new test methodology.
Therefore, we recommend that you provide a complete test report of
fatigue testing on the worst case, final, sterilized device(s) with the
thinnest shells allowed by the design release criteria using a test
set-up with particular focus on the loading direction(s) on the device,
the shape of the loading apparatus that contacts the device, the testing
medium, etc., that mimics expected in-vivo loading.
Fatigue testing should be performed in a constant load or a constant
displacement mode. However, you should perform constant displacement
testing only if you measure the actual applied loads continuously or at
frequent points during the testing and the variation of the actual
applied load is minimal. You should use the minimal load applied during
constant displacement testing to establish the endurance load level.
You should cyclically load the samples to runout or failure at varying
loads or displacements to generate an applied force versus number of
cycles (AF/N) curve for the worst case device(s). You should base the
runout value on the expected in-vivo cycles that the device will be
subjected to in its lifetime, and you should provide an adequate
rationale for the runout value.
You should test a minimum of 3 samples at a given load or displacement
from static point down to the endurance load level because of the
general variance seen in elastomer testing. You should start with the
static point and keep reducing the load or displacement for each
subsequent test until a sample can reach runout without failure. Whether
load or displacement control testing is performed, you should provide an
AF/N curve for each style of device tested. These curves may be
generated by best-fit approach or by averaging the number of samples
tested to establish a given point. There should be a tight range (e.g.,
10%) of points around and at the endurance load level for a cleaner
curve.
We recommend that you provide the following results for each style of
device tested:
the resulting endurance load level
the clinical relevance for the resulting endurance load level, including
the incorporation of a safety factor
the AF/N curve
the raw data
- applied loads
- applied displacements (only for displacement control test)
- corresponding number of cycles to failure (unless runout reached)
- sample thicknesses.
6.3 Valve Competency Testing
This testing pertains only to breast implants with valves. Valve
competence tests are performed to demonstrate that valve integrity is
maintained at in-vivo loads. Devices can be subjected to hydrostatic
forces that tend to force fluid out of the device, causing a deflation
and change in size and shape. The most likely source for increased
pressure inside the devices would be from patients reclining with
various body parts (e.g., head, arm, trunk) pressing on their devices.
ASTM standard F2051 states that there shall be no leakage observable
after a normally closed valve is subjected to a retrograde pressure
equivalent to 30cm H2O for 5 minutes and then to a retrograde pressure
equivalent to 3cm H2O for 5 minutes. FDA does not believe that the ASTM
F2051 methodology is clinically relevant with respect to the load
levels. However, this methodology may provide useful information about
the valve handling shifts in pressure. Therefore, you should provide a
complete report of valve competency testing as per ASTM F2051. You
should also provide the pass/fail results for leakage.
In addition to the testing above, you should provide a complete report
of destructive testing to address in-vivo loading conditions. You should
gradually load the samples until valve failure occurs to define a
maximum pressure for the device. We recommend that you provide the
following results:
the burst pressures
the failure modes (including whether the failed test valves reseal upon
removal of the excess failure-inducing pressures)
the rationale why the resulting burst pressures are clinically relevant.
6.4 Cohesivity Testing
This testing pertains only to silicone gel-filled and alternative breast
implants.
Cohesivity of Silicone Gel-Filled Breast Implants
We recommend that you quantify the cohesivity of the silicone gel.
Although the two methods described in ASTM F703 were not developed to
address gels with high cohesivities, the results provide useful device
characterization information. We recommend that you provide the complete
reports of the following testing to address gel cohesivity:
gel cohesion testing on the final device as described in the
cone/pendant method in ASTM F703
penetration testing (an indirect measure of gel cohesivity) on the
in-process gel.
For the gel cohesion testing, we recommend that you provide the
pass/fail results.
For the penetration testing, we recommend that you provide a complete
description of the penetration test method, the acceptance criteria, and
the results.
Cohesivity of Alternative Breast Implants
Depending on the filler of your alternative breast implant, FDA may
recommend that you provide cohesivity testing similar to that described
above for silicone gel-filled breast implants.
6.5 Bleed Testing
This testing pertains only to silicone gel-filled and alternative breast
implants.
Bleed of Silicone Gel-Filled Breast Implants
Silicone gel bleed is the diffusion of gel constituents (e.g., low
molecular weight silicones) through an intact shell. Although current
designs of breast implants should minimize gel bleed, gel bleed appears
to occur continuously for silicone gel-filled breast implants.
The ASTM F703 test methodology quantifies the extent of gel bleed.
However, the results from this testing would have limited clinical
correlation because the ASTM F703 test method was established for the
purpose of allowing comparison between device models rather than
quantifying in-vivo gel bleed. In addition, the ASTM F703 test method
was not established to identify and quantify the gel bleed constituents.
Thus, FDA does not believe that this test methodology provides adequate
data to address gel bleed for the purposes of a PMA.
Accordingly, we recommend that you provide a complete report of gel
bleed bench testing based on a protocol that mimics in-vivo conditions
(e.g., incubate the breast devices in a lipid-rich medium prior to
testing and conduct testing in a physiologic environment). We recommend
that you identity the gel bleed constituents (including the platinum
species (or other catalysts)), the rate that these gel constituents
bleed out, and how that rate changes over time.
Bleed of Alternative Breast Implants
For devices with alternative fillers, FDA is interested in potential
changes in composition of the alternative filler resulting from
long-term chronic bleed, for which there is little known information.
Therefore, we recommend that, in addition to performing the testing
described above for a silicone gel-filled breast implant, you provide
the results of a chemical analysis of the material remaining in the
device.
6.6 Stability Testing of Alternative Breast Implants
For a breast implant with an alternative polymer or non-polymer filler,
we recommend that you provide a complete report of long-term stability
and accelerated aging testing to demonstrate the effects of time and
temperature on the physical properties and chemical composition of the
device as a whole and of the filler material. You should measure key
physical parameters of the filler, such as viscosity and cohesivity, at
each timepoint. If there are mechanical changes, you should conduct
complete chemical analyses to explain the physical changes.
7. Modes and Causes of Rupture
The modes and causes of rupture should be characterized so that both the
rate of rupture and the rate of change of rupture over time can be
minimized to establish reasonable assurance of device safety.
Therefore, we recommend that you provide the following to characterize
the modes and causes of clinical rupture of your device:
a retrieval study of your explanted devices (see Retrieval Study section
below for more details)
an assessment of your manufacturing processes related to release
specifications of your shell to determine whether any allowances for
imperfections, such as bubbles and contaminants, may be related to
device rupture
an assessment of the surgical techniques that increase the risk of
rupture.
In addition, we recommend that you provide a comprehensive literature
review of durability studies based on explanted devices.
This information should aid in the design of preclinical tests that
predict the long-term rupture rate, encourage the design of improved
devices, and establish new tests for manufacturing acceptance criteria
for components or processes that contribute to device failure.
Retrieval Study
A retrieval study is intended to collect and to evaluate explanted
devices. We recommend that you design your retrieval study to ensure
that you will be able to successfully assess the modes and causes of
rupture. The literature reports numerous factors to consider when
evaluating the modes and causes of failure. Some of these factors are
directly related to the breast implant or its use, while others are not.
We recommend that you address the factors listed below in the design of
your retrieval study. The factors should include, but need not be
limited to:
device type/model
device size
device shell thickness
device surface (smooth versus textured)
device lot (lot-to-lot variability in initial gel and shell crosslinking
and mechanical properties)
length of implantation
device handling prior to insertion
device position
implantation technique (scalpel nicks, suture punctures, surgeon?s
finger imprints, clamp grip marks)
in-vivo material property and chemistry changes/degradation
in-vivo cyclic stress
in-vivo trauma (accident, mammography)
procedures performed while device is in-situ (biopsies, cyst
aspirations)
explantation technique.
A standard retrieval study should involve:
data collection at the time of explantation by the surgeon or
appropriate healthcare provider
laboratory testing of the explanted devices by you or a third party.
FDA recommends the article by Brandon, et al.3 for a description of the
type of information to consider during the development of your retrieval
study protocol (e.g., control group of unimplanted devices, detailed
chemical analyses of materials, detailed mechanical testing, scanning
electron microscopy, and analysis of local tissue/capsule).
3Brandon, et. al, ?Protocol for Retrieval and Analysis of Breast
Implants.? Journal of Long-Term Effects of Medical Implants, 13(1):
49-61. 2003.
8. Shelf Life Testing
We recommend that you provide both real-time mechanical testing and
packaging testing to establish the shelf life (i.e., expiration date)
for the device.
We recommend that you perform mechanical testing on representative aged
samples at time zero and at various intervals throughout the claimed
shelf life. The mechanical tests should include, but need not be limited
to:
ultimate elongation
joint
tensile set
break force
valve competency (if applicable)
gel cohesivity (if applicable).
With regard to packaging testing, we recommend that you test the final
finished package for initial integrity and maintenance of integrity
after selecting the appropriate materials and qualifying the package
configuration. You should use test methods that are either validated or
standardized. Below is a more detailed description of what we recommend
you provide to address initial package integrity and maintenance of
package integrity.
Initial Package Integrity
We recommend that you test the integrity of the seal and the whole
package at time zero. This includes both seal and whole package testing.
You should test the seals of the package for seal integrity and seal
strength. Seal integrity may be established by demonstrating that the
seal is impermeable and continuous. There are several standardized
methods that may be used to determine seal integrity. For example, ASTM
F1929 is a dye penetration method for detecting seal leaks. Seal
strength should demonstrate that the fiber shedding, splitting, and
tearing of the package is within your specifications.
For whole package testing, you may use physical or microbiological test
methods. Examples of whole package integrity tests are internal pressure
test, dye penetration, gas sensing test, or vacuum leak test. At the
present time, there are only a few standardized physical whole package
test methods. ASTM D3078 is an example of a test method by bubble
emission. Alternatively, you may use a microbial challenge test.
Maintenance of Package Integrity
We recommend that you evaluate the ability of the package to maintain
its integrity over time by the same functional tests used for integrity
testing. You should expose the package, with the device in it, to the
environmental stresses imposed by manufacturing, sterilization
processes, distribution, handling, vibration, and the storage
environment. You should perform the seal integrity and whole package
testing after stressing and at various intervals throughout the claimed
shelf life of the package. The data obtained during this time period
should remain within the validated limits of the performance
specification.
9. Clinical Studies
9.1 General Information
FDA requests that the Core Study (i.e., the primary IDE study used to
support PMA approval) involve 10 years or more of prospective patient
follow-up, including some premarket and some postmarket follow-up. The
extent of premarket follow-up data (clinical and preclinical) should be
sufficient to address specific safety concerns, such as the rates of
complications (e.g., rupture, reoperation) and their potential health
consequences, and to reasonably predict the safety profile of the device
over its lifetime. Depending on the data, 2 years of premarket clinical
data may not be sufficient to evaluate the safety and effectiveness of
your device, whether it is a saline-filled, silicone gel-filled, or
alternative breast implant. For example, because of the difficulty in
detecting rupture and the risk of extracapsular and migrated silicone
gel, additional years of premarket follow-up may be recommended for
silicone gel-filled breast implants.
We recommend that studies include the separate patient cohorts of
primary augmentation, primary reconstruction, and revision. Because
these studies are complicated by the fact that some patients receive
devices for different reasons (e.g., a woman may receive one device for
reconstruction and one for augmentation), we also recommend that you
record and analyze the data on both per patient and per device bases. We
recommend that you classify the patient and device by the initial
indication at study entry as follows:
If a reconstruction patient undergoes contralateral augmentation, that
patient would be classified as reconstruction. The device would be
classified as one reconstruction and one augmentation.
If a revision patient (i.e., the patient entered the study due to
replacement of an existing device, regardless of the type or
manufacturer of the original device), undergoes contralateral
augmentation, that patient would be classified as a revision patient.
The device would be classified as one revision and one augmentation.
Even if a revision (removal with replacement) occurs during the study
(i.e., after initial implantation), the patient and device would
continue to be classified based on the original indication (i.e.,
primary augmentation, primary reconstruction, or revision).
If patients undergo removal and replacement with your device, FDA
recommends that you continue follow-up of these patients. For patients
who undergo removal without replacement, or removal with replacement
with another manufacturer?s device, FDA still encourages you to continue
follow-up evaluations.
Refer to Section 10 for FDA's recommendations regarding the clinical
data presentations that you should provide for breast implants.
9.2 Clinical Study Design/Statistical Analyses
Clinical Study Design
We recommend that you provide a complete description of your Core Study.
This includes:
study objectives
primary and ancillary hypotheses
definitions of the study population (i.e., inclusion and exclusion
criteria)
methods of randomization, if applicable
number and locations of investigational sites
enrollment procedures
description of surgical techniques
description of allowable ancillary surgical interventions and/or drugs
description of chemotherapy, radiation, or other cancer treatments on
all reconstruction patients and on augmentation and reconstruction
patients who develop breast cancer during the course of the study (these
treatments can impact the development of local complications with
devices and, thus, impact the evaluation of the safety and effectiveness
of the device)
description of the control group (see paragraph below).
If you choose to incorporate a concurrent control group, we recommend
that you select an approved saline-filled breast implant. If you choose
not to incorporate a concurrent control group, we recommend that you use
historical controls and provide the rationale for not using a concurrent
control group.
Sample Size
We recommend that you provide the statistical rationale for why the
sample size is adequate to evaluate the device. This should include, but
need not be limited to:
identification of effect criteria (i.e., clinically significant
difference in the response variables to be detected)
desired precision for rate estimates (i.e., defined as ½ width of
confidence interval)
statistical error tolerances of alpha and beta
anticipated variances of response variables (if known)
any assumptions or statistical formulas with a list of references used
reasonable estimations of lost-to-follow-up rates
all calculations used.
We recommend that you base sample size estimates on the precision of
safety and effectiveness outcomes or the detection of a clinically
meaningful difference at 2 years from baseline or from a control group,
taking into account the lost-to-follow-up rates estimated for 10 years
of patient follow-up. If sample size estimates are based on the
precision with which complication rates can be estimated, then the
sample size should be large enough to ensure that this precision is
within a pre-specified number of percentage points based on 95%
confidence intervals.
For example, for sufficient numbers of patients with primary
augmentation or primary reconstruction (i.e., assuming 75% primary
augmentation and 25% primary reconstruction) to determine the rupture
rate with a precision as follows, data on 500 patients would be needed
at 10 years post-implantation. If you estimate a hypothetical 40% drop
out rate at 10 years, then you should enroll at least 850 patients to
achieve 10-year data on 500 patients. This will provide a worst case
precision of +/-4% at a rupture rate of 50%. This precision will improve
as the rate moves away from 50%, with a +/-1.9% precision at a rupture
rate of 5% or 95%. This pooling of cohorts represents the overall worst
case precision. However, FDA recommends that you provide the precision
(i.e., confidence intervals) separately for each patient cohort.

http://www.fda.gov/cdrh/ode/guidance/1239.html

TOXIC DISCOVERY
www.toxicdiscovery.com tel:

A MESSAGE FROM THE NEVADA APPELLANTS TO ALL
DOW CORNING BREAST IMPLANT  CLAIMANTS

As we celebrate the good news and the good works of selfless plaintiffs'
lawyers, breast implant support groups and breast implant survivors who
gave so much of their time and energies and managed, against all odds,
to get the FDA to nix silicone breast implants from re-entering the
market, we are reminded that these lawyers, groups and survivors stood
firm on principle.As most knowledgeable plaintiffs' lawyers, support
groups across the country and breast implant survivors understand, for
years and years the Nevada appellants - - who are in complete agreement
with the Tort Claimants' Committee (TCC) on all issues except one - -
have stood firm on the principle that a non-bankrupt company like Dow
Chemical should not be immunized from the precedent created by Charlotte
Mahlum's successful case in Nevada against Dow Chemical unless it is
willing to file bankruptcy itself.  Against all odds, we prevailed on
the bankruptcy judge in Michigan to allow the Nevadans' claims against
Dow Chemical to go forward unhindered by the Dow Corning bankruptcy. 
The Plan Proponents - - Dow Corning and the TCC - - successfully
appealed this ruling to the honorable Denise Page Hood, the U.S.
District Court Judge in Detroit.   Thus, the Nevadans' victory
before the bankruptcy court - - a victory which allowed all other
claimants such as yourselves to get paid but still allowed the very few
claimants with claims against Dow Chemical to proceed unhindered - - was
short lived.The Nevadans, the Australians, the U.S. Government and
others then appealed Judge Hood's decision to the 6th Circuit Court of
Appeals in Cincinnati, and the 6th Circuit Court of Appeals reversed and
sent the matter back to Judge Hood for further findings that would
warrant the extreme measure of releasing the non-bankrupt Dow Chemical
from liability against those like the Nevadans who did not consent to
such a release by voting for the Plan.  Judge Hood made findings which
purport to warrant that extreme measure, and the Nevadans and the
Australians appealed Judge Hood's decision, again, to the 6th
Circuit.  In the meantime, the U.S. Government settled its appeal with
the Plan Proponents (Dow Corning and the TCC)This entire process of the
Plan Proponents' first successful appeal, followed by the
semi-successful appeal of the U.S. Government, the Australians, and the
Nevadans, took four years.  Now, the Plan Proponents have just settled
with the Australians, such that the Nevadans, 48 in number, with pending
claims against Dow Chemical in Nevada, have very recently become "the
last women standing" objecting the Plan.  We continue to stand on the
important principle that a non-bankrupt company like Dow Chemical should
not be released from liability.  Only Dow Corning, which filed
bankruptcy, should receive that benefit.Yet sometime principle must
yield to reality.  The reality is that no longer can the Nevada women
claim that this important principle for which they are fighting so hard
is not holding up the ability of other women across the country to get
paid.  Because now, apparently, it is. Many of you have called our
office to applaud our efforts and say "stick to your guns on fighting
the Dow Chemical release" no matter what.  More of you have called our
office to suggest that we now abandon our appeal entirely for the
greater good of women everywhere whose payments are being delayed. 
Yet White & Meany can only do what we feel is in the best interests of
their clients, and can only act with the permission of its clients.As
most of you reading this know, the only reason you cannot get paid while
the Nevadans' appeal before the 6th Circuit is still pending is because
of Dow Corning's and Dow Chemical's insistence that they will not allow
the Bankruptcy Settlement and Plan to go forward so long as ANY appeal
of the release of Dow Chemical from liability is pending.  It is this
self-serving insistence which keeps you from getting paid, while at the
same time throwing a huge "guilt trip" on the Nevada women and their 
various tort and bankruptcy attorneys for not bowing to this pressure,
giving up and throwing in the towel.  That fact, coupled with Dow
Corning's and Dow Chemical's ability to veto any settlement of the
Nevadans' claim under the bankruptcy plan itself, is truly the reason
the Plan cannot go forward.  Do not blame the Nevadans.  Do not
blame the Tort Claimants' Committee.  The blame lies elsewhere.Using
intermediaries, the Nevadans have tried, repeatedly, to negotiate the
resolution of their appeal and break the logjam with Dow Corning and Dow
Chemical, all to no avail.  These corporations' words to the Nevadans
can be paraphrased by the late Nikita Khrushchev:  "Because you dared
to cross us and continue to do so, we will bury you."  And, they mean
it, and they don't care if everyone else gets buried as well. Indeed, it
is in their best financial interests not to settle with the Nevadans,
because that would resolve the Appeal, and if the appeal is resolved,
the Plan would go forward.But the Nevadans do care about everyone
else.  I believe the Tort Claimants' Committee cares as well.   So
do numerous other selfless plaintiffs' lawyers and law firms across the
country with large groups of clients clamoring for resolution of their
claims.  I will not convey false hope, but some movement has been made
toward resolution of the Nevadans' appeal, as follows.First, the 48
Nevadans presently appealing the Plan have elected, for the greater good
of women in the other 49 states, to abandon their appeal, provided only
that their bankruptcy fees are paid from another fund and not charged
against them, just as all other claimants' bankruptcy fees (i.e., yours)
are paid from another fund.  That total sum, for all of the bankruptcy
work done over the years to support the principle we have been fighting
for, is slightly less than $400,000.  Once a trust fund is established
- - and where the money comes from is irrelevant - - to pay off alien
that will be assessed against the Nevadans' settlements and recoveries
when and if their cases settle, the Nevadans will dismiss their
appeal.  This trust fund concept is well researched, ethically proper
and workable if there is sufficient interest to fund it.Second, this
offer was made in an open letter to several large plaintiffs' firms with
large inventories of breast implant cases. I will not name names nor put
anyone "on the spot".  I will say that, at least initially, every
attorney in these firms who contacted me expressed enthusiasm for the
trust fund concept.  The trust fund concept was a means of resolving
the Nevadans' appeal and ensuring that the Nevadans who abandoned their
appeal and lost any potential chance to pursue Dow Chemical would not
have to lose twice and take less money in settlements than women in the
other 49 states.  Recall that the bankruptcy fees of the women in the
other 49 states are paid for by the Estate, namely Dow Corning.  Not
so with the Nevada women.  If the trust fund is not established, they
will be abandoning the appeal AND eating the fees. This they will not do
and should not be expected to do.  Nor should their counsel.That is
where the matter sits.  If the Nevadans' appeal is resolved and
settled soon as it could be, the Plan can go forward this year.  The
TCC's website (address below) verifies this.  Indeed, some aspects of
the Plan are already being implemented.  If the Nevadans' appeal is
not resolved soon, payments will be delayed at least another year, and
probably two.  The Nevadans do not wish this because they, too, are
impacted by the delay.  Nor do they want to delay anyone else in the
country from getting paid.  The Nevadans are threatening no one but
are instead responding to the settlement feelers of others.The honorable
6th Circuit Court of Appeals in Cincinnati has recently ordered that
oral arguments be set on the Nevadans' appeal as soon as possible. 

