United Silicone Survivors of the World - October 1996

[Guest guest]

USSW NEWS

United Silicone Survivors of the World

October 1996

Offical Journal - International Circulation

A Woman in My Position: the politics of breast implant

safety

By with Dianne Brown

" Dr. Blais said that once inside the body, the

polyurethane covring begins to disintegrate almost

immediately. It could become entwined with breast

tissues rendering its complete removal virtually

impossible and it could make the treatment of

infection prolonged and difficult. "

It's Not My Fault

On January 4, 1988, ABC's " 20/20 " aired a segment on

breast implants. I had never seen anything about them

on TV before and I decided to record the program so I

could pass it along to my lawyer. The reporters dealt

with women who suffered " capsular contracture " after

the insertion of their implants. Capsular contracture

is a condition that develops when the body naturally

forms a wall of scar tissue as a defense around the

implant. This buildup of scar tissue can contract and

distort the shape of the implants, resulting in the

breast feeling hard and becoming misshapen. This can

be an extremely painful condition. Although doctors

interviewed on the show claimed the incidence was very

low, the Head of the American Plastic Surgeons

Association admitted it might be as high as 40%.

The camera zeroed in on a newer type of implant that

its manufacturers claimed drastically reduced the

incidence of this problem. It was the Meme. The main

message from Barbara Walters and Dr.

was that, before having the Meme implant, women should

wait until more was known about its performace. I

expected this new implant to look like the one Dr.

Guichon had removed from me back in 1985. What I saw

bore no resemblance to it. When the program was over,

I rewound the tape to get a second look. I rewound the

tape time and time again and the more I saw it, the

more I knew that it was not what had been taken out of

me. Yet I knew that Dr. Guichon had used the Meme.

suggested that perhaps I had forgotten what it

had looked like. I assured him I would never forget. I

decided to find out what the difference was. Not sure

where to start, my first call was to the Cancer

Society in Vancouver. They suggested that I contact

the local office of the Health Protection Branch,

Health and Welfare Canada, because they kept records

of all medical devices on the market. Mr.

Hutcheon of th Health Protection Branch in Burnaby

Britisch Columbia, told me he would get back to me

within a few days. A week later, he had not been able

to turn up anything so he passed my inquiry along to

someone else who would contact me.

It is amazing how things have a way of turing out. Our

first day in court was to have been 4 january, 1988.

Just days before, both lawyers felt they needed more

time to prepare. Initially I was disappointed. I had

waited more than a year and wanted to get this over

and done with. However, if an adjournment was in my

best interest, I would agree.

Early one morning in mid-february, the telephone rang.

Dr. Pierre Blais, from the Bureau of Radiation and

Medical Devices, Health and Welfare Canada, introduced

himself. He was calling in reply to my inquiry about

Meme breast implants. A soft-spoken man with a

distinctive French accent, Dr. Blais asked me to tell

him a little about the problems I had ecountered. He

explained that the Meme was made of silicone and

polyurethane foam. Silicone is produced in several

solid forms as well as gels. The Meme was comprised of

silicone gel, encased in a silicone bag or " envelope " ,

as it is called in the medical literature. Glued to

the bag was a thin layer of polyurethane foam. Dr.

Blais said that once inside the body, the polyurethane

covring begins to disintegrate almost immediately. It

could become entwined with breast tissues rendering

its complete removal virtually impossible and it could

make the treatment of infection prolonged and

difficult. As well, its was uncertain what happened to

the foam through its process of disintegration and

what long-term effects its by-products could have.

Although he didn't know for certain. Dr. Blais

suspected that the foam being used on the Meme

implants was an industrial grade, commonly used in

carburetor filters, furniture and mattresses. If it

was industrial-grade, its quality standards and

sterility would be below those required for medical

devices implanted within the body. (I found out later

that silicone is comprised of the widely-distributed

nonmetallic element silicone which is used to make

glass, along with a silicone-carbon bond. Polyurethane

is a cross-linked polyester-urethane, prepared in

large commercial queantities using a continuous

foaming reaction process with the aid of catalysts.)

I was horrified. Suddenly much of what had happened to

me was being explained. The one thing it didn't

explain was why had Dr. Guichon not told me any of

this ? Why had he insisted that I was a very rare case

and convinced me that the problems I had were

exclusively mine ? He had never once explained that

they had possibly been caused by the implants. The

biggest shock was yet to come. The Meme implant did

not have a certificate of compliance showing it was a

safe device for internal use. Apparantly, legislation

requiring manufacturers to submit safety and efficacy

data regarding breast implants had not been introduced

into the Food and Drugs Act until October 1982.