Whichever side loses there will appeal to the U.S. Supreme Court,
causing further delay.The bottom line is but for the establishment of a
$400,000 trust fund for the Nevada women to pay only their legitimate
bankruptcy fees they incurred over the last several years, these appeals
would cease.Yet I am not going to beg for my clients.  I will state
the reality.We still believe fervently that Dow Chemical should not be
released. Yet we temper that belief with the practical result of
fighting to the bitter end to preserve that principle, and have thus
extended the olive branch.I am not the greatest at math, but it would
appear that $400,000 represents less than 1/60th of 1% of the $2.6
Billion Dollar Estate. For what it's worth.  1/60th of 1%.  Go
figure.Feel free to print out this message and give it to your own
attorney. Feel free to call, write or e-mail the Tort Claimants'
Committee at www.tortcomm.org.  Feel free to e-mail me at
gwhite@.... Have your attorney e-mail me.  I have tried
to respond to each and every breast implant survivor and attorney that
has called our office inquiring about the appeal, and I will continue to
endeavor to do so.P.S. No one has suggested this is about greed. 
Indeed, our law firm has represented our clients with claims against Dow
Corning for  over 10 years, and, except for one case against Dow
Chemical and not Dow Corning, has yet to be paid a dime for this 10
years + of effort.  Nor could anyone remotely accuse the Nevada
appellants of being greedy simply because they have steadfastly stood on
a principle they continue to believe in, but will now abandon in the
interest of others.  I call this selfless, but I'm sure a spin doctor
or two out there will try to turn it around against our firm and our
clients.  Have at it, if you will.  At least now we have said our
piece, so that there can be no misunderstanding about our position and
what we are willing to do.

Respectfully,

Geoffrey White, Esq.

Law Offices of White and Meany3185 Lakeside DriveReno, Nevada 
89509775.828.9999775.828.9998 Fax
_____________________________________________________________
RESPONSE OF TORT CLAIMANT COMMITTEE MEMBER RALPH KNOWLES, ESQ.
______________________________________________________________STATEMENT
OF RALPH KNOWLES
First let me thank you for asking, as you always do, for statements in
response to statements of others relating to the work of the Tort
Claimants’ Committee. Second, let us pause for a moment to
consider the enormous victory we all achieved in helping the FDA come to
the right conclusion, at least for the moment, in not approving silicone
gel breast implants as safe. As you know, the common belief was that
this was a done deal. You personally sacrificed to help achieve this
result as did many others.
Let me now respond briefly to Geoff White’s latest message and
solicitation. I am only responding for myself as a member of the Tort
Claimants’ Committee and not for the other individuals on the
Committee.
As you and Geoff both know, I have never personally criticized Geoff or
his clients in any way for their actions in appealing Judge
Hood’s order confirming the Plan of Reorganization. Geoff has an
absolute right to represent his clients as he and they think best. I
will not begin any such criticism today.
On the other hand, I profoundly disagree with the wisdom of the initial
appeal and its continuation. No one should misunderstand the historical
position of the Tort Claimants Committee on the release of Dow
Chemical  issue. We fought long and hard against any such release. We
only agreed to it as the years began to go by and it became absolutely
apparent that we would not be able to submit a Joint Plan of
Reorganization unless we agreed to the Dow Chemical release. It was also
clear that the Court would not likely accept any proposed Plan of
Reorganization unless the Dow family agreed with it.
As the negotiations dragged on, we were literally having victims die.
Others desperately needed (and still need) money for medical care and
other necessities of life. When we reached agreement on all other
issues, we simply could not in good faith with our victims that we
represented continue to delay their rights to either settle or litigate
against Dow because of the release issue. So we agreed to it and the
Plan was approved. I do not regret that decision at all since it was
clearly in the interest of the vast majority of women injured by breast
implants.
As you know, we anticipated that there might be appeals and therefore
successfully negotiated a provision that allows the Claims Office to be
up and running while the appeals would be pending. As a result, that
office is processing claims for those who want to accept the settlement
terms as we speak. But it cannot pay out any money until there is an
effective date and that will not happen until the appeals are resolved.
I have asked Geoff to talk with his clients and reconsider their
continuation of the appeal. It seems just wrong to me for the appeals of
48 women to hold up a remedy for the hundreds of thousands of deserving
victims any longer. However, as I stated at the outset, Geoff and his
clients have an absolute right to do what they are doing and we simply
have a disagreement over what they should do.
As to the $400,000.00 being asked for in order to dismiss the appeals, I
really have very little comment. Many lawyers and clients have spent
money in this litigation for the common good that they will never be
able to recover. It is my opinion that no money can or should be spent
out of the limited fund for claimants to help pay Geoff and
John’s fees and expenses. I would take the same position as to
anyone else who embarked on the same journey as did Geoff and John.
Obviously, what individuals do with their money in response to
Geoff’s message is totally up to them.
Finally, the Tort Claimants’ Committee and those working with it
continue to spend time every day trying to do everything we can
ethically and legally to get to an effective date so the victims we
represent can finally be paid. We regret deeply (perhaps more deeply
than any except the victims) the egregiously long time that has passed
with no remedy available against the Dow family. We will continue to do
that with the help of you and all the others who have been so selfless
in trying to get to that day. Let’s all hope that 2004 will not
end without us getting there together.
_________________________________
Mr. White's Final Comments About Mr. Knowles Above Statement
You may tell your readers I respect Ralph's opinion and hard work, as he
does my opinion and hard work.  I also wanted to clarify that White &
Meany is not seeking a single penny in fees to dismiss the appeal. 
Rather, the fees being sought are for bankruptcy counsel.  Ralph's
response said "Geoff and John's fees" but it should state "John's
(Bankruptcy counsel) fees."    A minor but important distinction.
Geoff White, Esq.
___________________________________
Any further question concerning the above? Please e-mail us at :

nevadaappellantscomments@...

Posted by request -  01/12/04

JOURNAL OF RHEUMATOLOGY

VOLUME 31: NO. 1 JANUARY 2004 Letter

  An Unusually Complicated Case of Primary SS: Development of Transient
"Lupus-type" Autoantibodies Following Silicone Implant Rejection R.A.
Asherson, Y. Shoenfeld, P. Jacobs, C. Bosman .........196
___________________


http://www.jrheum.com/subscribers/04/01/letters.html

An Unusually Complicated Case of Primary Sjogren's Syndrome: Development
of Transient "Lupus-type" Autoantibodies Following Silicone Implant
Rejection To the Editor: We describe the appearance of transient
"lupus-type" autoantibodies (anti-Sm and anti-RNP) with no clinical
evidence of systemic lupus erythematosus (SLE), concurrent with the
rejection of a silicone wrist implant inserted 4 years previously, in a
woman with a 15 year history of primary Sjogren's syndrome (pSS) who had
been followed for 8 years. In addition, she had had persistent cytopenia
(leukopenia and thrombocytopenia) as well as a monoclonal gammopathy.
Progression of pSS to serological and then to clinical SLE has
previously been documented in one patient only. In our patient these
autoantibodies might have been precipitated by silicone implant
rejection.

The sudden occurrence of wrist pain combined with appearance of the
lupus-type autoantibodies makes this probable. After surgical removal of
the implant, these autoantibodies disappeared, without progression to
clinical SLE. The controversial effect of silicone implant rejection on
the emergence of a different pattern of autoimmunity is briefly
discussed. A 61-year-old Caucasian woman had been diagnosed with
hypothyroidism at age 40.

Since 1985, she had complained of increasing dryness of the mouth and
eyes and recurrent submandibular gland swellings. Dental caries,
pyelitis, cystitis, and bronchitis necessitated repeated courses of
antibiotics. Gammaglobulin injections (Beriglobin; Germany) were given
for 3 months. She was also given steroids (prednisone 10 mg daily),
chloroquine (Nivaquine), methotrexate (MTX), and sulfasalazine. MTX and
steroids were discontinued in 1996.

Schirmer's test was dry (positive) bilaterally (< 5 mm) and
submandibular adenopathy was present. An initial mild
hypogammaglobulinemia with a monoclonal peak in the mid-gammaglobulin
region was detected.

The serum M component was 21 g/l and serum gammaglobulin was 5 g/l
(normal 6â€"15 g/l), confirmed by repeated estimations.
Immunofixation for IgG was high positive. The gammaglobulin was of the
IgG lambda type. Bone marrow showed plentiful megakaryocytes and
granulocyte precursors with mild prominence of plasma cells (9%), some
of which were morphologically abnormal with large, definite nucleoli.
Bence-Jones proteinuria and cryoglobulins were not detected. Serum
gammaglobulin concentrations were reported as normal at 8 g/l two years
later. The erythrocyte sedimentation rate remained persistently elevated
(70â€"90 mm/h). Antinuclear antibodies were constantly demonstrated
(1:160 to 1:640, speckled pattern) as were antibodies to Ro and La.
Rheumatoid factor was found in 1999 (Rose-Waaler positive); rheumatoid
factor Latex was 108.8 IU/ml (normal 0â€"39). Antibodies to dsDNA by
Crithidia luciliae were negative.
Antibody titers to parvovirus and to hepatitis C were negative.
Persistent leukopenia and thrombocytopenia were present. The platelet
counts fluctuated to as low as 117 ´ 109and the white blood cell
count to as low as 2.70 ´ 109/l (normal 4â€"12.0). Neutropenia
as low as 0.59 ´ 109/l was detected.

In early 2002, she complained of severe pain in her right wrist, without
preceding trauma. Antibodies to dsDNA by ELISA were initially detected,
but on repeat testing by immunofluorescence (C. luciliae), they proved
to be negative.

ELISA (confirmed by immunodiffusion and Western blot) detected
antibodies to Sm at a titer of 1:5120. Antibodies to nRNP were also
detected by immunoblotting. The appearance of both these antibodies was
transient. Radiographs at this time showed advanced cystic degeneration
of carpal bones and fragmentation of the wrist implant (Figure 1). An
excision arthroplasty was performed. The pain subsided and repeated
immunological testing over the next year showed total disappearance of
the lupus-type autoantibodies. Laboratory investigations for measurement
of antisilicone antibodies could not be undertaken at this time.

Figure 1. Radiograph of right wrist showing multiple cystic degeneration
of carpal bones following fragmentation of trapezium implant performed
in 1997.
HLA testing found the patient to be A24, 11, DR15, 17, B7, 50, and C2,
7. The progression of pSS to serological and then to clinical SLE has
been documented by Satoh, et al1, who described a 69-year-old Japanese
woman with pSS who developed anti-Sm antibodies after a stable course of
9 years, followed by clinical SLE. Lupus associated autoantibodies
(although not to Sm and RNP) following silicone breast implants have
also been reported2. Other accompaniments of pSS in our patient, such as
leukopenia and thrombocytopenia and indeed neutropenia (reported in 10%
of patients with pSS), although previously reported, are also
uncommon3,4. In our patient it was initially combined with a mild
hypogammaglobulinemia, distinctly rare in this disorder, which might
have been related to previous therapy with immunosuppressives such as
MTX, thus possibly adding to her predisposition to recurrent infections.
Garcia-Carrasco, et al5 recently investigated the frequency of
hypogammaglobulinemia in a group of Spanish patients with SS, and found
8% had low IgG levels. These investigators also found evidence of
previous parvovirus infection in 35%. As the hypogammaglobulinemia in
our patient was transient, it is possible that it may have been drug
induced. However, the frequency of infections seemed not to decrease
following normalization of the gammaglobulin levels, and because of
this, the infections may have been related to the underlying SS itself
(because of mucosal abnormalities seen in this condition), combined with
the neutropenia and not because of immunosuppression from drugs or the
hypogammaglobulinemia. Another explanation might be an occult
polymorphonuclear cell dysfunction or abnormality of T cell subsets.
There was a persistent monoclonal gammopathy and a diagnosis of
monoclonal gammopathy of undetermined significance was also made6.
According to several authorities, this may be predictive for the future
development of myeloma7. Monoclonal gammopathies have also infrequently
been documented in association with SS. However, Sugai, et al8 studied
12 Japanese patients with pSS and found a large variety of monoclonality
in their group, while Broggini, et al9 in 358 patients with SS found
this to be present in 6% of patients. Our patient, in addition, also had
hypothyroidism. She thus represents another example of the "mosaic of
autoimmunity" as described by Shoenfeld and Isenberg10. The question
arises as to the relationship of the silicone implant leakage and its
probable rejection and the transient development of these
autoantibodies. This case is not dissimilar to our report11 of a
45-year-old woman who, upon inhalation of a polyclonal
lymphocyte-activating factor, developed 6 different autoimmune diseases
associated with a panoply of autoantibodies. The combination of an
environmental factor and a genetic predisposition is therefore well
known as leading to an overt autoimmune disease. In our case the
silicone may have acted as an "adjuvant". Indeed, injections of silicone
to MRL/lpr strains of mice have been followed by increased titers of SLE
autoantibodies as well as cytokine changes12. Illnesses resembling
rheumatoid arthritis, SLE, and SS, termed "siliconosis," following
silicone breast augmentation have been reported13, as well as a
fibromyalgia/chronic fatigue syndrome. Infections such as
myocobacterial, gram-negative14, and specifically Epstein-Barr virus15
are also known to be associated with the emergence of SLE related
autoantibodies and even overt SLE. The transient appearance of these
antibodies simultaneous to the silicone transplant rejection, and their
disappearance with its speedy removal, makes a strong case for not
considering such transplants in patients with preexisting autoimmune
disease or diathesis. RONALD A. ASHERSON, MD, FRCP, Rheumatic Diseases
Unit, University of Cape Town Health Sciences Center, Groote Schuur
Hospital, Cape Town and The Rosebank Clinic, Johannesburg, South Africa;
YEHUDA SHOENFELD, MD, FRCP, Center for Autoimmune Diseases, Department
of Medicine B, Sheba Medical Center, Tel-Hashomer, Israel; PETER JACOBS,
BM, BCh, MD, PhD, Department of Haematology and Bone Marrow
Transplantation Unit, Constantiaberg Medi Clinic, Cape Town, South
Africa; CHRIS BOSMAN, MB, FCP(SA), The Kenridge Hospital, Johannesburg,
South Africa. REFERENCES 1. Satoh M, Yamagata H, Watanabe F, et al.
Development of anti-Sm and anti-DNA antibodies followed by clinical
manifestation of systemic lupus erythematosus in an elderly woman with
long-standing Sjogren's syndrome. Lupus 1995;4:63â€"5. 2.
Zandman-Goddard G, Blank M, Ehrenfeld M, Gilburd B, Peter J, Shoenfeld
Y. A comparison of autoantibody production in asymptomatic and
symptomatic women with silicone breast implants. J Rheumatol
1999;26:73-7. 3. Schattner A, Friedman J, Klepfish A. Immune cytopenias
as the presenting manifestation of primary Sjogren's syndrome. QJM
2000;93:825-9. 4. Richert-Boe KE. Hematologic complications of rheumatic
disease. Hematol Oncol Clin North Am 1987;1:301-20. 5. Garcia-Carrasco
M, de la Red G, Ramos-Casals M, et al. Low positivity of anti-Ro/SS-A
and anti-La/SS-B in patients with primary Sjogren's syndrome and
hypogammaglobulinaemia [abstract]. Autoimmun Rev 2002;1:51. 6. Kyle RA,
Lust JA. Monoclonal gammopathies of undetermined significance. Semin
Hematol 1989;26:176-200. 7. Terpos E, Angelopoulou MK, Variami E,
Meletis JC, Vaiopoulos G. Sjogren's syndrome associated with multiple
myeloma. Ann Hematol 2000;79:449-51. 8. Sugai S, Shimizu S, Tachibana J,
et al. Monoclonal gammopathies in patients with Sjogren's syndrome. Jpn
J Med 1988;27:2-9. 9. Broggini M, Cavallo A, Baratelli E, et al.
Monoclonal gammopathy of uncertain significance in rheumatic disease.
Recenti Prog Med 1990;81:306-9. 10. Shoenfeld Y, Isenberg D. The mosaic
of autoimmunity; Research monographs in immunology. Vol 12. Amsterdam:
Elsevier Science Publishers; 1989. 11. Rahamim-Cohen D, Shoenfeld Y. The
mosaic of autoimmunity. A classical case of inhalation of a polyclonal
activating factor in a genetically and hormonally susceptible patient
leading to multiple autoimmune diseases. Isr Med Assoc J 2001;3:381-2.
12. Schaefer CJ, Wooley PH. The influence of silicone implantation on
murine lupus in MRL lpr/lpr mice. J Rheumatol 1999;26:2215-21. 13.
Borenstein D. Siliconosis: a spectrum of illness. Semin Arthritis Rheum
1994;24 Suppl 1:1-7. 14. Isenberg DA, Maddison P, Swana G, et al.
Profile of autoantibodies in the sera of patients with tuberculosis,
Klebsiella and other gram-negative infections. Clin Exp Immunol
1987;67:516-23. 15. James JA, Neas BR, Moser KL, et al. SLE in adults is
associated with previous EBV exposure. Arthritis Rheum 2002;44:1122-6.
  Informed Consent Begins With Informed Individuals
TOXIC DISCOVERY
601 W. Nifong - Bldg. 5AColumbia, MO. 65203
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Latest cosmetic surgery deaths raise alarm

http://www.sun-sentinel.com/news/local/southflorida/sfl-rxtummy17jan17,0,115
7062.story?coll=sfla-home-headlines

By Fred Schulte and Bob La Mendola
Sun-Sentinel

Posted January 17 2004

Five Florida residents have died since May after liposuction or other
surgery to reshape their bodies, including two people operated on at the
same surgical center in Fort Lauderdale.

Two patients died shortly after operations at the Florida Center for
Cosmetic Surgery on Middle River Drive in Fort Lauderdale, which has
targeted minorities and gay men with aggressive advertising and boasts a
Web site that promises "safe, beautiful, long-lasting results."

It is the third time in recent years that cosmetic surgery deaths have
spiked in an eerily similar pattern, defying some of the nation's
strictest patient safety standards and repeated assurances from state
health officials that the procedures can be done safely in medical
offices.

Upon hearing of the five latest deaths, Dr. Elisabeth Tucker of
Pensacola, chairwoman of the Florida Board of Medicine, said she was
distressed and would make sure the Florida Department of Health
investigates each one.

"We need to look at all of those cases, and see if there's any common
thread and see if we need to address it," Tucker said.
James K. "Jamie" McCormick died in his Fort Lauderdale apartment on Nov.
14, his 51st birthday, the day after facial surgery by Dr. Timothy
Alexander, one of the Florida Center's five surgeons, state records
show.

Jacquelyn V. Roberts, a 45-year-old mother of three and a 13-year South
Florida Sun-Sentinel employee, died on Jan. 7, about two days after a
tummy tuck and liposuction performed there, family and friends said.

The Broward County Medical Examiner's Office has yet to determine the
cause of either death. The center's medical director, Dr. Jeffrey Hamm,
and the chief executive of an Atlanta-area firm that owns the center
said they would have no comment on the deaths, citing patient
confidentiality laws.

"We can't talk specifically about any cases," said Hamm, who has been
the center's medical director for the past year. The center is owned by
American Plastic Surgery, with offices in four states.

Florida health officials have struggled to assess the safety of office
surgery since 1998 when a Sun-Sentinel investigation found dozens of
deaths dating to the 1980s that followed seemingly routine operations
such as face-lifts, liposuction and tummy tucks, in which loose fat is
cut from around the stomach.

The newspaper has confirmed 36 deaths since January 1997, most of them
after office surgery, based on autopsy reports and other state records.
At least 14 followed tummy tucks, often combined with liposuction. An
estimated 77,000 cosmetic procedures are done in the state annually,
although precise numbers are hard to come by.

Dr. Yoav Barnavon of Hollywood, president of the Florida Society of
Plastic Surgeons, said that the "vast majority" of people "have no
complaints and end up with a great result." But he acknowledged that
complications such as pulmonary embolism, in which a blood clot lodges
in the lung, can be fatal and that patients should be fully advised of
these risks.
Safety standards

Twice since 2000, state officials have reacted to a cluster of deaths
within a few months. Four fatalities within five months in 2000 led the
Florida Board of Medicine to order a three-month moratorium on office
surgery statewide.

Upon lifting the ban in November 2000, the medical board unveiled tough
new safety standards -- said to be among the nation's most stringent --
requiring surgical offices to become accredited, limiting the length of
cosmetic procedures and restricting some patients at high risk of
complications to hospital operations only.

The state also began requiring doctors to report all deaths and serious
complications to the state within 15 days, which many surgeons expected
would demonstrate the safety of the office setting.

But during the first nine months of 2002, five patients died after
office surgery, leading the medical board to review the restrictions.

Both Broward patients who died expected to reshape their figures to look
younger and fitter.

McCormick, a bartender, had decided to restore fading youth with eye
surgery, a forehead lift, liposuction of fat in his throat and a chin
implant, a friend said.

At first, McCormick had planned to have just his eyes done, said Duran
Schmidt, 45, a longtime friend who drove McCormick to and from the
surgery. He decided to have more work done after the center offered a
discount package, Schmidt said.

McCormick was still groggy and could barely walk when the surgery center
discharged him, Schmidt said. He was sent home with bottles of a
painkiller and a muscle relaxer, but needed help reading the labels and
instructions. Schmidt said he could not believe his friend of 14 years
is dead because of something as superficial as droopy eyes. "Something
went way wrong," Schmidt said. "That shouldn't happen."

Roberts' doctors had told the Sun-Sentinel employee to lose weight. She
had tried dieting but could not shed the pounds, her co-workers said.

She knew about the Florida Center from family members and decided to try
it, said Gladys Perez, who sat next to Roberts as part of a team that
drew up automotive and real estate ads via computer.

Roberts told friends she was happy that physicians had cleared her for
surgery despite health problems that included high blood pressure,
diabetes and a history of smoking.

"She was very excited about the surgery," Perez said. "She thought she
would look better."

Roberts recovered at her parents' condo in Lauderdale Lakes, in the same
complex where she lived. She had been feeling sick after the surgery but
two days later she had grown so weak that her parents called an
ambulance, co-workers said. She died hours later at Florida Medical
Center, leaving three sons, ages 19 to 25.
"She was wonderful," said her supervisor, Bob Dunn. "She was the type of
person who was a friend to everyone on the floor. She always came to
work in a great mood."

Death from embolism

Doctors at the Florida Center said they are careful about making sure
beforehand that patients are good candidates for surgery.

"The Florida Center does everything it can do to screen patients [in
advance] and to take care of patients during the procedure and after the
procedure to the best of our ability," said Dr. Roger Gordon, who
performed Roberts' surgery.

State records show that the first person to die in 2003 was Claudine
King, 63, of Winter Park. She suffered a pulmonary embolism and died on
May 13, a day after liposuction and a tummy tuck at Preferred Plastic
Surgery of Orlando, according to an incident report filed by the
surgeon, Dr. Thomas G. Fiala of Altamonte Springs.

In the report, Fiala called King a "reasonable candidate" for the
operations because she had no major health problems and had quit smoking
three years earlier, the report said.

King had had a face-lift earlier and experienced "no previous
difficulties with anesthesia," the surgeon wrote, adding: "The risks of
surgery, including major complications, were discussed and documented in
detail, both at initial consultation and at [her] pre-operative
appointment."

An autopsy confirmed she died of an embolism. Fiala declined to discuss
the case.

In Aventura, doctors at the Sunny Island Cosmetic Surgery suspect an
embolism also killed Maria Borrego, 48, who died Dec. 3, nine days after
having liposuction and a fat transfer to the buttocks by Dr. Fabio A.
Castro, according to a report filed with the health department.

While in the recovery room, Borrego said she was "getting anxious,"
according to the report. "We made the decision to transfer the patient
to the hospital for further evaluation and treatment for suspicion of
fat embolism, " the report said. She died at Aventura hospital nine days
later. The cause of death is "pending further investigation," according
to Miami-Dade Medical Examiner's Office records.
Castro could not be reached for comment.
In the fifth case, Julie Rubenzer, 38, of Sarasota, died after going
into a coma near the end of breast implant surgery on Sept. 25 in the
Sarasota office of Dr. Kurt Dangl.

She never regained consciousness and died the day after Christmas in
Wisconsin, where her patients had taken her. In reporting the incident
to the state, Dangl called her operation "routine and uncomplicated." He
could not be reached for comment with a phone message at his office.

Dr. Hector Vila Jr., an anesthesiologist at the H. Lee Moffitt Cancer
Center in Tampa, who has studied office deaths in Florida, said that
complications such as embolisms can happen even when every precaution is
taken.

"We're trying to do everything we can to prevent them. The public needs
to know about this, to know this is a risk and a fairly high risk," he
said. He also said that combining tummy tucks and a significant amount
of liposuction may present problems.

Medical board chairwoman Tucker said her big fear is that cosmetic
surgeons, in the drive to bring in business, are not evaluating patients
closely enough to screen out those with health problems who would be at
high risk of complications, Tucker said.

Tucker called it unsettling that in four of the five cases, the patients
were put under sedation by anesthesiologists, who are physicians. During
several years of wrangling, the board of medicine initially tried to ban
nurse-anesthetists from administering sedatives during complex cosmetic
surgery. Eventually, the board allowed nurses to do so if the surgeon
had certain training.

Fred Schulte can be reached at fschulte@... or
954-356-4591. Bob LaMendola can be reached at
blamendola@... or 954-356-4526.

via Myrl

Liposuction Death Rate 'Unacceptable'
By Afsun Qureshi

http://www.talksurgery.com/consumer/safety/safety00000041_1.html

January 4, 2000 -- The death rate for liposuction, the popular cosmetic
surgery performed mainly in doctors' offices and clinics, is 20 to 60
times higher than the death rate for all operations performed in
hospitals, a newly published survey shows.
Hospital patients undergoing all types of surgery, including risky
procedures on the sickest of the sick, die at a rate of 1 in 100,000 to
1 in 300,000.
But the liposuction survey, in which 917 plastic surgeons voluntarily
reported deaths caused by liposuction in exchange for confidentiality,
shows that for every 5,000 liposuction procedures from 1994 to 1998, one
patient died - 95 in all. Among the causes were blood clots, anesthesia
problems and internal injuries after the liposuction procedure.
More than 172,000 Americans have liposuction, a procedure in which fat
is sucked out of thighs, bellies and other parts of the body, every year
by board certified plastic surgeons. Any doctor can perform liposuction,
so the actual tally may be more than double that.
Because liposuction is widely regarded as simple and safe, the high
death rate of comes as a shock to patients and medical safety advocates.
"The difference (in death rates) is gigantic," says Ellison Pierce,
executive director of the Anesthesiology Patient Safety Foundation,
which has been at the forefront of a national effort to reduce medical
errors. "That's a completely unacceptable mortality rate."
Plastic surgeons say they have addressed many of the causes of fatal
flaws in liposuction procedures. They suspect that current death rates
during or after liposuction may be half of what was found in the survey,
which is reported in the Journal of the American Society of Plastic and
Reconstructive Surgeons.
"We're on top of this problem," says Jack Bruner, a plastic surgeon in
Sacramento and chairman of the society's liposuction task force. He says
a more detailed study of mortality rates is under way, and results are
due in two years.
Patient safety experts, however, say they are not surprised by the rate
within the growing practice of office surgery.
"There are no rules for office-based surgery whatsoever," Pierce says.
Doctors must follow strict federal rules for blood and urine samples
taken in offices, but there are no rules that apply to surgery,
including liposuction procedures in the offices. The result, Pierce
says, is that "surgery in doctors' offices is rampant with death."
Because elective office surgeries are such good business - payment
upfront, no insurance hassles, and the doctor can set the fee - the
practice has lured all kinds of doctors into the field. A doctor can
attend a seminar at a hotel and learn how to perform liposuction within
a few hours, Rohrich says.
Board-certified plastic surgeons perform more than 172,000 liposuction
procedures each year. But because the field is open to many doctors, the
actual total could be more than double that number. The popularity of
liposuction poses a risk to patients. The survey says "liposuction has
become trivialized" at a time when "the extent of complications may well
be underreported."
The surgery is more complex than it looks. The drugs commonly used by
anesthesiologists can cause dangerous "hangovers" that can threaten
patients who go home after surgery. Removing too much fat or performing
other cosmetic procedures at the same time raises the risk of
complications.
The topical anesthetic lidocaine, pumped into the area under the skin
where fat accumulates, helps limit pain during the procedure and during
the recovery. But when large amounts of fat are removed - some doctors
have been known to suction out as much as 20 pounds during a procedure -
a larger quantity of lidocaine is used sometimes. In the hours after the
procedure when the patient is at home, dangerous levels of lidocaine can
accumulate in the bloodstream.
High levels of lidocaine can kill by causing the heart to slow and
misfire and the blood pressure to fall. Experienced plastic surgeons say
some patients should be kept overnight in a hospital, and they generally
avoid removing large amounts of fat in a single procedure.
Rudolph de Jong, an anesthesiologist and surgeon from Columbia, S.C.,
and one of the authors of the survey, says the study shows a "shocking"
death rate of almost one per 5,000 liposuction surgeries. The death rate
for all hospital surgeries ranges from one in 100,000 to one in 300,000.
"Patients should assume nothing," says Rod Rohrich, a plastic surgeon
and co-editor of Plastic and Reconstructive Surgery, the journal that
published what he calls an "eye-catching" liposuction death-rate survey
this month. "Anybody can do liposuction. Even dentists have been doing
it."
Rohrich thinks the study - a random survey that doctors voluntarily
responded to - was flawed because it could not track and compare the
results of every case in question. Such a study is under way, and
results are expected in about two years.
Rohrich suspects that the actual death rate is lower, but he wanted to
publish the results from de Jong, in part "because we don't want to hide
anything." He thinks that patients should be aware of the dangers and
question their doctors about surgical safety: Is the doctor
board-certified? How many procedures has he/she done? Does the doctor
have surgical privileges at a hospital? Is the office equipped for an
emergency?
But de Jong thinks the death rate might be higher than the survey shows
if every doctor who performed liposuction could be surveyed. His survey
went to only board-certified plastic surgeons, "the cream of the crop,"
he says.
The medical risks of what is largely considered a benign procedure raise
larger questions about patient safety, says Ervin Moss, an
anesthesiologist and patient-safety advocate who has lobbied for safety
rules for office surgeries.
As many as 98,000 people are killed each year by medical mistakes,
making it a leading killer in the USA. Moss and others have worked for
years to implement "systems approaches" to medical safety in hospital
operating rooms. The safety changes range from designing more
error-proof machines to using simulators for cockpit-type crisis
training. The work has helped drive the surgical death rate in hospitals
down dramatically over the past 20 years, according to a recent
Institute of Medicine report on the problem.
Moss says similar efforts are urgently needed in office-based surgery,
which is becoming more common as doctors look for ways to treat their
patients for less money. Performing surgery in the office is much
cheaper and usually more profitable.
About 25% of surgeries are expected to be performed outside hospitals
within three years, in part because of financial incentives, Moss and
others say. Surgeons are removing tonsils and implanting tubes in the
ears of children, performing arthroscopic fixes on knees and shoulders
of adults, and more. Doctors who perform operations in their own
facilities rather than in a hospital get extra insurance money to cover
facility costs. The hospital, on the other hand, may charge more for a
surgery as it struggles to recoup costs from emergency rooms and other
money-losing departments.
The result has been a rise in surgical centers in office buildings and
strip malls across the nation.
"They're like 7-Elevens," Moss says.
Some doctors go to the trouble and expense of duplicating the safety
standards in a hospital operating room; many do not. And only a few
states even try to force doctors to meet office surgery safety
standards. The result is a dramatic difference among operating
environments.
In a hospital, a surgeon must pass a peer review to be allowed to
perform a specific surgical procedure. The federal government requires
state-of-the-art equipment to be on hand in case complications threaten
the patient's life. And somebody who specializes in anesthesia puts the
patient to sleep and watches over the patient as the surgeon works.
In the doctor's office, the physician can perform any procedure in
complete secrecy without peer review.
There is no requirement for basic emergency equipment to be on hand
during surgery.
A woman who was recently widowed after her husband had liposuction says
she and her husband never knew there were so many differences. But his
death taught her that signing up for liposuction can put a person at a
higher risk of death than she ever dreamed.
"You're not a patient when you have elective surgery; you're a buyer,"
Altschwager says. "Buyer beware."

via Ilena

WASH POST: Breast Implants / Insurance A Complicated Issue

http://www.washingtonpost.com/wp-dyn/articles/A26262-2004Jan17.html

A Complicated Issue

A Weekly Check on Health Care Costs and Coverage Tuesday, January 20,
2004; Page HE02

Amy Kephart's routine mammogram last year proved to be anything but
routine.

The image for her left breast led her doctor to recommend a needle
biopsy.

The biopsy, Kephart said, led to an infection. The infection required
surgery that kept her in Inova Fair Oaks Hospital for several days in
September, costing her more than $1,000 and her insurance plan thousands
more.

Case closed? No. In December, her insurer, the Health and Welfare Fund
of the United Food and Commercial Workers Union, asked the various
providers for its money back, saying Kephart's claims had been paid in
error. "It has come to our attention," the fund wrote, that Kephart's
treatment "was due to complications from previous breast implants
approximately 10 years ago," and under Kephart's policy,
"Complications resulting from cosmetic surgery are not covered."

Kephart, who lives in McLean and works for Safeway, is appealing the
denial, and she has hired an attorney to try to ensure that she won't be
stuck with the bills. Regardless of how her case turns out, it
illustrates some of the problems facing women who have breast implants,
either after mastectomy or to enhance their physique.

"This implant needs to be removed in order to allow for resolution of
the . . . infection," plastic surgeon Andrew G. Goldberg wrote in a memo
before operating on Kephart. In a follow-up, Goldberg reported that he
had found the implant to have been ruptured, "with free silicone within
the left breast tissues."

"Usually things are kind of black or white," Goldberg said, but
sometimes deciding whether a breast problem is a complication of an
implant "is absolutely a gray zone," and "unfortunately the insurance
companies are making the final determination."

Kephart said she was unaware of her policy's exclusion of
cosmetic-surgery complications. If she had known that the biopsy and
mammogram might confront her with expensive health problems, she said,
she would have skipped them.

"You certainly don't want her not to have mammograms," said Diana
Zuckerman, president of the National Center for Policy Research for
Women & Families, "because the mammogram could help you find out if you
have breast cancer."

Zuckerman said she did not know of others avoiding tests for financial
reasons, but "I hear more from women who don't want to get mammograms
because they're afraid their implants will break" during the exam.

"I've spoken to so many women who say this has happened to them," said
Zuckerman, whose group promotes research on the safety of implants. "It
certainly seems likely that a mammogram can break a breast implant."

Indeed, the Food and Drug Administration urges women to alert mammogram
technicians to "use special techniques . . . to avoid rupturing the
implant."
-- Tom Graham

The System welcomes comments from patients, providers, insurers and
others about the delivery of health care. While we cannot advocate on
behalf of individuals, we are looking for examples of problems and
solutions that may direct our reporting. Contact us by U.S. Mail at the
address that appears on Page F2 or by e-mail at thesystem@....
Do not send original documents.

According to Katrina Berne, Ph.D.,

"Biofeedback applications are relevant to a number of CFS/FMS symptoms,
including muscle tension, pain, and headache. The basic principle is
simple: to provide auditory or visual feedback when a desired
physiological change is produced. Brain waves, blood flow, and muscle
tension can be measured with electrodes taped to various body points,
with sounds or lights offering feedback in regard to muscle tension or
other relevant functions. By associating the desired state with positive
feedback, the behavior change is learned and reinforced, becoming easier
to achieve over time.

Ultimately, the patient is able to produce the response without the aid
of equipment and apply the techniques in daily life."

(Source: Chronic Fatigue Syndrome, Fibromyalgia and Other Invisible
Illnesses, by Katrina Berne, Ph.D.

Published by Hunter House and available at www.hunterhouse.com or by
calling 1-800-266-5592.

This tip provided courtesy of ImmuneSupport.com

From: ilena2000@... (ilena rose)

Date: Fri, Jan 23, 2004, 4:59pm (CST+6)

To: dz@...

Subject: Breast Implants Don't Increase Brain Cancer Risk?

~~~ Wish I could believe this so called "study" ~~~

Breast Implants Don't Increase Brain Cancer Risk

http://www.newswise.com/articles/view/502833/

The best available scientific evidence shows no increased risk of brain
cancer among women with silicone breast implants, reports a study.

Newswise — The best available scientific evidence shows no increased
risk of brain cancer among women with silicone breast implants, reports
a study in the February Annals of Plastic Surgery.

"Our results, based on the highest-quality incidence data, rule out any
increase in brain cancer risk after breast implant surgery," said Joseph
K. McLaughlin, Ph.D., and Loren Lipworth, Sc.D., of the International
Epidemiology Institute.
Drs. McLaughlin and Lipworth pooled data from four long-term follow-up
studies of brain cancer risk after cosmetic breast augmentation surgery.
The studies included nearly 10,500 women with breast implants, some
followed up for as long as 29 years.

Just 12 of the women developed brain cancer. This compared with an
expected 9.6 cases of brain cancer, based on population statistics. The
difference between observed and expected cases was not statistically
significant.

The findings contradict a 2001 study suggesting that women with breast
implants are at more than double the risk of death from brain cancer.
However, that study had several major weaknesses, particularly its
reliance on death certificates as the only source of information on the
presence of brain cancer.

In contrast, the new "meta-analysis" is based mainly on studies from
Scandinavian countries, including complete medical records and long-term
follow-up in a very large group of patients.
"Even at the upper boundary of our summary estimate, our results rule
out any 2-fold or greater excess of brain cancer incidence among women
with breast implants," Drs. McLaughlin and Lipworth conclude.

In 1992, the U.S. Food and Drug Administration placed a moratorium on
the use of silicone implants for cosmetic breast enhancement, citing
concerns over autoimmune disorders, cancers, and other claimed harmful
effects. None of the many studies performed since that time has shown
convincing evidence that breast implants increase the risk of any type
of cancer, including breast cancer or brain cancer.

The new study comes on the heels of a January 8 decision by the FDA to
deny one manufacturer's application to put silicone breast implants back
on the market. Drs. McLaughlin and Lipworth note that, "Our results add
to the large body of scientific evidence finding no increased risk of
brain cancer or other diseases in women with breast implants."
"Breast Implants Don't Increase Brain Cancer Risk" Annals of Plastic
Surgery
January, 2004

"Blue Vinyl," is a documentary film currently airing on HBO, which
exposes the dangers of Polyvinyl Chloride,  Since all breast implants
have silicone in them, which contains PVC, I felt it would be of
interest to us.  ~ Lany ~



My House is Your House

Address:http://myhouseisyourhouse.org/

Changed:7:42 PM on Tuesday, November 11, 2003

http://myhouseisyourhouse.org/

Chemicals Found in Silicone Gel:

*1. Methyl Ethyl Ketone - neurotoxin

*2. Cyclohexanone - neurotoxin

*3. Isopropyl Alcohol (Isopropanol)

*4. Denatured Alcohol (Ethanol)

*5. Acetone - neurotoxin

*6. Urethane (Ethyl Carbamate)

  *7. Polyvinyl Chloride (Liquid Vinyl) - neurotoxin, carcinogen

*8. Ethyl Acetate - neurotoxin

*9. Amine

10. Toluene - carcinogen/neurotoxin

11. Dichloromethan (Methylene Chloride) - carcinogen at any exposure
level

12. Freon (Chloromethane)

13. Silica

14. Flux (Sodium Flouride)

15. Solder (lead-based solder)

16. Lofol (Formaldehyde)

17. Talcum Powder

18. Oakite (Trisodium Phosphate)

19. Eastman 910 Glue (Methyl 2-cyanoacylates)

20. Ethylene Oxide (ETO) - carcinogen

21. Carbob Black - carciongen at any exp. level

22. Xylene - neurotoxin

23. Hexone

24. 2-Hexanone

25. Thixon-OSN-2

26. Antioxidant (Rubber)

27. Stearic Acid

28. Zinc Oxide

29. Naptha (Rubber Solvent)

30. Phenol - neurotoxin

31. Benzene - carcinogen/neurotoxin

32. Lacquer Thinner

33. Epoxy Resin

34. Epoxy Hardener 10 & 11

35. Printing Ink

36. Metal Cleaning Acid

37. Color Pigments as Release Agents

http://community-2.webtv.net/lany25/ChemicalsFoundin/

NYTImes : Many Surprised By Bold Moves At the F.D.A.

http://www.nytimes.com/2004/01/25/national/25FDA.html?ei=5062&en=d130e935be69c00\
6&ex=1075611600&partner=GOOGLE&pagewanted=print&position=

EXCERPRT: Dan Cohen, the new vice president for global government
affairs at Inamed, which the F.D.A. told this month to do more research
if it wanted to return its silicone breast implants to the market, said
Dr. Kessler was "overly political, capricious, and didn't seem to have
science at heart as opposed to an agenda."
~~~~~~~~~~~~~~~~~
Inamed's New PR Flack has it all upside down and backwards ... LOL ...
like Inamed doesn't have an "agenda." Dr. Kessler certainly did ...
protecting the public's health against dangerous medical devices.
----------------------------------------------
January 25, 2004
Many Surprised By Bold Moves At the F.D.A. By GINA KOLATA
ome people thought they knew what to expect of the Food and Drug
Administration under President Bush: It would be attuned to business and
sensitive to religious conservatives. It would put off difficult
decisions and issue fewer regulations.
Its commissioner, Dr. Mark B. McClellan, is a Republican and the brother
of Mr. Bush's press secretary. Traditional Republican supporters, like
large drug companies, praise him, so it might seem predictable that he
would take a strong stand as he is doing this week against importing
prescription drugs from Canada, a practice that undercuts prices here.
But the decision has also put him in conflict with several governors —
some of them Republican — and legislators who want cheaper drugs from
Canada.
A number of other decisions by Dr. McClellan have kept the Food and Drug
Administration in the spotlight as one of the more activist agencies in
the Bush administration. Granted, critics say that some of the rulings
— like banning ephedra — were years in the making, but other people
note that unlike, say, the Environmental Protection Agency, the F.D.A.
has not seemed in retrenchment on regulatory matters.
The agency's announcement last month that it would prohibit the sale of
ephedra was a move sought by liberal Democrats like Senator Edward
M. Kennedy and consumer groups like Public Citizen's Health Research
Group. That tough stand was just the beginning of a crackdown on
supplements, Dr. McClellan promised.
"While most supplements are probably safe in the dose people take them,
we are concerned about a number of other dietary supplements that are
currently on the market," he said in a speech Tuesday. "And we intend to
do more to take a closer look at them."
In another move that could be construed as hindering business, Dr.
McClellan deferred a decision on whether to allow silicone breast
implants back on the market after more than a decade-long hiatus. He
said the F.D.A. needed more data on safety, especially on ruptures, how
to detect them and what to do when they occur.
"I've been pleasantly surprised," said Cynthia Pearson, executive
director of the National Women's Health Network, which wanted ephedra
banned and more safety data on implants.
Other F.D.A. watchers were surprised when the agency signaled a
willingness to consider allowing a prescription morning-after pill to be
sold over the counter. The pill, called Plan B, can prevent pregnancy
after unprotected sex.
Women's groups, like the National Women's Health Network, strongly
support making Plan B available over the counter, but some religious
groups strongly oppose it. Believing that pregnancy begins with
fertilization, they say the pill can prevent a fertilized egg from
implanting, and so it induces abortion.
But the agency put on its advisory committee people known to support
offering the pill over the counter. And the committee voted
overwhelmingly to make the drug available without a prescription. A
final decision is expected by mid-February.
"Miraculously, I was appointed to the committee," said Dr. James
Trussell of Princeton University, who has always wanted the drug to be
offered over the counter.
Some consumer groups argue that the Food and Drug Administration is too
cozy with the industries it regulates. In fact, even industry groups
that appear to have been hurt by some of Dr. McClellan's decisions speak
well of his approach to the job.
He "isn't what most people would have expected from a Republican
administration," said Dr. Annette Dickinson, president of the Council
for Responsible Nutrition, a trade group for the dietary supplement
industry. But, she said, "he's been a breath of fresh air."
She said her group wanted the agency to stop supplement makers from
making false health claims or flouting good manufacturing practices, and
supported the ephedra ban.
Others regulated by the F.D.A. like the attention they are getting.
Dr. Rhona Applebaum, the executive vice president and chief scientific
officer of the National Food Processors Association, said that in her 20
years in the industry, she had never seen an F.D.A. commissioner pay so
much heed to food. "So yeah, we're pretty excited."
Part of Dr. McClellan's success, said Dr. Alan M. Garber, an internist
and economist at Stanford, is that he is a pragmatist, not an ideologue.
He also has a style that can be immensely appealing.
"McClellan is so personable and comes across as a person of such great
integrity that it's hard to find somebody who says something negative,"
said Wayne Pines, who was the agency's associate commissioner for public
affairs under Dr. David A. Kessler, who is now a consultant to companies
dealing with the F.D.A.
The same cannot be said of Dr. Kessler, who served under President Bill
Clinton and the first President Bush and angered industry officials by
halting the sale of silicone breast implants and seeking to regulate
tobacco as a drug.
Dan Cohen, the new vice president for global government affairs at
Inamed, which the F.D.A. told this month to do more research if it
wanted to return its silicone breast implants to the market, said Dr.
Kessler was "overly political, capricious, and didn't seem to have
science at heart as opposed to an agenda."
Dr. Kessler would not discuss how his management style differed from Dr.
McClellan's, but he did compliment his decisions on breast implants and
supplements. "He got it right," Dr. Kessler said.
In a telephone interview, Dr. McClellan said he was surprised to be so
roundly praised.
"I thought I managed to tick everybody off," he said. "It's one of the
things that's kind of freeing about this job. We get criticized no
matter what we do." But, he said, he wants to continue the agency's long
tradition of "getting the science right."
"A lot of people have a pretty cynical view of Washington, but I really
don't," Dr. McClellan said. "It's a little corny, but it's focusing on
the right thing to do."
Some find him hard to pigeonhole.
For example, consumer groups objected and large drug companies applauded
when he warned that it was illegal to import prescription drugs from
Canada. But just the opposite happened when he changed regulations to
make generic drugs available sooner when a drug's patent expired. Both
drug companies and consumers approved of the agency's investigations and
prosecutions of drug counterfeiters.
With foods, Dr. McClellan and his staff examined whether nutritional
science could justify new claims. In the first change to food labels in
a decade, last year he announced a proposal for labels to list so-called
trans fats, which can increase cholesterol levels, a move that angered
some companies. But, in an action favored by food manufacturers, he
would allow them to list qualified claims about the health benefits of
foods and nutrients.
In the case of dietary supplements, Dr. McClellan's proposal last month
to ban ephedra got most of the attention.
But that, he said, "was just the tip of the iceberg." He said he had
also issued 75 warning letters to supplement makers — a fivefold
increase from 2002, before he took office — and seized millions of
dollars worth of supplements that made false health claims or that were
unapproved drugs masquerading as supplements. The agency also stopped
the importation of 664 shipments of potentially dangerous or fake diet
supplements.
At the same time, the agency's actions on contentious women's health
issues have been watched closely from all sides.
For example, Dr. McClellan insisted that all hormone pills to alleviate
symptoms of menopause include hard-to-miss warning labels about their
risks for cancer and heart disease.
He also has not bowed to pressure from groups that say that
mifepristone, a drug once known as RU-486 and approved in 2002 to induce
abortions early in pregnancy, is unsafe.
But for all the examples of his attention to regulation, some consumer
advocates say he should be doing more.
Dr. Michael F. Jacobson, the executive director of the Center for
Science in the Public Interest, a consumer advocacy group, said he saw
"a real pattern of actions that undercut the public's health." He said
of the plan to allow more health claims on food labels, for example,
that Dr. McClellan was "just ignoring the law." His group and Public
Citizen, another advocacy group, have sued the agency over such
labeling, saying it would violate the current food labeling law, which
requires health claims to be substantiated by "significant scientific
agreement."
Dr. Sidney Wolfe, director of Public Citizen's Health Research Group,
has a litany of complaints in addition to the food labels that are, he
said, "a flagrant violation of the Nutrition Labeling and Education
Act."
Among the complaints, the F.D.A. did not propose banning ephedra until
the major manufacturers had stopped making it, because they could not
get product liability insurance, Dr. Wolfe said. The delay "was just
inexcusable."
Mr. Pines, the former assistant commissioner, said that while advocacy
groups had raised objections and sued the agency no matter who was
commissioner, the striking and reassuring fact was that "the F.D.A.
continues to make decisions based on the public health."
"Any administration coming in can certainly change some of the nuances,"
Mr. Pines said. "But it's too big a ship to turn in a new direction."
~~~~~~~~~
www.BreastImplantAwareness.org
__________________________________

From: Kathy Nye

Subject: POST: Question about 1995 article & Implants in the news &
Correction
Hi, I found this article and the last sentence has me wondering. If a
Federal judge said Dow Chemical cannot be excluded, how can Dow Corning
push it into the settlement? Why should Dow Chemical be excluded? Hmmmmm
Kathy Nye


Title: CONGRESSMAN SEEKS DOW CORNING HEARINGS ,  By: Hess, Glenn,
Chemical Marketing Reporter, 00900907, 7/24/95, Vol. 248, Issue 4
Database: Business Source Elite
Section: REGULATORY WATCH
CONGRESSMAN SEEKS DOW CORNING HEARINGS

A member of the House Science Committee is calling on Justice Department
to investigate charges that Dow Corning Corporation was less than
forthcoming when it testified before

Congress about silicone breast implants.
Rep. James Traficant (D-Ohio) claims that in 1990 testimony before a
congressional panel, the company lied about the safety of the implants.
"I am asking Attorney General Janet Reno to look into possible criminal
violations," he told a Capitol Hill news conference. Rep. Traficant also
charges that Dow Corning tried to manipulate US bankruptcy laws in order
to avoid paying full damages agreed to in a settlement of injury
lawsuits.

Dow Corning says it has been accurate in its responses at congressional
hearings and maintains it filed for bankruptcy court protection in order
to make sure women who sued could get their money. The company says it
will cooperate fully with any investigation.

Rep. Traficant and 15 other House members are also asking Rep. William
Clinger (R-Pa.), chairman of the House Government Oversight & Reform
Committee, to hold hearings on Dow Coming. The lawmakers seek a hearing
on whether the company withheld information from Congress and whether it
"manipulated Federal banking laws" in declaring bankruptcy in order to
"escape liability" from implant recipients.

In a letter to the chairman, the congressmen allege that Dow Coming
denied minors of a bankruptcy filing during settlement negotiations,
when the firm agreed to contribute $2 billion of the settlement funds.
On May 15, Dow Corning filed for bankruptcy protection but said it still
planned to honor the $2 billion commitment.

Rep. Traficant and the other representatives say the class action
plaintiffs "cannot wait years for compensation while Dow Corning ties up
the settlement in bankruptcy court"

In addition, they charge that Dow Chemical, a parent company of Dow
Corning, manipulated securities laws to deflect implant litigation. A
Federal judge has refused to exclude Dow Chemical from such litigation.
~~~~~~~~
By GLENN HESS
==========================================================
News Alert - breast implants