Implants already on the market were exempt from this

legislation under a " grandfather clause " .

Grandfathering here means that new regulatory

requirements are not retroactive to products already

on the market. All breast implant devices which had

been sold in Canada, up to the date of the enactment

of the new regulations in April 1983, were not subject

to any of the new pre-market controls. According to

Dr. Blais, it was unclear whether the Meme fell into

this grandfather category, but the manufacturer was

claiming it did. We spoke for over an hour. Before

hanging up, Dr. Blais told me I could call him

anytime. I sat there, frozen with the words 'It was

not my fault'.

This article is an EXCERPT from 's book '

A Woman in My Position: the politics of breast implant

safety ', in which she discusses her own case and how

she (almost single handedly) uncoverd the huge

cover-up and deception in the Canadian MDA and the

American FDA involvement. To find out more about the

truth behind cover-up in Canada: read her book. Not

only is 's personal story interesting, but her

diligent efforts to expose the Canadian Government in

this 'big business practice' of covering up the

underhanded deeds of companies, such as breast implant

manufacturers, is to be commended.

===================Begin

MY NOTE - SEE:

Book

A Woman in My Position: the politics of breast implant

safety

http://www.cwhn.ca/search/pubRecord.htm?ObjectId=106622 & category=Breast%20Implan\

ts

Busted: cover-up involving breast implants

Network, Volume 1 No. 3, Spring 1998

(Ottawa) After eight years, the Royal Canadian Mounted

Police are investigating an alleged Health Canada

cover-up involving breast implants, the Toronto Star

reported June 4th. In 1990 , who after

suffering serious infections had to have both her Meme

implants removed, wrote to then-commissioner Norman

Inkster asking him to investigate why Health Canada

exempted Bristol-Myers Squibb's Meme implants

distributor from having to register the devices and

ensure their safety.

accused Real Lapperière Inc., the Quebec

distributor, of selling the implants without the

required registration. " No action has been taken

against him for failing to comply with the

regulations, " she wrote to Inkster in her February 6,

1990 letter. No one followed up on 's 1990

allegations, Constable Chartrand told the Star.

Eight years later, Chartrand's investigation will look

not only at Health Canada's regulation of the Meme

breast implant, but its regulation of all silicone gel

implants, including Dow Corning's devices. Dow

Corning's recently agreed to pay $2 billion (U.S.) to

women suffering health problems after having their

implants. About 25, 000 women had Meme breast

implants. Before 1993, when the government banned the

devices, around 150,000 Canadian women used silicone

gel breast implants.

( SOURCE -

http://www.cwhn.ca/network-reseau/1-3/pulse.html )

===================End

Legal Issues - Court Cases

Leaking or Ruptured Implants:

Two NY Judges appear to act as judge and jury !

October 21, 1996 NY - Judge Jack B. Weinstein of the

Eastern District, and Judge Harold Baer Jr in the

Southern District have made a ruling in New York that

will affect about 500 breast implant women. In an

unprecedented move the two judges ruled that claims of

localized symptoms from leaking or ruptured silicone

gel filled implants may proceed immediately to trial.

However, the judges said claims that defective

implants cause systemic diseases, such as connective

tissue disorders, wille be deferred until evidence on

the question of causation becomes clear from a panel

of experts appointed by Judge Pointer's court. Mr.

Weitz of Weitz & Luxemberg noted that localized

symptoms arise when silicone embeds in body tissue and

causes scarring and inflammation. In addition to pain

and deformity, scarring and infection can cause

complications such as kidney failure, cognitive

impairment and nerve damage. Both Weinstein and Baer,

in reviewing both sides' proof involving a link

between leakage and known diseases, concluded that

causation evidence was sufficiently wanting and that

" normally " a grant of summary judgement for all

claims, except local symptoms, would be appropriate.

However, the judges said that, " since scientists are

still developing relevant information " it would be

unfair to cut off plaintiffs' claims competely. They

suggested waiting for a report by the committe of

experts Judge Pointer appointed to access the

causation evidence, and possibly additional studies,

before finally ruling. Th claims with local symptoms

only are cleared to proceed to trial immediately with

the hudges even suggesting that claims for punitive

damages would be considered " when appropriate " . In

splitting the cases, the judges noted that the women

had already waited years to have their claims resovled

because of delays caused by federal class action and

related procedures.