To: kathynye@...

MORE Than 8.7M Cosmetic Plastic Surgeries in 2003, Up 32 Pct. ...
U.S. Newswire (press release) - Washington,DC,USA

... - The number of breast augmentations increased seven percent from
2002
to 2003, even while the FDA debated the safety of silicone breast
implants
- a public ...

<http://releases.usnewswire.com/GetRelease.asp?id=123-03082004>

TV breast implant surgery revolts Italians
Telegraph.co.uk - London,England,UK

... The controversial show had already featured women before and after
receiving breast implants, with the newly-enhanced patients emerging
from
their operations ...

<http://www.telegraph.co.uk/news/main.jhtml?xml=/news/2004/02/29/wplas29.xml&sSh\
eet=/news/2004/02/29/ixworld.html>

BOTOX Could Be A Woman's Bosom Buddy

NBC5.com - Chicago,IL,USA

... Breast implants are the standard procedure for doing a breast lift.

Unlike implants, Botox can't change the size or shape of a woman's
breast.
...
<http://www.nbc5.com/health/2888632/detail.html>
======================================================
Subj: Anne Stansell's photos
Date: 3/8/2004 12:46:59 PM Eastern Standard Time

From: magal4@...

Sorry if I gave the impression that Anne's photos were on a web site.

Anne did not put them on one because she was afraid they would be
reproduced and used in an unauthorized manner.  A self photo of her
was
on CPR website at one time.  The same photo was on the front
of an issue of the newsletter from
SILICONE SURVIVORS OF THE WORLD when
that organization was active.  Anne presented her photos during her
speeches at different rallies in DC--some of you may have seen them.

I was just responding to the note from Ilena on 2/25 regarding an
article
in a newspaper about Anne and her photography.

Margaret  magal4@...

Funding Request Middleton - from the evidentiary files of breast implant
litigation
Thanks to Pam Dowd for sending the following from the evidentiary files
of breast implant litigation. . .Myrl
----
DCC017002825

DOW CORNING

July 1, 1992

Michael Middleton, M.D.
Department of Radiology
University of California
Medical Center
225 Dickinson Street
San Diego, CA 92103—8890

Dear Dr. Middleton:

This letter is a follow-up of our phone conversation of June 29, 1992. I
notified you in our conversation that Dow Corning has selected you and
Dr. Dobke to fund for further studies on MRI detection of breast implant
rupture. Our decision was based upon the submission that you made to the
Plastic Surgeons Educational Foundation (PSEF) in January of this year.
You notified me that you have already completed substantial work on the
project, and have made subsequent submissions to either Jim Curtis or
Bob Levier at Dow Corning. You also informed me that you have had
subsequent conversations with these parties in which you have requested
not only funding of the research, but, funding of your salary for the
upcoming year. I have not yet spoken to either Mr. Curtis or Dr. LeVier
and do not know what commitments they may or may not have made. I want
to confirm my statements on the phone that I am not willing at this time
to make any commitment on salary.

P1ease submit a new proposal and protocol for your intended work. I
understand that you have a two month extension on your current
fellowship, and we will move quickly to come to a decision on your
proposal so that you know exactly what financial commitment Dow Corning
will make.

Sincerely yours,

Myron C. Harrison, M.D.
Corporate Medical Director
(517)   496-6945
MCH/dmk

cc: Ralph Cook
Robert LeVier
Jim Curtis
Dr. Mark Dobke

DC Denies Funding for Registry/Study - from the evidentiary files of
breast implant litigation

Thanks to Pam Dowd for sending the following from the evidentiary files
of breast implant litigation. . .Myrl
---
DCC017002756

DOW CORNING

September 29, 1992

John A. Pierce, M.D.
Northwest Breast Center
1845 West Orange Grove Road
Building #3
Tucson, AZ 85704

Dear Dr. Pierce:

Your September 1st letter to Gene Jakubczak requesting financial support
for a breast implant registry and study was forwarded to me.

What you propose is quite ambitious and, based upon your budget
estimates, very cost effective; however, at this time, we respectfully
decline the opportunity to fund your project. I believe the
communications component of your proposal (part 2) will be addressed by
the national registry that is being developed in cooperation with the
FDA. We are also currently funding a number of studies that address the
issue, of post-operative complications and the detection of breast
cancer (parts 3—5).

While we will not be funding your project,
I do appreciate your willingness to develop and disseminate information
that may be of benefit to women with breast implants.

Sincerely,

Ralph R. Cook, M.D.
Director of Epidemiology
(517) 496—8772
RRC/tme

cc: Gene Jakubczak
Myron Harrison, M.D.
Robert LeVier, Ph.D.

Synthetic Science

http://www.alternet.org/story.html?StoryID=17933

By Lila Rajiva, AlterNet

February 24, 2004

"It's only salt water," says the surgeon flapping the translucent
rubbery disk. "If it bursts, it gets absorbed into your blood.

The only problem is capsular contracture and I've seen that only once
and she was someone else's patient."

The tired-looking woman in her thirties asks doubtfully if there are any
other serious issues. "No," he says breezily, "all you have to think
about is how you want to look. I'll take care of the rest."

A week before surgery and with the non-refundable down payment already
made, a thirty-page consent form filled with technical jargon is handed
to her to sign. There is no time to study it in great detail, no
explanations given, no videotapes shown of the procedures.

"That's just for the lawyers," says the surgeon as she hesitates. "Look,
anything can be fatal," he adds. "There are more chances of your driving
round the corner and being killed." She signs.

Missing from this conversation, a paraphrase of the experience of one of
about 300,000 women who undergo breast augmentation every year in
America, was any reference to the findings of the most recent and
extensive studies of implants that show that not only silicone but
saline implants, widely regarded as safe, are health hazards.

Early this February, after an advisory panel recommended that the ban be
reinvestigated, the FDA upheld the ban on silicone implants saying that
more research was necessary to prove their safety. The original ban went
into effect in 1991 following a public storm over implants fuelled
partly by a 1990 CNN
Face To Face with Connie Chung that showed leaking silicone gel
poisoning the immune system, causing crippling arthritis, skin lesions,
and horrific disfigurements. The dangers of saline, which are less
documented but equally worrisome, include bacterial contamination and
hardening and deflation, leading to more surgery.

After the 1991 ban against silicone, 400,000 women pressed damages
against manufacturer Dow Corning in a class action suit so extensive
that Dow finally agreed to settle for over $4 billon. Aware that its
long-term viability was in question, the company launched one of the
most effective PR campaigns in history steered by DC-based
Burson-Marsteller, the world's largest PR firm and the folks responsible
for making over both the tobacco industry and Union Carbide.

How effective this campaign was can be deduced from the fact that within
a few years the evidence against implants was being regarded as the
epitome of "junk science." In an interview in February, 1996 with
Frontline, Marcie Angell, editor of the prestigious New England Journal
of Medicine and author of a 1996 book called "Science on Trial: The
Clash of Medical Evidence and the Law in the Breast Implant Case,"
claimed that a number of studies proved that there was no scientific
link between implants and cancer or autoimmune disease. The implication
was that hysterical women instigated by lawyers salivating for
multi-million dollar fees were storming the Olympian citadels of
medicine with junk claims.

However, the research Angell cited to support her contention was
actually a better candidate for the term "junk" than what she attacked.
It was also more insidious because it carried the imprimatur of
prestigious institutions like Harvard and Mayo. What casual readers
could not know was that the 1994 Harvard study, like the others she
cited, was damningly flawed in several ways:

The sample size of 1,183 women was too
small to study such rare diseases, included women with very recent
implants (even one month), did not include women with ruptured implants,
and followed the women for 9.9 years on average. Since most serious
diseases that could be caused by silicone exposure would most likely
develop several years after a rupture (and ruptures tend to happen after
7-12 years), the study was almost set up for diseases not to show up.

Astoundingly, none of the women was actually examined in person. The
findings were all based on questionnaires and records.

Only classic autoimmune disease symptoms were evaluated whereas silicone
poisoning, a new disease, manifests atypical ones.

Finally, two of the authors admitted under threat of perjury that they
were paid consultants of implant manufacturers and one admitted under
oath that he knew that Dow Corning had donated $7 million to Brigham &
Women's Hospital, a participant in the study.

Nor was this the only time the saintly NEJM had been surprised in bed
with corporations. In 1996, the Journal ran an editorial claiming the
benefits of diet drugs outweighed the risks without informing readers
that the authors were paid consultants for companies that made or
marketed one of those drugs, Redux, banned by the FDA in 1997. In
November, 1997 it let the medical director of W.R. Grace and Co., a
known chemical industry polluter, write a review panning a book linking
environmental chemicals to higher rates of cancer. And the Journal
itself concluded in a 1998 study that authors with ties to corporations
invariably acted as shills.

The implant studies follow this pattern:

The two Mayo clinic studies were partially funded by the American
Society of Plastic and Reconstructive Surgeon and indirectly by
manufacturers, and other studies by Emory University and Michigan were
funded directly by Dow. In fact, Dow's general counsel bluntly stated
that no studies were conducted without considering their impact on the
implant litigation. Even so, the authors of these studies themselves
conceded that the absence of proof of a link was not to be taken as the
proof of absence of a link. But that was drowned in the PR sound and
fury.

Playing into the academic need for publications and conferences,
Burson-Marsteller used ghost writers to co-author articles for journals,
paid well-known professors to present evidence at meetings subject to
none of the peer review standards of academic conferences, and was able
to get questionable "positive" evidence front-page attention while
negative results were buried inside the papers. When a larger study by
Dow showed a 45-59 percent increased risk of rheumatoid arthritis, it
was abandoned midstream and never publicized. Also undisclosed were
memos that showed that Dow Chemical, the creators of Agent Orange and
napalm, had known since the 1940's that liquid silicone could migrate to
the brain, lungs, and liver, and damage the nerves and immune system.
Since its subsidiary had been marketing the gel implants as safe for
twenty years, this cover-up by the parent company resulted in punitive
damages of $14.2 million for the company's role in the poisoning that
resulted in brain lesions and permanent disability for plaintiff
Charlotte Mahlum in 1995.

In 2001, when the National Cancer Institute presented its study of
13,500 women who had implants for at least 8 years, the most thorough to
date, it was subjected to a media nip-and-tuck operation. Excerpts were
speciously highlighted to create the illusion of a vindication of
implants though the actual findings were quite disturbing. True,
implants were not linked with most cancers, but both saline and silicone
were associated with 2-3 times higher rates of brain cancer, 3 times
higher rates of lung cancer, and 4-5 times higher rates of suicide.
Another NCI study found a 21% overall increased risk of cancer for women
with implants adding cervical cancer, leukemia, stomach, and vulvar
cancer to the other risks which include higher incidence of
fibromyalgia.

While these studies did not establish a causal link, always an extremely
difficult proposition, they are surely alarming enough to warrant a hold
on all implant sales. In professional journals such as The Journal of
Aesthetic Plastic Surgery,

The American Journal of Clinical Pathology, The Journal of the American
Medical Association, Arthritis & Rheumatism, and The Archives of
Pathology and Laboratory Medicine, physicians have voiced their strong
concerns.

Yet in the public arena, exactly the opposite view has been prevailing
thanks to Dow's stunning success in deploying "astro-turf" lobbying by
phony citizen groups like Y-Me, funded by Dow, Bristol Myers Squibb, and
Plastic Surgeons Associated and the reassuring "Nicole" pro-implant
website that popped up ubiquitously when women tried to research
implants and also funded partially by plastic surgeons. Like the
surgeons' websites – which rarely present any sharply negative images
and portrayed the whole operation in slick, glossy pictures – it was
little more than an advertisement to lure unwary consumers.

Although they are required to, few doctors show patients the FDA site
that presents photos of the serious disfigurements possible. Meanwhile,
scholars like Michael Fumento of the conservative Hudson Institute,
which receives agribusiness funding, likened the anti-implant evidence
to snake oil and dismissed capsular contraction as a "minor problem"
though contracture, a serious problem in 20% of cases, can even in
milder forms make the breast hard as a football. In extreme cases, pain
is so severe as to demand immediate surgery.

Like Fumento, Citizens Against Law Suit Abuse, another corporate citizen
group (funded by big tobacco, health insurance companies, and Dow) and
Advancement of Sound Science Coalition (also Dow funded) beat their
synthetic breasts over the scourge of frivolous suits based on
fraudulent science but the truth is product liability and medical
malpractice cases amounted to only 2% and 4.4% of civil cases in 1996;
the bulk of frivolous suits are in fact pursued by businesses against
other businesses.

The libertarian Cato Institute, which dubbed the 90's the age of junk
science and lumped implants in with alar and dioxins as a scare tactic
of the anti-business flat-earth society left, airbrushed Dow into a
martyr. By 1995 when it filed bankruptcy, the company had conveniently
whittled down the claims against it by more than a billion dollars.

As its CEO told shareholders, Dow was actually having its most
profitable quarter and the Chapter 11 filing was simply a strategy to
get on with business. The extent of Dow's rehabilitation was shown by
the fact that saline implants were approved in May, 2000 followed in a
narrow vote by silicone in October,
2003. The decision was a shocking display of the incest between
government regulators and the industries they regulate, for four out of
the nine voting members were themselves plastic surgeons.

In this context, the FDA's February 8 reversal reinstating the silicone
ban is a welcome decision, but doesn't address the question of saline
implants. Although they were not studied separately, they were also a
part of the Cancer Institute study.

Saline has a shelf life and once sterility is lost has the potential for
contamination by fungus and bacteria that can then cause systemic
infections. It also has about a thirty percent chance of deflation in
the first ten years, a much higher rate than silicone.

Dr. Diana Zuckerman of the National Center for Policy Research for Women
& Families (www.center4policy.org), a critic of the saline implants,
points out that once approval is given, manufacturers have no incentive
to improve the devices, women gain an unwarranted sense of security, and
the FDA itself retains little ability to check if its guidelines are
being followed.

She points out that long-term effects aside, local problems are
extensive and severe. For example, one recent manufacturer study itself
showed that during the first five years of having saline implants, 45
percent of breast cancer reconstruction patients required additional
unplanned surgery, 28 percent had their implants removed, 36 percent had
capsular contracture, 18 percent had implants that had moved to the
wrong place, 18 percent had breast pain, and 8 percent had implants that
leaked or deflated. The rates of 10 other complications such as
infections, tissue death and implants poking through the skin ranged
from 3 percent to 7 percent each. And these are only the results at five
years when most implants have not deteriorated. Deflation and rupture
caused by wear and tear, breast trauma, undetected damage or shell
weakness are further significant complications; one study found that 70%
of removed implants 11 to 15 years old were ruptured or leaking. When
the filling is silicone gel, the silicone can migrate to other parts of
the body, cause reactions, and be difficult or impossible to remove
while the saline if contaminated can cause systemic illness.

All this is besides so-called "cosmetic" complications such as
alterations in shape or volume of the breast, mammography interference,
chest pain and nipple discharge.

Neither the original surgery or most complications are covered under
insurance, so many implanted women end up spending tens of thousands of
dollars.

Although experts like Dr. Neil Rose of Johns Hopkins University state
that typical autoimmune disease is unconnected to implants and just
naturally much more widespread in middle aged women than previously
suspected, until controlled studies are conducted of 10-20 years in
length for a sizeable population, all such conclusions are likely to be
premature. Right now, implanted women are simply guinea pigs. Both types
of implants need much more study before being used in women.

Dow's strategy has only succeeded because it has managed to appropriate
the language of self-empowerment and present the ban as an assault on
women's autonomy whereas plastic surgeons who have been systemically
undermining women's autonomy by pushing to label quite normal variations
in breast size and appearance as deformities in need of surgical
correction, using terms like hypomastia for small breasts. If women's
choice were being empowered, surgeons would also spend more time
offering alternatives such as lift surgery or suction cups, which have
had some success. But both these are one-time remedies whereas
implantation offers the surgeon the potential for repeat surgery, can be
performed quickly by a specialist, and permits a sizeable profit off the
sale of each implant. In other words, implants are a moneymaking hustle
in which, since the risks are still unknown even to the experts, the
informed consent of the patient is frankly inoperative.

In any case, cosmetic surgery that presents itself as a commodity open
to the consumer's rational choice like any other forgets that surgeons
are not vendors like car salesmen but trustees of their patient's
health. And when the science that is supposed to guide them
dispassionately in their trusteeship is instead synthesized to
manipulate the patient, the contamination of patient trust and the
profession of medicine are likely to be as toxic as leaking silicone.
~~~~~~~~~
For links and studies, you are welcome to visit:
www.BreastImplantAwareness.org
www.BreastImplantInfo.org (Dr. Zuckerman's site)

From Myrl

MSNBC: Seeking better breast implants
(see photos on page)
Seeking better breast implants
Doctors experiment with 'gummy bear'
fillers, titanium coatings
Cohesive silicone gel implants, such as this one made by McGhan, a
division of Inamed, are designed to avoid leaks.
By Denise Mann
MSNBC contributor
http://msnbc.msn.com/id/3972625/
Updated: 6:50 p.m. ET Feb. 11, 2004Many women hoping for a more
natural-looking alternative to saline breast implants were disappointed
by the Food and Drug Administration's recent decision to maintain the
ban on silicone-gel-filled implants. But there may be other options on
the market one day, as doctors continue their quest to find better ways
to boost a woman's bosom.
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Among the most promising developments, they say, are cohesive silicone
gel, leak-resistant implants with the consistency of a gummy bear and a
new type of implant shell coating that may be less likely to cause
inflammation and scarring in the surrounding breast tissue.
"I think we are getting closer to developing the perfect implant, in
terms of durability, biocompatibility and natural shape," says Dr. Mark
Jewell, a plastic surgeon in Eugene, Ore., and vice president of the
American Society for Aesthetic Plastic Surgery.
Safety concerns linking ruptures of the silicone gel implants to
autoimmune problems in some women caused the FDA to ban the sale of the
implants in 1992, except for use in clinical trials and by women
undergoing breast reconstruction. While the implants were somewhat
exonerated by an Institute of Medicine report saying they do not up the
risk of autoimmune disease, the new FDA ban calls for more study before
they can be put back on the market.
'I think we are getting closer to developing the perfect implant, in
terms of durability, biocompatibility and natural shape.'
— Dr. Mark Jewell
American Society for Aesthetic Plastic Surgery
Both saline- and silicone-filled implants have a silicone shell. But if
the saline implants leak, deflate or rupture, which they often do, they
would release only salt water -- not silicone -- into the body. The
downside of the saline implants, though, is that they don't look and
feel as natural as the others.
"Some people are concerned about the safety of silicone gel and many
people are disappointed about the performance of saline implants,
notably that they are associated with more ripples, have a more liquid
feel and don't look as natural as the silicone implants," says Dr. Grant
Stevens, medical director of Marina Plastic Surgery Associates, with
locations in Marina Del Rey and Palos Verdes, Calif.
'Gummies'
Enter cohesive gel implants, which are currently on the market in Europe
and Brazil, and now being studied in the United States.
"The 'gummy bear' implants have the positive attributes of the silicone
gel, but lack the concerns of gel migration," says Stevens, who is one
of 15 U.S. doctors participating in a study of Silimed cohesive gel
implants.
Dr. William P. Adams, Jr., agrees. "The gel doesn't migrate, so there
are potential safety benefits because if the shell should fail, the gel
will not go anywhere -- it would just stay in one place," says Adams, an
associate professor of plastic surgery at the University of Texas
Southwestern Medical Center in Dallas.
And unlike saline implants, Stevens notes, "cohesive gel implants feel
like breast tissue, not a water balloon."
So far, he adds, the data and patient response are "overwhelmingly
positive."
INTERACTIVE
• Key events in the quest for a bigger bust line.
Last October, 42-year-old Charlie Sheridan, who works in Stevens'
office, traded in her saline implants for a pair of cohesive gel
implants as part of the clinical trial.
"I am sporting a pair of gummies," Sheridan says. "They have the look
and feel of silicone, but don't have the hardness or lack of naturalness
of saline and there is no worry of deflation," she says. One of her
saline implants did, in fact, deflate which is why she opted for the
newer model.
The companies Inamed and Mentor also are conducting studies of their
versions of the cohesive gel implants.
Experts in the field say it could be at least three to five years before
any such product is on the U.S. market, provided the FDA approves one.
But not all plastic surgeons are completely sold on these new implants.
"The problem is density," says Dr. Lawrence Reed, a New York City
plastic surgeon. "They may have value in reconstructive procedures
because you need density and mass, but for normal women, they are too
dense," he says.
"Cohesive gel is a refinement of the current silicone implant, but it's
harder than usual silicone gel, so it's not the total answer," agrees
Dr. Rod J. Rohrich, president of the American Society of Plastic
Surgeons and the chairman of the department of plastic surgery at the
University of Texas Southwestern Medical Center.
Another product in the pipeline, he notes, is an implant filler made
with a substance called polyethylene glycol.
"It contains a patented blend of polyethylene glycol and saline and
results in an implant that has the look and feel of silicone," says
Rohrich, who helped develop the substance.
Hopes for indestructible implants
Titanium-coated breast implants may also be an option in the future. The
product of a partnership between Poly Implants Prostheses, a French
company specializing in implants, and GfE, a German aerospace company,
Tibreeze implants are coated with a thin layer of titanium and filled
with silicone gel.
"It's not like you dip it in molten titanium, it's a thin coating that
bonds to the silicone," Jewell explains.
Alex Wong / Getty Images
During a hearing last October of an FDA advisory panel considering the
return of silicone gel implants, Erin Hiemstra and Beth Nichols of the
National Center for Policy Research for Women & Families hold
post-surgical photos of breasts with removed silicone implants.
----------------------------------------------
"Titanium is a more biocompatible metal than even stainless steel," he
says, meaning that it is less likely to cause a toxic or otherwise
injurious reactions in the body.
Researchers are hopeful that by coating the shell, the implant will be
more resistant to infection, stronger and will produce less scarring and
capsular contracture, a condition that occurs when scar tissue forms
around the implant and results in painful stiffness of the breast and
possible leakage of the substance inside the implant.
So far, Jewell says, three women have received the implants as part of a
clinical trial in Germany that began last year.
"We don't know yet if it will have a durability advantage," he adds.
Lunch-time breast lifts?
Women can get lunch-time injections of Botox and various facial fillers,
and now researchers in Sweden may have found a way to boost a woman's
breast size during the lunch hour as well.
In the near future, Rohrich says, injections of hyaluronic acid, a
compound used to fill fine lines and wrinkles, could be used to do
temporary breast enhancement.
"It is a non-surgical procedure and can be used to build up breast
tissue and enhance the breast for a couple of years," he says.
Currently the injections are being performed as part of pilot studies in
Sweden by the manufacturer, Q-Med. Enhancements, however, are not
permanent and eventually the hyaluronic acid will be re-absorbed into
the body.
Peering into his crystal ball, Rohrich forecasted what else may be on
the distant horizon, including grow-your-own breast implants.
"We may one day make our own implants from our own fat where surgeons
harvest fat via liposuction and stimulate it to grow," Rohrich says, "so
it will be natural but to grow that amount of fat and grow it
consistently may be years and years away."
Denise Mann is a health writer based in New York City.

Our Kacey talks about her breast implant fiasco

Date: 3/16/2004 10:01:22 AM Eastern Standard Time

From: ilena2000@...

To: kaceyalong@...

http://www.nypost.com/entertainment/20691.htm

NY POST:  Bravo ... Our Kacey talks about her breast implant fiasco

EXCERPT: Texas native Kacey Long, who is a subject on the show, didn't
want
to change her face but did want to look like Julia Roberts in "Erin
Brokovich" after noticing Roberts' enhanced bustline in that movie
(which
Roberts has said she got through push-up bras).

Long got a payment plan, and then she got breast implants for $4,500.

"I saw the movie and they taped her breasts up and I thought, 'Maybe
that is
more attractive,'" she says.

But since the implants, Long (now 21) had been incredibly ill, suffering
from a painful case of arthritis that causes constant exhaustion.

She had over $400 in medical bills per month.

MTV documented her breast implant removal procedure (which cost another
$6,000) and a few weeks of her recovery.

Long says plastic surgery is almost as common for high school and
college
kids as getting a pedicure.

"It's becoming socially acceptable, like, 'Oh I'm going to get my nose
done,'" she says. "And people act like it's no big deal."

FACE TIME
By FARRAH WEINSTEIN
------------------------------------------------------This 20-year-old
Arizona man wanted Brad Pitt's mug - so he went under the
knife to get it.

March 14, 2004 -- SHA Ross, who is just 19 years old, wants to look like
Pamela Anderson.

So she gets breast implants, lip implants and liposuction on her chin,
all so she can realize her dream - and her heroine's accomplishment - of
being a Playboy centerfold.

And guess what?

She got it. Jessica, a 23-year-old transsexual, idolizes Jennifer Lopez.
So
she is having breast implants, cheek implants, an eyebrow lift and her
hairline lowered so that she can look like her idol.

Jesse, an Elvis impersonator, wants to get a chin implant and lip
injections so he can look more like "The King."

And Mike and Matt, 20-year-old twin brothers from Arizona, want more
than
anything to look like Brad Pitt.

They both get rhinoplasty, chin implants and porcelain veneers, in the
hopes
that all the facial overhauling - and massive pain that they suffer -
will
ultimately help them with their dreams of becoming movie stars.

And all of these people undergo their surgeries on TV.

Beginning tomorrow night, MTV is airing "I Want a Famous Face," a new
reality show that makes the plastic surgery patients on "Extreme
Makeover" look like models of restraint.

Each of these subjects - who are in the throes of idol worship and some
serious self-esteem issues - are seen before, during, and after their
surgeries, while parents and friends cheer them on.

MTV insists that they are not exploiting young people with somewhat
fantastic dreams but are rather merely documenting a phenomenon that is
beginning to sweep the nation.

"The idea behind the series is to document trends we see with young
people," says supervising producer Marshall Eisen.

"A lot of them are interested in emulating a celebrity in some way," he
continues. "A big part of the culture has an obsession with celebrity,
and then there's an obsession with looking better, and the two are
intercepting in a way we can't ignore."

According to the American Society of Plastic Surgeons, more than 8.7
million
cosmetic plastic surgery procedures were performed in 2003, up 32
percent from nearly 6.6 million in 2002.

People ages 19-34 made up 26 percent of these cosmetic surgeries.

But does cosmetic surgery really make a person feel better on the
inside, or has America just gone berserk?

Dr. Garth Fisher, a plastic surgeon who is married to TV personality
Brooke Burke, says he frequently gets patients who bring in celebrity
photos and request Angelina Jolie's lips or Ashton Kutcher's eyes.

He thinks that "I Want a Famous Face" will be fun to watch - but, he
(somewhat obviously) is unsettled.

"I don't think you can make someone look exactly like somebody else. You
can't turn anybody into Brad Pitt."

And while the subjects on the MTV show may suspect such a thing, it
doesn't
deter them.

One subject, however, is documented as she makes the decision to reverse
her
plastic surgery after she was not only unsatisfied but suffered
enormously
afterward.

Texas native Kacey Long, who is a subject on the show, didn't want to
change her face but did want to look like

Julia Roberts in "Erin Brokovich" after
noticing Roberts' enhanced bustline in that movie (which Roberts has
said
she got through push-up bras).

Long got a payment plan, and then she got breast implants for $4,500.
"I saw the movie and they taped her breasts up and I thought, 'Maybe
that is
more attractive,'" she says.

But since the implants, Long (now 21) had been incredibly ill, suffering
from a painful case of arthritis that causes constant exhaustion.

She had over $400 in medical bills per month.

MTV documented her breast implant removal procedure (which cost another
$6,000) and a few weeks of her recovery.

Long says plastic surgery is almost as common for high school and
college
kids as getting a pedicure.

"It's becoming socially acceptable, like, 'Oh I'm going to get my nose
done,'" she says. "And people act like it's no big deal."

"We show how brutal the surgeries are, and how the results come out,"
says
producer Eisen. "Every [subject] says, 'why did I do this?'

The twins who want to look like Brad Pitt, he says, are self-professed
"ugly guys."

After multiple facial surgeries, they "didn't feel like they look like
Brad Pitt," Eisner says.

Dr. Larry Rosenthal, who performs one-day "smile makeovers" on
celebrities
like Matt Dillon and Bridget Hall, has an interesting philosophy.

"I don't think any of these shows are shockers," he says. "Reality shows
are
showing what is. It's people fantasizing to be someone else or something
else. They think if they look like that, they're going to be like that.

"It's not reality - it's fantasy more than anything else," he says.

While some plastic surgeons understand why young people increasingly
want to
look like celebrities - and think that it may improve their lives -
others people remain skeptical.

"If everyone wants to come face-to-face with the trainwreck of American
culture, this is where you can see it," says 32-year-old pop culture
omnivore and Gawker.com editor Choire Sicha. "When we were kids, we
dressed up like Madonna and went to the mall. We didn't do anything
irrevocable, like get our faces done."

Mary McDonough

Since I went public with my breast implant problems six years ago,
hundreds of women have contacted me desperate for trustworthy
information about breast implants. Like me, they underwent various
operations they were told were perfectly safe then had terrible
problems. To add insult to injury, they couldn't find out how to get
better.

I founded In the Know as a support group for women in the entertainment
industry who are struggling with these issues. It is essential that we
all get "in the know."

Over the years I have worked regularly with the brave women you see in
this room. These women have been courageous enough to publicly talk
about their problems with breast implants, some for years, some for the
first time today.

Sally, Leigh, Leanza, Christy, Judy –
everyone – we are all unfortunately "In the Know" about the harm
breast implants can do. That is why we have gathered here today.

In October, the FDA will hold meetings about lifting restrictions on the
sale of silicone gel breast implants. They are considering LESS THAN
THREE years of data.

Less than three years of data? This is absurd for a device women hope
will last a lifetime. All of the women here will tell you that their
problems began after three years - and many of their health issues got
much worse over time.

There's so much that we DON'T know about silicone gel breast implants -
but we do KNOW that most problems begin YEARS after implantation. I
started to have serious problems five years after my initial surgery.
Researchers and clinicians agree that problems begin, on average, at
seven to ten years post-implantation.

Let's look at what else we DO know.

We do know that breast implants do not last a lifetime. They all fall
apart in the body over time. When mine were removed, the outer lining
was completely missing and the gel was held in place by my own scar
tissue. According to the FDA's own research – at five years, most
implants are still intact. At ten years, many are ruptured. By fifteen
to twenty years, most are broken. Knowing this, the FDA is contradicting
its own research by looking at only two to three years of data when it
considers approval in October.

We do know that women have painful and debilitating complications in the
breast area. I had so much pain I could not hold or hug my own child.
Once again, according to the FDA's own consumer handbook, these problems
get much worse over time.

We do know that women with breast implants require many repeat
surgeries.

The New England Journal of Medicine said in 1997 that one in four women
need additional surgery within five years because of problems related to
their breast implants.

We do know that health insurance often does not pay for these repeat
surgeries or the replacement implants.

We do know that cancer survivors suffer at much higher rates from
painful complications and require more repeat surgeries.

We do know that hundreds of thousands of women have been hurt by breast
implants.

We do know that it's impossible to get a clean mammogram. Implants
obscure about 80 percent of breast tissue.

We do know that silicone gel escapes the implant and travels all over
the body.

We do NOT know the effect of silicone in the body.

Today you will hear from these women. Some of them only had a few
problems. Some of them got very, very sick. Their common denominator?
All of them were still fairly pleased with their implants two to three
years after augmentation and all had problems that developed over time.

When I contacted the FDA recently with my concerns, they sent me this
statement, "We will be able to give reasonable assurance of safety and
effectiveness."

What does that mean? It doesn't mean they are safe. What, exactly, is
reasonable assurance? Especially when the "reasonable assurance" is
coming from the very manufacturers who will make millions of dollars
from selling implants. How reasonable can their assurance really be?

If the FDA is going to put their seal of approval on silicone gel
implants, they need to be able to assure women that these implants will
not harm them. That they will NOT fall apart in the body, that they will
NOT turn as hard as rocks, that women will NOT suffer the rashes,
fevers, headaches, shootings pains and completely failed health you will
hear about today.

Let me make one thing clear – I am not ANTI-implant. I am PRO-safety
and information. This is our last chance to get something that works. If
we allow the FDA to lift restrictions on silicone, I fear we will NEVER
have a good, safe implant. FDA - please study the devices long enough to
assure women they are safe.

We are here today to ask the FDA to do its job. Protect women.


Linda Blair

I am sharing my breast implant nightmare publicly for the first time
today. Even though this is very personal and private, I must speak out.

No one ever warned me about the problems with breast implants. If the
FDA approves them, women will assume they are safe. They are not. I am
living proof. I was sick for years after I had my implants. Now that
they've been removed I am finally starting to feel better.

It's crazy for the U.S. FDA to let these be sold after looking at less
than three years of information. A lot of women are still happy with
their implants after a few years. Our problems start later and get worse
and worse as the years go on.
Isn't it the FDA's job to protect people from harmful food, drugs and
devices? I am joining my colleagues in the entertainment industry to ask
the FDA to do its job.

Remarks of Martha Burk, Chair, National Council of Women's Organizations

The National Council of Women's Organizations, the nation's oldest and
largest coalition of women's groups collectively representing over 8
million women, is pleased to join NOW, Breast Cancer Action, and others
represented here today, to urge HHS Secretary Thompson to stop the Food
and Drug Administration from harming another generation of American
women.

Breast implants constitute a huge and dangerous, uncontrolled experiment
performed on women's bodies. Over the last 40 years, several million
women have had implants without the FDA ever doing adequate research on
the risks and long-term effects associated with them.

Why have women been kept in the dark about the dangers of with breast
implantation? Because the FDA has failed to do adequate testing, the FDA
has failed to hold manufacturers to a rigorous standard, and above all,
the FDA has failed in safeguarding women's health.

Most likely we know moreabout treating baldness than we do about breast
implant surgery which is invasive, costly and associated with a range of
life-threatening side effects.

There's another reason we know so little about the long-term effects of
breast implants. Corporate America is in a rush to get silicone-gel
implants back on the market and cosmetic surgeons are eager to increase
their lucrative practices. This is a dangerous rush to judgment. The
National Council of Women's Organizations urges the FDA, charged with
protecting all consumers, to respect women's lives. We urge the FDA to
delay approval of breast implant products until the full picture on
their use, abuse, and side effects is known. Researchers stand at the
ready. The FDA needs to wait for the research and decide based on proof,
not profits.


Sybil Goldrich

I received silicone gel breast implants after a bilateral mastectomy. I
almost immediately developed a rash and a fever. It took over a year for
one of the incisions to seal up and heal. I could barely even stand up
because of the pain.

My left implant began to move down, away from the breast area, and my
right implant moved up.

My doctor assured me there was no problem with the implants. I had four
sets of implants in two years as we tried to "get it right." Through my
entire ordeal I had no idea the implants were causing the problem. I was
afraid I was having a cancer relapse.

When I finally decided to have the implants permanently removed, it took
the surgeon three hours to clean the silicone out of my chest. Once my
implants were removed I slowly began to recover.

Several years later, when I had a hysterectomy, silicone was found in my
uterus and ovaries. My liver looked odd, so it was biopsied. The biopsy
revealed silicone in my liver.

Cancer survivors are one of the favorite symbols in the debate over
silicone gel breast implants. We are repeatedly told that we must have
an option for women who have lost their breasts to cancer.

Yes, this is true. Women should have options for reconstruction. But
they should have safe options. As long as a flawed product is available
– and especially if it's available with FDA approval – we will never
have a safe implant.

There is no need for the FDA to approve silicone breast implants for
cancer survivors to get them. Women can already get silicone implants
after mastectomy without restriction. Saline implants were approved by
the FDA three years ago, so they are also available.


And most mastectomy patients are unaware of three very important issues:
Cancer survivors suffer from much higher complication rates than other
women.

Breast implants obscure mammography – nearly 80 percent of breast
tissue cannot be seen.

The National Cancer Institute found higher rates of certain cancer
deaths in one of the few studies that looked at longer-term health
effects.

Women deserve better. Tommy Thompson and Mark McClellan: do your jobs.
Protect American women.


Mariel Hemingway

I was 19 years old when I got breast implants. I'd been athletic and
healthy my whole life, but after having implants for a few years I
started to get sick all the time. I always had sinus problems and a
terrible rash on my hands.

I finally found out that the silicone implants had ruptured. My blood
stream was full of silicone. I had to go through long, painful
treatments to clean out my system. My breast cavity had to be scraped
clean. After getting them out, a blood test confirmed that silicone had
leaked into my blood.

These implants are bad news. The U.S. FDA can't get enough information
to tell women they are safe after only two years. I enjoyed them for a
year or two, then from ages 20 to 32, I was asking myself, 'Why do I
have these? I hate these.'


Christie Houser

For many years, I loved my silicone breast implants. They never got hard
on me and they looked great. But I started to have health problems four
years after I'd been augmented. At first, I didn't connect my problems
to my implants. But I kept having strange illnesses that wouldn't go
away and that got worse over the 10 years that I kept my implants in.

I had itchy, red rashes in various areas on my body. And when I went to
the dermatologist, they told me they didn't know exactly what they were.
They thought the rashes might be a sort of eczema, but the cortisone
creams prescribed to me would not make them go away.

My knees, ankles and hips started to ache. I would get really nauseas
and have to lay down at least once a week. It felt like I was coming
down with the flu - especially if I over exerted myself physically. I
remember one time I went for a run and collapsed beside a lake. A
stranger had to drive me home. This was very unusual for me because I
had always been very active and had competed in triathalons and 10Ks for
10 years previous to this.

I also became very sensitive to chemicals. I couldn't use hair spray,
perfume, fabric softener, or heavy detergents. I couldn't even walk down
the laundry detergent aisle in the grocery store because I would start
itching all over and my eyes would water like crazy. Towards the end of
the time I had my implants in, I had a terrible cough that wouldn't go
away, which continued for two years until I had them removed.

Finally, in 1993 I had an MRI. The technician said he felt something was
terribly wrong. My left implant was definitely ruptured and the right
one looked as though it might be also. I had the implants removed two
weeks later.

When they took them out, both of the outer shells had completely
dissolved.

They also found a golf ball-sized cyst filled with silicone behind the
left implant, which technicians were unable to detect with an ultrasound
and a mammogram before my MRI.

I didn't even realize how sick they had made me. Because it happened
gradually over a period of ten years, I felt that a lot of my symptoms
were from old age and motherhood. After the implants were removed my
rashes, allergies and joint aches all began to improve. I have no doubt
my health problems were a direct result of those ruptured implants. I
also have no doubt that the improvement in my health was a direct result
of those implants being removed from my body.

The U.S. FDA simply MUST consider more than two years of data before
they approve silicone implants back on the market. Women need to be more
informed and know what they are getting themselves into. I feel that it
is an insult to women, a huge slap in the face, not to study these
devices long enough to ensure their safety.


Arianna Huffington

I applaud the bravery of the women in the entertainment community who
are sharing their stories of pain and suffering because of silicone gel
breast implants.

This tale is a true tragedy of the modern age. These women were
completely assured of the implants' safety. Years later, when they began
to have problems, they were told it was all in their head.

They had to fight to get the information and treatment they needed to
get better.
But they persevered. Now they've made the long journey back to health
with little help from the medical and research community.

Why is the U.S. FDA ignoring their pain and the pain of hundreds of
thousands of other women by rushing to lift restrictions on the sale of
these devices? Is it because the silicone breast implant makers will
reap extraordinary profits from an approval?

If we know anything, we know that problems with silicone gel breast
implants often do not begin for years, in many cases over a decade. Yet
the FDA is considering less than three years of data for its decision.

Why are we having this rush to judgment now? Women can still get
silicone implants under clinical trials. Saline implants are available.

Even as the FDA plans hearings in early October, the countries in the
European Union are tightening their restrictions on the devices. Again,
why this rush to judgment?

These courageous women should not have suffered in vain. The U.S. FDA
must protect women and prevent history from repeating itself.


Kathy Keithley Johnston, R.N.
Executive Director
Toxic Discovery Network

My name is Kathy Keithley Johnston. I am the Executive Director of Toxic
Discovery located in Columbia, Missouri. I am a Registered Nurse, a
breast implant recipient and yet another undocumented, cover-up
statistic of breast implant device failure and illness.

I was implanted in 1984 with a second generation, low molecular weight
H/S silicone gel breast implant. I was implanted free of charge in
Midland, Texas. I was told when I was implanted that my breast implants
would last me a lifetime. The plastic surgeon was certainly correct.
They lasted me a lifetime of pain and suffering.

I was only 32 years of age when I received my implants. Within 2 months
after being implanted, I had sustained capsular contractures, low grade
temperature elevations, and chronic fatigue problems. Within one year
from implantation, I had been diagnosed with Raynaud's Phenomenon,
peripheral neuropathies, muscle pain and swelling of my joints. Ten
years after implantation, I would add to my symptoms and diagnoses, hair
loss, rashes and connective tissue disease.

Polydimethylsiloxane (silicone) that matched my breast implant material
was found in my spinal fluid during a lumbar puncture during testing for
multiple sclerosis.

In 1994, only ten short years after being implanted, I experienced a
documented rupture of my implants. I was explanted on March 31, 1994 and
elected not to be re-implanted. I was informed by a plastic surgeon in
Missouri that I was too ill to be re-implanted and saline was not an
option because of the silicone envelope. I lost my nursing position as
Director of Oncology, my trust in the medical profession and my faith in
humanity. I endured eight long years of litigation as an MDL 926 Opt-Out
and to date have never received one dollar from the breast implant
manufacturers.

Today, I stand in front of you as one of the "lucky ones". I have
endured years of immuno- suppressant drugs, chemotherapy treatments,
steroid prescription, and massive analgesics for chronic pain control
along with a plethora of other drug regimens to correct what breast
implants caused.

Yes, all of us here today are the lucky ones! Many of our sisters have
died from lupus, scleraderma, neurodiseases, and breast implant
complications and yes, even suicide.

The breast implant manufacturers and the plastic surgeons would like
you, the consumer, to continue to be "spoon-fed" their falsehoods that
breast implants are new and improved.

The breast implant manufactures and plastic surgeons would like you the
general public to believe that women who received breast implants for
the past 30 years are hysterical middle-aged women who because of our
so-called life-styles have injured our selves.

The breast implant manufactures and plastic surgeons would like you the
consumer to believe that this elective, non-lifesaving medical device is
safe and that it will give you instant self-esteem and make you more
attractive to your spouse and significant other's.

What the breast implant manufacturers and plastic surgeons do not what
you to know is that breast implants do rupture, they do cause harm and
they will need to be replaced several times during your lifetime. That
is IF you live a so-called life-time.

The young unsuspecting women of this world deserve a legacy. They
deserve a legacy of lifelong health, unlike the poor health that we here
today have endured from breast implant related complications.
The young women of this nation deserve to know the TRUTH! The truth is
as long as the "fox remains in the hen house" i.e. the plastic surgeons
and breast implant manufactures will continue to reap financial reward
from their unsuspecting victims – the legacy of breast implant fraud
will continue if we the victims do not demand and get accountability for
these unjust acts of chemical experimentation.
Informed consent does begin with informed individuals! We must demand
that the restrictions remain on all breast implants and we must demand
that the
FDA protect us from "female experimentation and mutilation." We must
finally demand a national registry. One that is free of malicious intent
and one that truly protects instead of hiding their heads in the
silicone. We must demand that our government finally takes steps in
protecting the women and their offspring from human chemical warfare.

We the breast implant women must no longer suffer in silence! We must no
longer tolerate the manufacturer's fraud, deceit and international
marketing cover-ups. We must no longer tolerate denial of proper medical
care for chemical induced diseases caused by greedy manufactures that
continue to blind the FDA to the truth that we endure daily.

We must stand united in the knowledge that "We Are the Evidence". We
must continue to fight to protect the next "unknowing" generation of
victims of breast implant cover-ups.

In closing I give you a quote from Jackson Browne, a famous songwriter,
musician and activist.

"How long can you hear someone crying?
How long can you hear someone dying?
Before you ask yourself why?"


Marlene Keeling
12615 Misty Valley
Houston, Tx. 77066

My name is Marlene Keeling. I chose to get double-lumen silicone
gel-filled breast implants in 1978 after checking with my Ob/Gyn, who
encouraged me without reservations so I assumed they were safe.
My plastic surgeon assured me only 2% of his patients ever had problems
and he could fix anything that happened. I trusted my doctor's opinions
because they had taken an oath to "do no harm". I trusted that no
manufacturer would make a product that they knew could cause harm.

I trusted the FDA was protecting me as a consumer. I trusted too much.

I developed problems immediately. My breast turned black and blue.
Within two days of my initial surgery, I had to have repeat surgery to
repair a hematoma.

Within eighteen months, my surgeon suggested a third surgery to release
the scar capsule after he was unable to break it up by pounding on my
chest.

My health problems did not start until about seven years after my
surgery. I noticed weakness and was unable to stand for long periods on
my feet without getting extremely tired. I had swollen lymph nodes in my
neck periodically. I became depressed and had no energy. In 1993, I
developed endometrial cancer and had a hysterectomy. I developed
short-term memory problems and other cognitive problems so severe that I
became a social "hermit". I was diagnosed with peripheral and
demyelinating neuropathy and had my ruptured implants removed in 1994.
It was a silent rupture. I don't know when it happened. All of my
symptoms have slowly improved and I no longer suffer from depression
since my implants have been removed. However, the last time I had my
natural killer cells counted they were low. Are breast cancer survivors
being told that the Institute of Medicine concluded that quote -

"consistent with animal toxicology studies it appears that natural
killer cells might be effected by exposure to silicone gel, since
removal of silicone breast implants was followed by an increase in
NK-cell function in 50% of women?" - endquote.

In networking with other silicone implanted women, I realized that many
were also being diagnosed with chronic inflammatory demyelinating
polyneuropathy and had memory problems or depression. In 1996, I became
a Founding Director of Chemically Associated Neurological Disorders
dedicated to information and research. A research project was started
with Ernest Lykissa, Ph.D., a forensic toxicologist as the principal
investigator.

Initially at Baylor College of Medicine, the research continued later at
ExperTox, Inc. In September 2000 we submitted the results to the FDA.
Eight out of the first eight gel-filled breast implants we tested
(including mine) released significant platinum in a reactive valence. If
platinum is in a free highly oxidizing form, the higher the valence the
more toxic and hypersensitizing the platinum becomes.

Five out of the first eight implants tested released platinum as high as
6+.

Fortunately for me, mine only released platinum as high as 4+ however
platinum with a valence of 2+ and 4+ render the platinum easily
transportable across the blood brain barrier.

Court stamped documents of proprietary information indicate
Chloroplatinic Acid or Dow 3-8015 INT (PLATNM2) was used in making
breast implants. Dow notified in 1996 the EPA Office of Pollution
Prevention and Toxics of substantial risk to Dow 3-8015 INTERMEDIATE
(PLATINUM #2). The FDA is unable to tell me if Dow Intermediate Platinum
#2 is used in the current implants under review because they say that is
proprietary information. Chloroplatinic acid is one of the most
hyper-sensitizing agents known to man. Scientific evidence has
demonstrated that platinum salts causes an inhibitory effect on brain
enzymes and causes structural damage to brain cells according to Dr.
Michael Harbut, Chief, Center for Occupational and Environmental
Medicine who has treated aver 1,000 breast implanted patients.

CANDO's research project continued. We collected hair, nails, sweat,
blood, and urine from the women whose explants had been tested for
platinum release. We also tested samples from children born to these
women before and after implantation. Significant amounts of platinum
were found in these samples but not in the children born prior to
implantation or in the control group (e.g. women without breast
implants). Dr. Lykissa has since tested samples of breast-milk, fat
tissue, muscle tissue, nerve tissue, and bone marrow from implanted or
explanted women. The media recently reported that medical devices use 3
tons of platinum a year.

Susan Maharaj, Ph.D. is the lead author of a research paper titled
"Platinum concentration in silicone breast implant material and
corresponding connective tissue by ICP-MS". This research found very
high levels of platinum in the first fifteen implants and corresponding
connective tissue that were tested at another laboratory and research
center.

Preliminary data from the National Institute of Environmental Health
Sciences (NIEHS) research project suggest, "Silicone may promote the
development of atypical forms of systemic connective tissue disease." A
study published by the Food and Drug Administration has shown women
exposed to "extra capsular silicone" gel escaping beyond the scar
capsule that forms around breast implants were at higher risk for
fibromyalgia. Dr. Arthur Brawer, board certified in both Rheumatology
and Internal Medicine, believes platinum may be only one of a dozen
mechanisms that may cause systemic disease in breast-implanted women.

German research published in January 2003 found high platinum levels in
the fibrin layer and fat tissue of two patients with prostheses. The
researchers state in this paper "the data of this work clearly show that
the use of elemental silicon as an indicator of migration from breast
implants to the surrounding tissue is not appropriate." In the Dow
funded study of breast-milk from implanted women, elemental silicon was
measured in an attempt to determine safety. The German researchers
confirmed to me that this is an inappropriate measure for breast-milk to
determine safety. The FDA states "It is not known if a small amount of
silicone may pass from the silicone shell of an implant into breast
milk. If this occurs, it is not known what effect it may have on the
nursing infant" We must demand more and better independent research. The
stakes are too high for our future generations.

Inamed on their web site makes the following statement: "A woman with
breast implants who has questions about risks while pregnant or breast
feeding should consult her physician." If the toxic and hypersensitizing
chemicals contained in breast implants are proprietary information known
only to the manufacturers and the FDA – how can a physician advise a
pregnant woman with implants regarding the safety of breast-feeding?

McGhan Medical (now Inamed) filed a patent in 2001 which makes the
statement "adverse medical consequences have recently become associated
with the use of silicone gel filled implants because it has been
discovered that the silicone oil can migrate through the implant shell
and the silicone oil is not biocompatible with other human tissues.
Therefore, the use of silicone based filler materials has been
discontinued in the industry." In a 2001 press release Inamed revealed
"the potential for reduced silicone migration of Cohesil gel in the
event of implant rupture (of their style 410 implant) remains to be
established."

Inamed makes this fraudulent statement regarding cancer risk on their
website "At this time, there is no scientific evidence that women with
silicone filled breast implants are more susceptible to cancer than
other women." NIH published research found significant increased rates
of brain and lung cancer among breast implanted women as well as
suicide. A second study confirmed the increased lung cancer and suicide
rates and now, a third study confirms the high suicide rates.
The results on cancer risk from a Canadian Breast Implant Study of
40,000 breast-implanted women should be available by the end of this
month.

I submit the Nuremberg code states "the voluntary consent of the human
subject is absolutely essential. This means that the person involved
should be able to exercise free power of choice, without the
intervention of any element of force, fraud, deceit, duress,
over-reaching, or other ulterior form of constraint or coercion; and
should have sufficient knowledge and comprehension of the element of the
subject matter involved as to enable her to make and understanding and
enlightened decision. During the course of the experiment the scientist
in charge must be prepared to terminate the experiment at any stage, if
he has probable cause to believe, in the exercise of the good faith,
superior skill, and careful judgment required of him, that a
continuation of the experiment is likely to result in injury,
disability, or death to the experimental subject. I say loud and clear
"FDA stop this experimentation on women and our future generations".


Mary Kinnunan

When I think of how silicone breast implants affect me, I¹ve got to
back to Parents Day, 1979, my junior year at Michigan. Standing next to
me on the corner of State and Liberty was a student my age, and her
mother, who was dressed very fashionably, in skin tight jeans, a tight
sweater, liver colored lips and cheeks #150; this is 1979 remember. Both
mom and daughter radiated wealth; rich suburbanites I thought.

And then I noticed the mother¹s face, how her skin had been stretched
back. It was the first time I¹d ever seen a facelift. And I thought
Wow.

That moment would become a defining one in my life. I thought of my
mother, 59 years old, happily teaching her classes, going gray, loving
my father, aging and comfortable in her own skin. How proud I was of her
for that.

Fast forward to 2001. At breakfast, my 17 year old daughter casually
announces she wants to get breast implants. Wow! I didn¹t know a whole
lot about them, so we did some research, and what we found scared the
hell out of me.

Implants present serious health and financial risks. But what really
scared me was that Eleanor is a rebel, and if a rebel is feeling the
pressure to increase her bust size, how much pressure are all the other
young women her age feeling?

Then I found out that the number of cosmetic breast implants has risen
626% in the past 10 years to 237,000 surgeries in 2002.

Wow!

I searched for a cultural response to the implant boom, and found some
good academic information from organizations such as those sponsoring
this rally. But nothing addressing the issue as the pop culture
phenomenon it is.

So Valentine¹s Day we launched tit4tat.net. Our message is ³no
silicone, no saline, no sir! – NICE TITS.² We¹re laying it on the
line that a women¹s natural assets are wonderful! A-B-C-D –
they¹re all good!

You know Inamed Corp¹s website says their implants give us women the
curves we¹ve always wanted. Sorry Inamed, but we don¹t need your
sacks of silicone.

We¹re happy with the curves we¹ve got. In fact, we love our curves
– whatever their size – because they are a part of our identity,
passed to us from the women who came before us – and to those who will
come after us.

We are women who want to send this message to our daughters: That a
women¹s self esteem and confidence are not bought with breast
implants, but earned through achievement. And to our sons we say that a
woman¹s beauty is not based on manufactured fantasy but on her natural
beauty, inside and out.

As for my daughter, she¹s not getting implants. She¹s learning to
play guitar and attending college to boost her self esteem and
confidence – and we¹re hoping get a good job. I¹m awfully proud of
her decision.

And I hope later this month we can be proud of our FDA: That they will
remember their first duty is to protect the public¹s health – and
that includes Women¹s Health, and to reject Inamed¹s fast track
Silicone Breast Implant
Approval.

Just as we reject the breast implant media hype and the mercenary breast
implant industry that puts their bottom line before women¹s health!


Sally Kirkland

I first got silicone gel breast implants in 1986. Three years later, I
began to have health problems which got progressively worse the longer I
had the implants.

Before I had them removed, I was in crippling pain, particularly in my
arms, chest, back and neck. I had shooting pains down my legs. I had
constant infections and inflammations. I was always sick with viruses.
Over the years I was diagnosed with Epstein-Barr, rheumatoid arthritis,
borderline MS and borderline Hepatitis. I went from being a Yoga master
and aerobics instructor to a very ill woman – at a very young age.

I had the silicone implants taken out and replaced with saline in 1995.
After several unsuccessful saline surgeries, I had the saline implants
removed in 1998. When the silicone implants were removed, there was
silicone all over my body - in my blood, joints and organs. I literally
saw test tubes of my blood that looked like it had glue in it. The
silicone was causing me terrible joint pain and preventing my organs
from working correctly. My pancreas, gall bladder and kidneys were not
functioning properly.

Since being explanted in 1998, the inflammation has miraculously
improved.

But I still have silicone in my system. I undergo constant treatments to
detoxify myself and boost my immune system.

The FDA should NOT remove restrictions from the sale of silicone gel
breast implants, especially after reviewing less than three years of
data. I didn't get sick until 1989 – three years after having implants
– and continued to get sicker every year after that. The FDA should
protect American women. No one should have to live through the nightmare
I've been through and continue to endure.


Judy Norton

When I got breast implants in 1983, I was never warned of any possible
side effects. A lot of women were getting them and I assumed they were
safe.

It was nearly eleven years before I began to notice problems related to
the implants. I was concerned about scar tissue which had thickened and
become much harder.

It even hurt to wear clothes that were tight across the scar tissue. I
was also planning to start a family and I was concerned about being able
to safely breast feed, without pain or danger to the baby's health.

Many women got a lot sicker than I did. But I wish I'd been told more
about the potential health dangers and pain before I got them.

The FDA needs to look at more than three years of data - my problems
didn't start for over a decade. Failing to properly evaluate product
safety will allow companies to continue to place this unhealthy product
in women's bodies, rather than working to create a better, safer
implant.


Cherry Schaver

My name is Cherry A. Schaver. I live in Santa Fe, Texas and I am a
silicone survivor! In March of 1982, I had a fatty tumor removed from my
right breast. Two months later, I had another fatty tumor right above
where the previous tumor had been removed. Because of fibercystic
disease producing these fatty tumors, I was told that I had a 97% risk
for breast cancer by my general surgeon. He recommended me to go to a
plastic surgeon. I had a double modified radical mastectomy in Sept.
1982. My breast tissue was replaced with Cappozzi polyurethane silicone
implants under my chest muscles on top of my rib cage.

In October of 1982, I had a fistula on the right breast and went into
shock. In November of 1982, I had the implant removed and it was found
that the fistula went all the way to the breast implant.

Drains were put in place and I was without a right breast implant for 3
months. Then I had another implant put in with a muscle-scarring band
across the implant. In 1985 I had the implant removed. The
muscle-scarring band was released and the same implant was put back in.
In 1988, the muscle-scarring had come back on the right breast.

I was diagnosed with iritis in 1988 and continued having problems until
1992. In March of 1992 my implants were removed. 6 months after they
were removed, I never had iritis again. In 1993,

I had a nerve and muscle biopsy done and was diagnosed with
demyelinating poly-neuropathy and suffering from muscle loss. I also had
a brain scan done, which showed brain loss on both sides.

In 1993 I had a cervical disk removed and am suffering from degenerative
disk diseases and had another cervical disk rupture in 2002. In May of
2002, I was sent to a environmental pulmonary specialist by my
neurologist. I had on MRI and a cat-scan done on my lungs and was found
to have a spot on the left lower lobe and a spot on the front of the
left lung near the breastbone. The specialist had MRIs and cat scans
performed again and the spots were reducing in size. The last cat-scan
in January in 2003 showed that one had left a scar and the other had
calcified.


Anne Stansell

In 1987 the doctors said, "You have breast cancer. You need a
mastectomy, radiation therapy and silicone breast implants", as if it
was ALL part of the treatment. The truth is, I did not need breast
implants to get over cancer. They did NOT tell me that silicone breast
implants were not , and never have been, approved by the FDA.

They did NOT tell me that there was an absence of research on the
effects of silicone breast implants in cancer survivors.

You see, I trusted the doctors whom, I felt, had just saved my life. I
thought they had my best interests in mind. I did not realize that my
plastic surgeon was probably thinking of making his next car payment
with the proceeds from my breast implant surgery. Little did I know that
with all the follow-up surgeries from all the complications, I probably
helped him completely pay off his new Mercedes.

They did not tell me there was a big chance for implant rupture and that
I was signing on for a lifetime of multiple surgeries due to implant
complications.

I've lost track of the number of major surgeries I've suffered before I
finally convinced the doctors to remove the silicone breast implants
completely.

They also did not tell me I'd get symptoms of auto-immune disorders.
They should have told me there'd be a big chance of getting pain in my
muscles and joints, fatigue, Graves disease, and dry eyes to the point
that the retina in my right eye tore.

But, my purpose in speaking to you today is to point out the absurdity
of it all!

The FDA placed a moratorium on silicone breast implants I in 1992, in
order to obtain evidence of long-term effects.

NOW, the FDA is considering approving silicone breast implants with only
a two to three years of study. And it should be noted that this research
has been paid for by the very same manufacturer now applying for
approval.

By the way, in the past, when a manufacturer did its own research, we
found that women who experienced complications with their implants were
dropped from the study.

This short term study stands a chance of being accepted as REAL science
by the FDA. This is the same FDA that has done its own research into the
durability of silicone breast implants, which showed that silicone
breast implants rupture at the alarming rate of 50% within ten years and
75% within twenty.

Silicone injections have long ago been banned by the FDA. Now, By their
own study, the FDA has their own accepted rupture rate of silicone
breast implants.

When an implant ruptures and silicone flows freely to all major organs,
I ask you what is the difference? What is the difference between a
ruptured silicone breast implant and a silicone injection?

As most of you know there is a silicone breast implant class action law
suit STILL pending. The women in this action have received nothing from
the Dow-Corning Corp. Recently, the federal government entered a lawsuit
to recover money it spent for women on Medicare, Medicaid and those in
our military who have been injured by silicone breast implants. The US
government was awarded $9.8 million for those medical expenses. That is
the same federal government that is now considering the approval of
silicone breast implants.

A couple of years ago, the FDA went through a similar approval process
for saline filled breast implants. At that time, the FDA approved
saline-filled breast implants for 2 corporations (again with only two
year studies bought and paid for by the manufacturers). One of those
manufacturers, the Mentor Corp was at that same time, under criminal
investigation by the federal government for its questionable
manufacturing practices regarding silicone breast implants. Senator
Edward Kennedy of Massachusetts wrote a letter asking the FDA for an
explanation. This is the same Mentor Corp that will also be addressing
and attempting to influence the FDA at next week's hearing.

ALL these contradictions come from the government agency that is
supposed to watch out for our health. We must STOP the FDA from
instilling a false confidence in the minds of millions of women
worldwide, in a faulty medical device based on a limited study with less
than three years of data. A study that has been bought and paid for by
the company that stands to derive great financial gain.


Leigh Taylor Young

I had silicone gel breast implants for over
ten years before I began having problems with them. Then I started to
notice that my breasts were getting hard, painful and, a little later, I
had problems raising my right arm.

I had the implants replaced. It took the doctor over three hours just to
scrape the calcification and scar tissue out of my chest. My left breast
would not heal from surgery. I then received a third implant in my left
breast. Within one month, I had severe pain that wrapped around my
breast and ran down my back. The pain was so intense that, if it
happened while I was driving, I would have to pull the car off the road.
It literally hurt to breathe. Soon it became difficult for me to lift my
left arm.

I finally decided to have the implants permanently removed. After this
surgery, I began to lose mobility in both of my arms and was in constant
pain whether I was moved or was still. I couldn't raise them more than a
foot from my sides. It took almost a year to regain full use. In some of
those months, I needed full time care to eat, dress myself or drive.

I spent a minimum of $70,000 (probably more) in care and treatment, and
all of my time getting better. None of the repeat surgeries or
treatments was covered by insurance. I was often unsure whether I would
succeed and recover, as there was no information readily available to
explain, diagnose or treat my condition. Today, I can gratefully say
that I have come to full restored health. To me it is a miracle given
the odds and the lack of information.

There is no question that I answer and account for my own choices. In
the soul searching I have done, I am clear that all women can and will
benefit from MUCH MORE information regarding the ramifications over time
of the presence of silicone in the human body. Thousands of women have
already been harmed by implants and millions more could be harmed if
restrictions are lifted now, and more years of extended study are not
implemented.

I'm joining my colleagues in the entertainment community to call on the
FDA and our elected officials to protect women with much more thorough
and long term study regarding silicone implants. We have the right, and
need, to be as fully informed as possible about medical devices and
procedures. We can then make clearer choices for our health, rather than
succumb to the aesthetic pressure of our culture, at such great risk.
 
Copyright © 2004 - InTheKnow.org
                                   
                                   
                                   
                           

http://www.intheknow.org/stories9-5.shtml

Dear Members,

If you have not reported the adverse side effects you have experienced
due to your breast implants to MedWatch, it is very important that you
do so.

MedWatch is the FDA's 'watchdog' agency which accumulates adverse
reports on medical devices, such as breast implants.  This is the source
of statistics quoted by the FDA, therefore it is imperative that all
adverse reports be sent to this agency.  In order for the FDA to
accurately report the number of adverse side effects and malfunctions,
they have to have accurate reports sent to them via the patient who
experiences the adverse effects.

Reports to MedWatch can be sent via the internet or by U.S. Postal Mail.
This is the link to MedWatch where you can find more information on how
to file a report.

This is very important to do.  All women who have experienced adverse
side effects from their breast implants should file a report with
MedWatch as soon as is possible.

This message will be periodically sent to our group to inform and remind
new members to file their reports.

Thank you,

Lany


MedWatch Online Reporting Form 3500

Address:https://www.accessdata.fda.gov/scripts/medwatch/

https://www.accessdata.fda.gov/scripts/medwatch/

**Note from Lany:  I truly do feel it is ashame that Dow Chemical's
liability in this case will never be proven in court, and therefore,
punished, however, I also feel it is time to release the monies owed to
the women who are ill and suffering.  Twelve years of litigation is
extremely excessive.  I know that our women need help now, and cannot
afford to wait for more legal argument.  I'm glad to see it finally come
to an end.

I also hope that after payments are released that the women involved
will stay active in our groups and continue to help other women.  After
all, with the huge amount of women who have been augmented in the last
decade, and those who will be augmented in the future, there will be
hundreds of thousands of women who will need our help when they, too,
begin having problems.  I pray that Dow's measly payments won't cause
those paid to drift away from our purpose.

Blessings,

Lany


Nevadans Drop Last Obstacle To Dow Corning Settlement Plan;

CORRECTING AND REPLACING Nevadans Drop Last Obstacle To Dow Corning
Settlement Plan; Breast Implant Claimants Should Start Receiving Checks
This Year

ATLANTA--(BUSINESS WIRE)--03/19/2004--Headline of release should read:
Nevadans Drop Last Obstacle To Dow Corning Settlement Plan; Breast
Implant Claimants Should Start Receiving Checks This Year (sted Nevadans
Drop Last Obstacle To DOW Settlement Plan; Breast Implant Claimants
Should Start Receiving Checks This Year). 

   The corrected release reads: 

   NEVADANS DROP LAST OBSTACLE TO DOW CORNING SETTLEMENT PLAN;
BREAST IMPLANT CLAIMANTS SHOULD START RECEIVING CHECKS THIS YEAR 

   The last legal hurdle to finalizing the massive Dow Corning
bankruptcy was overcome today when a Nevada attorney agreed to dismiss
his claims against parent company Dow Chemical.

Administrators of the $2.35 billion fund may complete processing claims
so that tens of thousands of women injured by breast implants and other
implantable devices may be paid.

   "I continue to believe Dow Chemical was responsible for the pain
and suffering of untold numbers of women," said Nevada counsel Geoff
White of the law firm White, Meany and Weatherall. "My brother John and
I fought long and hard for the Nevada women. It simply became clear that
the process would take too long for very sick women in Nevada and
elsewhere to recover for their injuries."

White represents 48 Nevada women who have been the last plaintiffs to
sign off on the Dow Corning bankruptcy. His brother, John White of White
Law, Chartered, is the Nevadans' bankruptcy counsel.

   "We commend the Nevada women and their lawyers for dismissing
their appeal for the greater good. Now all claimants can pursue their
rights under the Plan of Reorganization," said Ralph Knowles of
Doffermyre, Shields, Canfield, Knowles & Devine, a member of the Tort
Claimants Committee. "The Tort Claimants' Committee represents the
interests of all women - whether from New York or Texas or Nevada or
anywhere else. We look forward to moving ahead with all claimants and
their counsel to insist that their rights under the Plan are protected
and prosecuted."

   Like all other claimants, the Nevada women will be able to either
elect a settlement option or litigate according to the Plan's terms. But
they have foregone their ability to sue Dow Chemical. Dow Corning
insisted that Dow Chemical be released from litigation as a condition of
finalizing the reorganization plan.

   The Nevada attorneys and others have claimed that Dow Corning
parent company Dow Chemical was responsible for helping test the safety
of silicone and for misleading the public about its safety. In 1995, a
Nevada jury imposed liability on Dow Chemical on behalf of Charlotte
Mahlum. This judgment was upheld on appeal before the Nevada Supreme
Court.
The Nevada claim was the last claim standing against the chemical giant,
whose market capitalization is almost $38 billion.

   The Dow Corning Plan of Reorganization was approved in 1999, but
has been held up by a variety of claims, including certain foreign
claimants and a U.S. government appeal aimed at reclaiming medical
expenses related to breast implant injuries.

   Earlier this year, the U.S. Food and Drug Administration refused
to lift restrictions on the sale of silicone gel breast implants, citing
concerns about rupture, silicone leakage, painful local complications
and possible long-term illness. 

Legal Timeline

2002    A federal judge in Detroit authorizes a $9.8 million
settlement between Dow Corning and the federal government for  medical
expenses stemming from breast implant-related  injuries, marking the
removal of the second-to-last barrier to        
compensating women for damages caused by Dow Corning's breast implants.
1999    Plaintiffs agree to Dow Corning's offer to settle tens
of  thousands of claims of injury from silicone breast implants. The
agreement will allow Dow Corning to emerge from bankruptcy proceedings.

1998    Dow Corning files for Plan of Reorganization, which
includes  the $2.3 billion (net present value) previously agreed-to
settlement and offers claimants several payout options.

1997    A Louisiana jury finds Dow Chemical guilty of fraud, 
negligence, conspiracy and three other counts in the first phase of a
state-wide class action.

1995    Dow Corning files for Chapter 11 bankruptcy. In November,
a new global settlement is devised minus Dow Corning. Baxter,  3M, and
Bristol-Myers Squibb are the participants.

        In October, Nevada attorney Geoff White's client
Charlotte  Malhum wins her suit against Dow Chemical for breast
implant  injuries. Malhum maintained that Dow Chemical failed to 
disclose important facts about silicone implants, and that Dow

        Chemical was liable because the company tested the
materials  used in the breast implants. The Nevada Supreme Court
upheld the verdict on appeal.
1994    A federal judge approves a $4.25 billion "global"
settlement offer by the large implant manufacturers (Dow Corning,
Baxter,  3M, and Bristol-Myers Squibb) to settle all lawsuits.

1992    The U.S. FDA restricts the sale of silicone gel breast
implants because of an absence of safety data. The greatest concern was
the growing evidence that implants did not last a  lifetime, as had
been claimed, and would eventually rupture, leaking silicone that then
was show to travel throughout the body.

1976    Congress passes the Medical Device Amendments to the
Food,  Drug and Cosmetic Act, giving the U.S. FDA responsibility for
regulating all medical devices for the first time. Since breast implants
had previously been sold in the U.S., they are "grandfathered in" and
allowed to stay on the market, although the manufacturers had submitted
no data that they were safe.

CONTACT:Doffermyre, Shield, Canfield, Knowles & Devine, LLC Jamie
Warner, 202-466-7247

SOURCE: Doffermyre, Shield, Canfield, Knowles & Devine, LLC
03/19/2004 13:02 EASTERN
   

Breast-Implant Sufferers to Finally See Cash from Dow Corning .. 2
articles

http://www.miami.com/mld/miamiherald/business/national/8249089.htm

Posted on Mon, Mar. 22, 2004

Breast-Implant Sufferers to Finally See Cash from Dow Corning

By Patricia Anstett, Detroit Free Press Knight Ridder/Tribune Business
News
Mar. 20 - The final legal roadblock in the nation's largest product
liability case was removed Friday, clearing the way for checks to be
mailed as early as June 1 to 360,000 people with health problems linked
to Dow Corning silicone implants. Claimants who have had trouble with
breast and other implants will receive $10,000 to $330,000, depending on
their health.
The controversial case involved 7,000 lawsuits dating to 1990. It
bankrupted Midland-based Dow Corning Corp., once the nation's largest
implant maker. About $2.35 billion has been set aside by the company for
disbursement by a federal-court-appointed agency. Now, Dow Corning can
proceed with its reorganization plan.
"This is finally going to happen," said Sybil Niden Goldrich, a Los
Angeles breast cancer survivor who represented other implant recipients
in what several attorneys in the litigation say is the biggest
consolidated product liability case in U.S. history.
Cases against tobacco and asbestos firms involved larger payouts, but
came through numerous lawsuits.
The long-awaited development -- 12 years after the federal Food and Drug
Administration restricted use of silicone implants because of health
concerns -- follows a decision Thursday by Reno, Nev., attorney Geoff
White to withdraw his appeal on behalf of 48 Nevada women. It was the
final appeal to be resolved of many that have held up the case.
On Friday, Ralph Knowles, the lawyer representing implant recipients in
the case, along with Dow Corning and other parties in the case, filed a
motion with the U.S. 6th Circuit Court of Appeals in Cincinnati to
formally dismiss the Nevada appeal.
The action paves the way for Detroit's U.S. District Judge Denise Page
Hood to approve the bankruptcy plan of Dow Corning.
"The plan will be approved," Knowles said. "It's inconceivable to me
that it wouldn't be."
Hood has not set a date to make a decision, court officials said Friday.
Once Hood's court gives the go-ahead to make payments, the settlement
trust facility -- known as the Settlement Facility Dow Corning Trust
(SFDCT) -- will send a booklet to people registered with the court
explaining the settlement. The booklets eventually will be on the
facility's Web site: www.dcsettlement.com.
Because of the size of the case, checks already are being printed,
Goldrich said.
Dow Corning, a joint venture of Midland-based Dow Chemical Co. and
Corning Inc. of Corning, N.Y., was forced into bankruptcy in 1995 as it
faced thousands of lawsuits charging that silicone implants made by the
company caused a variety of diseases, including lupus and fibromyalgia,
a stiff-joint condition. Some of the worst problems occurred in women
whose implants ruptured. As part of the company's reorganization plan,
it set aside a fund to pay implant claimants.
The settlement stipulated that Dow Chemical could not be sued. But White
appealed, and the Nevada Supreme Court upheld the appeal, setting in
motion five years of appeals. Other appeals by the federal government
and foreign litigants also held up the case. The delays, though
regrettable, helped make Dow Chemical more willing to contribute to the
settlement with loans and other money, White said.
"We got into the deeper pockets" of Dow Chemical, he said.
The largest payments will be $330,000 and will go to U.S. breast implant
patients with the most serious health problems.
The payout includes $5,000 for surgery to remove the implants; $25,000
for ruptured implants, and $300,000 for lifetime care for serious
medical problems such as lupus, an autoimmune disease that can cause
heart attacks and other serious complications.
Most payments are likely to be in the $10,000 to $30,000 range,
attorneys for the case said.
Silicone implant recipients who don't want to be part of the broad
settlement can file to have their cases considered by Hood this year.
It's not known how long those people will be given to file additional
claims. After those payouts are estimated and if court officials believe
money will be left over, plaintiffs in the bigger settlement group will
get additional payouts of 20 percent of their original payments, Knowles
said.
Of more than 359,000 people to register claims, 136,000 are U.S.
residents with a Dow Corning implant for either post-cancer breast
reconstruction or for cosmetic reasons to increase breast size. Another
41,000 are foreign women with Dow Corning implants.
The rest are patients who have Dow Corning silicone materials for knee,
hip, jaw, nose, penile, testicular, finger and toe implants.
Earlier this year, the FDA turned down a request by a manufacturer to
return silicone implants to the market. But they continue to be
available to women who agree to be followed carefully in research
studies.
HOW MUCH WILL BE PAID
These payouts will be made in the Dow Corning case, once approved by
Detroit U.S. District Judge Denise Page Hood:
--Three tiers of payments, at $10,000, $20,000 and $30,000, for most of
the 360,000 claimants in the case.
--$330,000 for a small number of U.S. breast implant patients with the
most serious health problems. The money includes $25,000 for ruptured
implants, $5,000 for implant removal and $300,000 for lifetime care.
Future settlement updates will be available by calling 888-875-5949 or
by visiting www.dcsettlement.com. Neither was updated Friday. Also,
visit the Dow Corning Web site at www.dowcorning.com.
TIMELINE OF SILICONE IMPLANTS
1960s: Silicone becomes the main material used in breast implants for
plastic surgery or reconstruction after breast cancer surgery.
1990: The U.S. news media publish reports about serious health problems
linked to the implants. In the next two years, thousands of people with
implants file suit against the Midland-based Dow Corning Corp.
January 1992: The federal Food and Drug Administration bans all but
limited use, under careful studies, of silicone breast implants.
May 1995: Dow Corning Corp., once the nation's leading manufacturer of
silicone breast implants, files for bankruptcy.
June 1999: Thousands of lawsuits are consolidated against Dow Corning as
part of the bankruptcy case. Also, a report from the Institute of
Medicine, reviewing about 3,000 implant studies, concludes there is
insufficient evidence to prove that silicone breast implants cause
serious diseases. But it also finds that one in four women needs
repeated surgeries to fix or remove implants and that implants can block
mammogram pictures, a serious issue for breast cancer patients.
January 2002: The U.S. 6th Circuit Court of Appeals rules that Dow
Chemical Co., a shareholder of Dow Corning, could be released from
liability in the case.
January 2004: The U.S. Food and Drug Administration tells
California-based Inamed Corp., a leading breast implant manufacturer,
that it will not allow commercial use of silicone implants.
-----
To see more of the Detroit Free Press, or to subscribe to the newspaper,
go to http://www.freep.com
~~~~~~~~~~~~~~~~~~~~~~
http://www.usatoday.com/money/industries/health/2004-03-19-breast-implants_x.htm
Posted 3/19/2004 2:24 PM
~~~~~~~~~~~~~~~
• Women drop appeal of breast implant settlement - 2:24 PM
Women drop appeal of breast implant settlement
DETROIT (AP) — A major obstacle to Dow Corning's plan to settle with
women who say silicone breast implants made them sick was removed Friday
when the last group of women dropped its appeal. A lawyer involved in
the settlement said the move paves the way for U.S. District Judge
Denise Page Hood to set a date for payments to start.
Dow Corning, a joint venture of Dow Chemical and Corning, was forced
into bankruptcy in 1995 after thousands of women filed claims that
implants made by the company damaged their health.
As part of the company's reorganization plan, it set aside a fund
currently worth $2.35 billion to pay implant claimants.
Most plaintiffs agreed to the settlement, which stipulated that Dow
Chemical cannot be sued, but a group of 48 Nevada women appealed. The
Nevada Supreme Court had upheld a civil decision against Dow Chemical
over silicone implants.
"I continue to believe Dow Chemical was responsible for the pain and
suffering of untold numbers of women," Geoff White, a lawyer for the
Nevada women, said in a statement. "It simply became clear that the
process would take too long for very sick women in Nevada and elsewhere
to recover for their injuries."
Dow Corning spokeswoman Mary Lou Benecke said the company was pleased
with the decision to drop the appeal.
"This dismissal ... is something that will move the case forward,"
Benecke said.
Benecke said some issues remain with creditors before the plan can be
implemented.
But Atlanta attorney Ralph Knowles, a member of the claimants committee
that represented people who sued the manufacturer, said those issues are
mostly technical matters.
"My guess is that those issues will get worked out quickly or the judge
will do something that will obviate the problem," he said.
The settlement effects hundreds of thousands of claimants with all types
of silicone implants — not just breast implants, Knowles said.
Under the plan, individuals can receive from several thousand dollars up
to $200,000 if they agree to the settlement. About $400 million from the
fund is set aside for litigation, Knowles said.
"There are obviously cases where $200,000 is woefully inadequate," he
said.
Knowles said many claimants had been frustrated with the delays caused
by the Nevada appeal.
"I think Geoff White and his clients certainly had the right to raise
the issue," Knowles said. "I'm appreciative of what they've done. ... We
literally have claimants dying and desperately in need of money."

Nevada Women drop appeal of Dow Corning breast implant settlement plan,
3/19/04

I think it is very important that when these checks finally are sent
out, we generate stories about how much (or little) the women are
getting for their illnesses. 

Please keep us informed so that we can make sure there is accurate press
coverage -- and more personal stories in op-eds so that other women will
know what has happened.
 
Best wishes,
Diana
 
http://www.myrtlebeachonline.com/mld/myrtlebeachonline/business/8228394.htm
 
Posted on Fri, Mar. 19, 2004
Women drop appeal of Dow Corning breast implant settlement plan
SARAH KARUSH
Associated Press
DETROIT - Some 170,000 women who claim silicone breast implants made
them sick could begin receiving settlement checks within months after a
lawyer dropped an appeal that had held up payments for years.
A lawyer involved in the settlement with the Dow Corning Corp. said
Friday that the first checks should go out by the end of the year.
Dow Corning, a joint venture of Midland-based Dow Chemical and Corning,
N.Y.-based Corning Inc., was forced into bankruptcy in 1995 after
thousands of women filed claims that implants made by the company
damaged their health.
As part of the company's reorganization plan, it set aside a fund
currently worth $2.35 billion to pay implant claimants.
Approximately 170,000 women who received breast implants have filed
claims, said Dow Corning spokeswoman Amy Rosborough. There are many
other claimants who had other kinds of silicone implants, including
joint and facial implants, but Rosborough could not say how many.
Most plaintiffs had agreed to a settlement plan, which stipulated that
Dow Chemical cannot be sued but left open the possibility of litigation
with Dow Corning. But a lawyer representing 48 Nevada women appealed,
citing a Nevada court ruling upholding damages against Dow Chemical in a
breast implant case.
"I continue to believe Dow Chemical was responsible for the pain and
suffering of untold numbers of women," Geoff White, a lawyer for the
Nevada women, said in a statement. "It simply became clear that the
process would take too long for very sick women in Nevada and elsewhere
to recover for their injuries."
Dow Corning spokeswoman Mary Lou Benecke said the company was pleased
with the decision Thursday to drop the appeal.
"This dismissal ... is something that will move the case forward,"
Benecke said.
Benecke said there still were some issues pending with creditors before
the plan can be implemented.
But Atlanta attorney Ralph Knowles, a member of the claimants committee
that represents everybody with implant claims against Dow Corning, said
those issues mostly are technical matters.
"My hope is that checks will start going out in three to four months,"
he said, adding that he was confident payments would start by the fall.
Under the plan, individuals can receive anywhere from $2,000 to $330,000
if they agree to the settlement, though Knowles said $200,000 is a more
reasonable expectation for people with serious diseases.
About $400 million from the fund is set aside for litigation, he said.
Claimants can sue the Dow Corning litigation facility, an independent
entity set up under the reorganization plan.
"There are obviously cases where $200,000 is woefully inadequate,"
Knowles said.
Many claimants had been frustrated with the delays caused by the Nevada
appeal, he said.
"I think Geoff White and his clients certainly had the right to raise
the issue," Knowles said. "I'm appreciative of what they've done. ... We
literally have claimants dying and desperately in need of money."
After White's clients agreed in principle to give up their claims
against Dow Chemical, the payments were further held up by White's
demand that his clients not be saddled with his costs - including fees
owed to his brother John, who served as their bankruptcy counsel.
Eventually, dozens of lawyers representing claimants in the United
States and Canada chipped in to raise the $400,000 White says he and his
brother are owed.
White defended his demand, saying the costs of other attorneys are
covered under the settlement. He said it would be wrong to let the bill
cut into the money his clients will receive after they gave up their
right to pursue bigger awards from Dow Chemical.
Sybil Niden Goldrich, a member of the claimants committee and a claimant
herself, said Thursday's developments were "a long time in coming."
Goldrich, who had four sets of breast implants after a bilateral
mastectomy, said people have had a range of autoimmune responses to
silicone implants.
"I thought I was sick from advanced cancer, but it turned out I was sick
from the implants," she said.
Goldrich said she recovered after the implants were removed 20 years
ago.
Dow Chemical's shares fell 13 cents to $39.15 Friday on the New York
Stock Exchange; Corning's shares fell 31 cents to $10.57.
ON THE NET
Dow Corning Corp.: http://www.dowcorning.com
Settlement Facility for Dow Corning Trust: http://www.dcsettlement.com
 

Plaintiffs May Recover for Implants' Disclosed Risks

Michael A. Riccardi <mailto:letters_to_the_editor@...>

The Legal Intelligencer <http://www.law.com/pa>
03-19-2004

Plaintiffs who sue breast implant doctors for lack of informed consent
may
recover not only for damages from undisclosed risks, but also for
damages
flowing from all risks, the panel handling silicone implant litigation
has
said in a case of first impression.

Allegheny County Common Pleas Judge R. Stanton Wettick Jr. wrote the
decision in In re: Silicone Breast Implant Litigation as chairman of
Pennsylvania's coordinating court for silicone implant litigation.

The court agreed with the plaintiffs, who argued that once one has
suffered
an injury from an undisclosed risk of a medical procedure, he or she is
entitled to recover for all of the injuries sustained in the procedure.
The defendants argued for a more restrictive view of recovery.

General principles of law supported the plaintiffs' argument for
wide-open
recovery, Wettick reasoned. The theory of informed consent states that
without proper consent from the patient, a surgical operation is a
battery.

Such a theory presumes that if informed consent is flawed because of an
unwarned-of material risk, the surgery should not have taken place.
Therefore, the plaintiffs argued, any harm -- warned of or not -- is
damage stemming from the battery.

What is crucial is the jury's conclusion that the undisclosed risk would
be
considered significant in deciding whether to have the operation; that
is, whether the non-disclosure related to a "material fact."
"If a jury finds that the injury is a material undisclosed risk of the
procedure, the patient is deemed to have not consented to the procedure
because of the undisclosed potential risk," Wettick wrote.

"The patient is treated in the same fashion as if there were a jury
finding that a reasonably prudent patient would not have proceeded with
the operation had the patient known that the risks of the operation
included the undisclosed
injuries the patient sustained."

There is nothing inconsistent, Wettick said, with the court's ruling on
disclosed risks and a September decision by the same panel barring a
lack of informed consent claim unless there was an injury connected to
the undisclosed risk.

In the September opinion, the plaintiff was not entitled to damages
because she had agreed to surgery that could potentially produce the
injuries that she sustained, Wettick reasoned. In this case, on the
other hand, the plaintiff did suffer injury from an undisclosed risk,
and she was entitled to be placed in the position she would be in had
she rejected the operation on the basis of the material fact that was
not disclosed.

The court therefore denied the defendant's motion in limine seeking to
limit evidence related to plaintiffs' damages to damages related to only
undisclosed risks.

The court also denied the defendant's motion in limine seeking to
exclude a
patient whose implants have not been removed from seeking damages
related to the removal of the implants. The court agreed with the
plaintiffs that recovery for removal of the implants in the future is
permitted in some circumstances.

1992/Blais/ BACTERIA IN BREAST IMPLANTS - From evidentiary files of
breast implant litigation

Thanks to Pam Dowd for sending the following from the evidentiary files
of breast implant litigation. . .Myrl

DCC017001498

November 5, 1992   Toronto Sun

BACTERIA IN BREAST IMPLANTS?
MONTREAL (CP) - Ottawa chemist Pierre Blais and colleagues at Laval
University in Quebec City say they have found large colonies of germs in
surgically removed breast implants.

"We found huge amounts of infectious materials in both saline-filled and
silicone-gel implants," Blais said.

The implants were removed mostly from Canadian and American women who
were experiencing infection, respiratory and immune-system problems and
swelling and fever, Blais said.

"A couple of implants were so contaminated with fungi and other germs
that they had turned coal black."

Blais and his colleagues are using high-powered microscopes to examine
the germs.

But "in some cases, we could easily see signs of the infected materials
without a microscope," Blais said.

Some of the saline implants "have poorly designed valves that
unfortunately can allow protein and plasma from the woman to seep into
the liquid."
==================================

November 5, 1992

Montreal Gazette

LAVAL TEAM FINDS GERMS FLOURISHING IN BREAST IMPLANTS

Devices studied after removal
Ottawa chemist Pierre Skis and colleagues at University Laval in Quebec
City have found large colonies of germs in surgically removed breast
implants.

"We're finding huge amounts of infectious materials in both
saline-filled and silicone-gel filled breast implants that have been
removed mostly from Canadian and American women who are experiencing
infections, respiratory and immune-system problems, swelling and fever,"
Blais said in an interview this week.

"A couple of implants were so contaminated with fungi and other germs
that they had turned coal black," he said.

Blais and his colleagues are using high-powered microscopes to examine
the germs.

But "in some cases, we could easily see signs of the infected materials
without a microscope," Blais said.

"We're talking about grams of infected materials, not tiny amounts. It
includes bacteria exotic fungi some of which grow like miniature
mushrooms."

All breast implants have been known to have a small chance of causing
infection. But this is the first systematic investigation of infectious
materials trapped inside implants.

Some of the saline implants studied "have poorly designed valves that
unfortunately can allow protein and plasma from the woman to seep into
the liquid," Blais said.
"This may allow the germs to proliferate. And when some of these
colonies get big enough, the germs could release toxins that could
affect body tissue and nerves."

"The greatest danger to women with contaminated implants is that the
infectious material could spread through the body if the implants leak
or burst," he said.

"Once infection is in the body, the immune system would be forced to
react and it could trigger an inflammatory process."

So far the chemists have studied 20 sets of saline-filled implants from
various manufacturers. All the implants had some germs.

"The variety and high degree of contamination suggest that manufacturing
problems may be at fault, particularly inadequate sterilization," Blais
said.

But he said he had no proof that this was the case.

"Nor is there any way of knowing yet how many of the several million
sets of implants inserted in women in North America, mostly in the last
seven years, have been contaminated by genus," he said. "We've only
recently started looking at infection in implants and so we don't know
how widespread this problem is."

Blais cautioned that women with implants shouldn't jump to conclusions
on the basis of early study results because little is known yet about
breast implant contamination and the processes that might cause harm.

Since 1983, doctors, patients and lawyers representing women have been
sending removed breast implants to Blais and the Laval team, which is
led by chemist Robert Guidoin, an implant expert. Blais and Guidoin have
data on 1,400 sets of implants showing how they change or break down in
the body.

Blais is to present evidence from the study of contaminated implants at
a breast implant conference in Cleveland, Ohio, this weekend.

A moratorium on silicone gel-filled breast implants began in the U.& and
Canada last January after the U.S. Food and Drug Administration reviewed
safety data on several products and found the data inadequate. The
implants are now available to women in the U.S. who enroll in limited
studies.

But saline-filled implants remain widely available in the U.S. and
Canada.
Norman Anderson, an implant expert at Johns Hopkins University in
Baltimore, MD, told The Gazette yesterday that he has reviewed the
findings of implant contamination with Blais at length, and the
electron-microscope pictures "show absolutely unacceptable levels of
contamination."

Anderson, who has served on an FDA advisory committee on breast
implants, and Blais's work is raising "root questions about the lack of
[government] regulation of something as basic as proper sterilization of
implants."

He said the fact that regulatory agencies in Canada and the U.S.
neglected to establish registries of removed implants so that they could
be properly studied "now prevents us from telling the public what the
actual risk may be."

"Unfortunately, it's been common for plastic surgeons and manufacturers
to dispose of removed implants, probably because of their concerns about
possible lawsuits." The FDA now requires the registration of women
involved in breast-implant tests.

Anderson said Blais and his colleagues are the only ones who have been
systematically studying removed breast implants.

McGhan Medical Inc. of Santa Barbara, Calif, and Mentor Corp. also of
Santa Barbara, are the two remaining makers of saline and silicone-gel
implants in the U.S. Several manufacturers withdrew from the business
last year following negative FDA assessments of their products.

Dennis Condon, president of Mentor's surgical division, said he won't
comment on Blais and Guidoin's findings until he sees their report.

At McGhan, recent sales of silicone-gel implants were stopped after an
FDA inspection last April found lapses in sterilization as well as
inadequate quality control and record keeping said FDA spokesman Susan
Cruzan.

Before McGhan can sell its silicone-gel implants for test purposes, the
company must convince the FDA that it has made changes in the
manufacturing plant.

McGhan sent a statement to the Gazette yesterday saying that it will
continue to work with the FDA to improve its manufacturing process so
that production of implants may resume in the future.

1992 Breast Milk Testing - From evidentiary files of breast implant
litigation
Thanks to Pam Dowd for sending the following from the evidentiary files
of breast implant litigation. . .Myrl

DCC017001517

WEST COAST ANALYTICAL SERVICES

November 2O, 1992

BRODY, M.D. INC. GARRY S
Brookshire Medical Building #504
11411 Brookshire Avenue
Downey, California 90241
Attn:
Dr. Garry Brody
JOB NO. 22488

LABORATORY REPORT
Samples Received:       One (1) Breast Milk Sample Date Received:
9-30-92

Purchase Order No:   COD

The sample was analyzed as follows:
Samples Analyzed       Analysis                
      Results
One (1) Breast Milk     Silicone by GC/FID     Table 1

The sample was analyzed using modification of the procedure developed by
Dow Chemical for silicon. (po1ydimethy1silaxane) in water. The sample is
reacted with hydrochloric acid to hydrolyze the silicone to
dimethyldisilanol, than with hexamethyldisiloxane (HMDS) to generate
dimethoxydimethlsilane (D). This compound is then determined by gas
chromatography (GC).

The sample results are shown in Table 1. The detection limit is high
because of an interference in the method blank which was shown to be due
to D in the reagents.
This was shown using both QC and gas chromatography-mass spectrometry
(GCMS). Attempts to eliminate this interference by distilling the HMDS
failed.

No other interferences from the matrix were observed.

Bettina Oelke
Senior Chemist
Michael Shelton
Technical Director

This report to be reproduced in its entirety.
=============================================
GARRY S. BRODY, M.D., INC.     Job # 22488 Dr. Garry Brady November
20, 1992

LABORATORY REPORT
The chemical used in this procedure for calibration is
dichlorodimethylsilane (DCDS). The silicone gel used in implants could
not be dissolved in any solvent, so calibration solutions could not be
made from the gel. An attempt to disperse the gel in both homogenized
milk and whole cream using ultrasonication also failed. A sample of the
gel, unweighed, was taken successfully through the analytical procedure
showing that the test method is valid.

In conclusion, the method appears to work, but it appears that it is
impossible to disperse or dissolve the silicone gel in body fluids in
high enough concentrations to be measured. Dow developed the original
test for low molecular weight silicones, used as anti-foams-and
surfactants in water treatment, forms that are-water soluble. Perhaps
the test could be applied to tissues, however the presence of silicone
in tissues may be obvious from the situation. Since silicone gel is not
soluble in body fluids above 5ppm it may be unlikely to metabolize fast
enough to show an elemental silicon. The rate of elimination is probably
faster than the rate of metabolization.

While these results are negative, do you have any suggestions for
further research or where and how these results could be published?
===============================
WEST COAST ANALYTICAL SYSTEMS
GARRY S. BRODY, M.D. * INC
Dr. Carry Brady
LABORATORY REPORT
Job #22488
November 20, 1992
Table 1
Silicone by GC/FID
Sample ID       Parts per million (mg/l) Breast Milk, Chase D. L.
      N. D.
Detection Limit
•High detection limit due to an interference in blank.
Date extracted: 10/2/92
Date Analyzed: 10/6/92

Sarcoidosis
April 3, 2004
 
About Sarcoidosis

What Causes Sarcoidosis?

What Are The Symptoms Of Sarcoidosis?

How Is Sarcoidosis Diagnosed?

How Serious Is Sarcoidosis?

Who Gets Sarcoidosis?

What Body Sites Does Sarcoidosis Attack?

What Is The Common Course Of Sarcoidosis?

What Is The Treatment For Sarcoidosis?

What Can The Sarcoidosis Patient Do?

In Summary


ABOUT SARCOIDOSIS

Sarcoidosis is a disease due to inflammation.
The disease can attack any organ of the body in any location. The
disease is characterized by the presence of granulomas, small areas of
inflamed cells.
They can be either inside the body or on the body's exterior, appearing
as sores on the face or shins. But sarcoidosis is most frequently found
in the lungs.

Pulmonary sarcoidosis can cause loss of lung volume (the amount of air
the lungs can hold) and abnormal lung stiffness.
Granulomas can appear on the walls of the alveoli (small air sacs in the
lungs) or on the walls of the bronchioles (breathing tubes in the
lungs). They also appear in the lymph nodes in the chest, causing them
to enlarge.

WHAT CAUSES SARCOIDOSIS?

No one yet knows what causes sarcoidosis.

It is thought by most scientists to be a disorder of the immune system,
where the body's natural defense system malfunctions.

Some physicians believe that sarcoidosis may result from a respiratory
infection caused by a virus. Others suspect that exposure to toxins or
allergens in the environment is to blame. Researchers are looking for
answers to this and many other questions about sarcoidosis.

WHAT ARE THE SYMPTOMS OF SARCOIDOSIS?

In pulmonary sarcoidosis, patients may have a dry cough (without
sputum), shortness of breath, or mild chest pain.
In those cases where symptoms do appear outside the lung, they can
include a scaly rash, red bumps on the legs, fever, soreness of the
eyes, and pain and swelling of the ankles.
There can also be more general symptoms like fatigue, weakness, fever,
and weight loss. These symptoms are common in many other lung diseases,
so diagnosis may be difficult.

HOW IS SARCOIDOSIS DIAGNOSED?

Any of the symptoms listed in the previous section may lead a physician
to consider sarcoidosis. Sarcoidosis is initially diagnosed based on a
physical examination, laboratory tests, pulmonary function studies, and
a chest X-ray. When enlargement of lymph glands in the center of the
lungs is seen on X-ray, sarcoidosis may be suspected.
To confirm the diagnosis, a biopsy is usually performed on any of the
affected organs or from material in a granuloma on the skin.

HOW SERIOUS IS SARCOIDOSIS?

In over half the cases, sarcoidosis appears briefly and heals naturally.
Sometimes the patient doesn't even know or do anything about it. From 20
to 30 percent of pulmonary sarcoidosis patients are left with permanent
lung damage. And for a small percentage of patients, their sarcoidosis
can become chronic, lasting for many years.
No one can predict how sarcoidosis will affect an individual patient.
but several things are certain that may reassure the patient.
Sarcoidosis is not contagious. And there is no evidence that it can be
inherited, and passed from parents to children.

WHO GETS SARCOIDOSIS?

Sarcoidosis is found throughout the world among almost all races and
ages and in both sexes. However, it is most common among African
Americans and northern European whites.

Sarcoidosis is mainly a disease of young adults -- patients between the
ages of 20 and 40 -- although a few persons past 60 have been known to
contract it.

In the United States, a higher percentage of African Americans than
whites has sarcoidosis, and the disease is usually more serious in them.
The prevalence of sarcoidosis is eight times greater in African
Americans than in whites in the U.S.

WHAT BODY SITES DOES SARCOIDOSIS ATTACK?

Ninety percent of the cases of sarcoidosis are found in the lungs.

Other commonly affected Other sites are:

Skin

Liver

Lymph glands

Spleen

Eyes

Nervous system, including the brain

Musculoskeletal system (the muscles and bones in the body)

Heart

Kidneys

WHAT IS THE COMMON COURSE OF SARCOIDOSIS?

In most cases of sarcoidosis that have no symptoms, the disease "burns
itself out," disappearing with little or no notice to the patient or
physician.

If pulmonary sarcoidosis is serious, it can develop into pulmonary
fibrosis (the abnormal formation of fiber-like scar tissue in the lung).
This actually distorts the structure of the lungs and can interfere with
breathing, especially the ability to exchange oxygen in the lungs.

WHAT IS THE TREATMENT FOR SARCOIDOSIS?

In a majority of patients, the disease spontaneously disappears, and no
treatment is necessary.

When therapy is recommended, the main goal is to keep the lungs and
other affected body organs working, and to relieve symptoms. Drugs
called corticosteroids are the most common treatment used in fighting
sarcoidosis.

Some physicians prescribe steroids when there are no symptoms but just
abnormalities seen on the chest x-ray and in lung function measurements.

Other physicians wait for symptoms to appear before prescribing
corticosteroids.
Frequent check-ups are important so the doctor can monitor the illness
and, if necessary, adjust the treatment.

WHAT CAN THE SARCOIDOSIS PATIENT DO?

The sarcoidosis patient should follow his or her doctor's directions.
This frequently can be just continuation of a normal lifestyle. When
drugs are prescribed, they should be taken faithfully, just as the
physician directs.

It is particularly important that sarcoidosis patients do not smoke.

IN SUMMARY

Most people with sarcoidosis can lead a normal life. The sarcoidosis
patient should follow his or her doctor's directions. When drugs are
prescribed, they should be taken faithfully just as the physician
directs.

It is particularly important that sarcoidosis patients do not smoke, and
avoid exposure to dust adn chemicals that can harm the lungs.

Even after sarcoidosis heals, and symptoms go away, patients should have
a check-up and an eye exam every year.

http://www.lungusa.org/diseases/lungsarcoido.html

From: Kathynye

Date: Fri, Apr 2, 2004

Subject: POST: FLASH....Timeline Set for Breast Implant Deal

Timeline Set for Breast Implant Deal

By DAVID RUNK
.c The Associated Press

DETROIT (AP) - Thousands of women who said Dow Corning silicone breast
implants made them sick could soon receive checks from a $2.35 billion
settlement fund after a judge set a date Friday for the company to
emerge from bankruptcy.

The federal judge's order came about two weeks after a Nevada lawyer
dropped a challenge that had held up payments for years.

The payments could begin on June 15.

``This has been such a long time in coming,´´ said Sybil Niden
Goldrich, a claimant who also sits on a committee that represents other
people with health complaints. ``Now there´s nothing standing in the
way for women to be getting money that they need very badly for their
medical care to proceed.´´

Dow Corning was forced into bankruptcy in 1995 after 170,000 women sued
the company, saying its implants damaged their health. In a settlement
approved by a federal judge, Dow Corning agreed to pay women $2,000 to
$330,000 each.

But until two weeks ago, a group of 48 Nevada women had objected to the
terms, holding out for an average of $200,000 per person.

Dow Corning spokeswoman Mary Lou Benecke said the company is pleased
that it is scheduled to emerge from bankruptcy on June 1.

On the Net:

Dow Corning Corp.:

http://www.dowcorning.com

Settlement Facility for Dow Corning Trust:
http://www.dcsettlement.com

04/02/04 17:06 EST
   
--------------------------------------------------------------------------------\
----------------------
Subj: Press Statement by Sybil Niden Goldrich, Command Trust...

DPress Statement by Sybil Niden Goldrich, Command Trust Network

Dow Corning Settlement Final
Implant Women May Soon Start Receiving Checks

WASHINGTON, April 2 /PRNewswire/ -- Today U.S. District Court Judge
Denise Page Hood set June 1st as the effective settlement date in the
Dow Corning breast implant case, finally allowing injured people's
claims to be processed. The court-appointed claims administrator says
that thousands of letters will go out June 1st and that the first checks
should be mailed June 15th.

The case started in 1995 when the former breast implant manufacturer
filed for bankruptcy in the face of thousands of claims.  The details
of the company's bankruptcy were confirmed in 1998, but it took several
years for the appeals process to die down.

There is currently $2.35 billion set aside in a court fund.  Implant
survivors may receive from $2,000 to $250,000.  Details are available
to the public at

www.dcsettlement.com or by calling 1-864-874-6099.

Statement 

"I communicate with hundreds of women every week who feel they have
nowhere to turn.  Although a little bit of money will never make up
for their suffering, at least this chapter is closing."

"Some women will finally be able to pay for much needed medical care."

"We have waited many long years for justice to be done.  People have
sickened and died while waiting."

"I commend the U.S. FDA for not lifting restrictions on implants earlier
this year.  Now at least another generation of women will not suffer
as I did."

Goldrich is a cancer survivor injured by implants who serves as the
women's consumer representative on the Tort Claimants' Committee, the
body that negotiated on behalf of people injured by silicone
implants.  She received silicone gel breast implants after a bilateral
mastectomy.  The devices caused terrible problems.  Her doctors
advised her to have them replaced several times.  Years after they
were removed surgeons found silicone in her liver during a
hysterectomy.  A biopsy performed later found silicone in her
liver.  "I survived the cancer, but I don't know if I'll survive the
implants," Goldrich has said.

Her moving story in Ms. Magazine in 1988 first brought the matter to
public attention.  Her story on Connie Chung's
"Eye to Eye" and her activism led to the congressional hearings that
brought about restrictions on the sale of the devices.  Earlier this
year, the U.S. Food and Drug Administration chose not to lift those
restrictions.

SOURCE  Command Trust Network 
CO:  Command Trust Network; Dow Corning

ST:  District of Columbia

SU:  WOM LAW

Web site:  http://www.dcsettlement.com
http://www.prnewswire.com
--------------------------------------------------------------------------------\
-------------
04/02/2004 16:34 EST

   Toxic Alert

Date: 4/2/2004 2:36:33 PM Eastern Standard Time

From:
toxicnewsandviews@...

ORDER ESTABLISHING EFFECTIVE DATE FOR AMENDED JOINT PLAN OF
REORGANIZATION  The Court having received the March 24, 2004 order of
the United States Court of Appeals for the Sixth Circuit dismissing the
appeal of the Nevada Claimants, and it appearing that the dismissal of
this appeal eliminates the last remaining impediment to establishing the
Effective Date under the Amended Joint Plan of Reorganization of Dow
Corning Corporation, IT IS HEREBY ORDERED THAT:
1.                 
1. The Plan Proponents and the Claims Administrator are authorized and
directed to take all steps necessary to cause the Effective Date for the
Amended Joint Plan of Reorganization to occur on June 1, 2004.

2.                 
2. The rights and objections of the Debtor and the Commercial Committee
with respect to the issues relating to the Effective Date as it relates
to Class 4 are preserved, including whether or not there should be a
separate Effective Date as to Class 4 and such issues shall be heard on
April 29, 2004. 

Dated: April 02, 2004
                                      
s/ Denise Page Hood
Denise Page Hood
United States District Judge 

Dow Corning's Silicone Site


Silicones from Dow Corning
Address:http://www.dowcorning.com/

http://www.dowcorning.com/