[ Comment Editor - This is scary. When a hudge can

decide how sick you are based on who knows what

evidence - likely Dr. Angell's infamous book - and

your future health and well being is to be put in his

hands. If this sets a precedent for other state courts

we will have passed our lives and health from the

hands of the manufacturers, to the doctors, to the

attorneys, to the judges. So far, we have been the

only losers. All the above mentioned as well as the

news media, telephone companies, equipment sales of

fax, phones and computers have made money. The only

one left out is US ! I shudder to think of the jury or

judge trying to decide our cases based on our medical

records. Just how sick are you ? Even the doctors

can't figure this out, but the judge is going to ? I

know some women who have 5 to 20 pounds of medical

records ! Seldom are there two doctors who agree on

diagnoses or treatments. The scariest thing about this

is that we know our disease progresses and has a

latency periode of 10 to 20 years. Those women who are

not very ill now may be dead in a matter of a few

years ! Where is the money for their medical care to

come from ? Not from the pittance these judges are

going to award them ? Is this a setup for determining

Dow Cases ? I invite any attorney out there (we have

many on our mailing list) to comment on this latest

development ]

Legal Issues - Court Cases

Dupont & Teflon: TMJ Claims Dismissed

October 11, 1996 - The 8th U.S. Circuit Court of

Appeals deliverd a big victory to DuPont on october 4,

upholding a federal district court's ruling that the

chemical company could not be held liable for

supplying raw materials that were used in defective

TMJ joints. The MDL involving 280 federal lawsuits

were against DuPont who supplied Teflon products for

the Proplats TMJ implant. The Court's decision

encompassed all remaning federal lawsuits agianst

DuPont and effectively ends the company's TMJ

litigation in federal court, barring a Supreme Court

appeal. DuPont stopped supplying products to Vitek in

1989. The company was still subject to over 600

lawsuits from injured claimants who had received the

Proplast implant. The suits alleged that DuPont sold

the teflon products to Vitek and knew they were not

safe and did not warn physicians and patients of the

danger. The suits also alleged DuPont should be liable

in strict liability for the design defects because

they supplied the products to Vitek knowing it was

unsuitable for use in the implants. In the decision

written by Judge Pasco Bowman he wrote " while the law

of design defect clearly extends liability to finished

product manufacturers like Vitek, it rarely imposes

strict liability on component oart suppliers who

merely sell their multiuse parts to manufacturers of

finished products " . " In this case, the undisputed

facts show as a matter of law that the defect was in

the overall design of the implants and not in the

design of the FEP film. The recipients simply have

failed to show that the disintegration of the implants

was due to any design defect in the FEP film itself

rather than to Vitek's erroneous decision to

incorporate what turned out to be an unsuitable

material into its implants " .

===================B

My NOTE

DuPont fined for hiding Teflon dangers.

December 14, 2005 - AP (Associated Press)

Dover, Del. — DuPont Co. has agreed to pay $10.25

million in fines and $6.25 million for environmental

projects to settle allegations by the Environmental

Protection Agency that the company hid information

about the dangers of a toxic chemical used to make the

non-stick coating Teflon, officials said Wednesday..

http://www.theglobeandmail.com/servlet/story/RTGAM.20051214.wtefl1214/BNStory/In\

ternational/

===================E

Breast Implant Resolution introduced into House

The september issue of USSW NEWS carried a copu of

letters written by Representatives McIntosh and

Barbara Vucanovich which were designed to re-introduce

a bill relating to breast implants. On september 19,

1996 Representative McIntosh submitted the

following resolution, which was referred to the

Committe on Commerce. This is JUST a resolution, not a

bill, but it is important that we respond to it. We

must not let the members of Congress think for one

minute that we are going to sit idly by while we are

chopped up and thrown out with the shredded paper.

RESOLUTION

Relating to breast implants, the Food and drug

administration and public health.

- Whereas breast implant safety is a public health

issue of fundamental importance, particularly for

those women who are diagnosed with breast cancer and

who face urgent decisions about reconstruction and

women who already have implants;

- Whereas conflicting information has been provided to

the public about the safety of silicone gel breast

implants;

- Whereas the Food and Drug Administration imposed

restrictions on the availability and use of breast

implants, based primarily on cencerns of a possible

relationship between silicone gel breast implants and

connective tissue disease;

- Whereas breast cancer patients seeking

reconstruction may only gain access to silicone gel

breast implants through participation in a clinical

trial under an approved protocal;

- Whereas only a small fraction of the postmastectomy

patienst in the United States who week reconstruction

have access to silicone gel breast implants through

clinical trials;

- Whereas research has been undertaken in many

prestigious medical centers and universities on the

issue of silicone gel breast implants and connective

tissue disease;

- Whereas controlled scientific studies conducted by

these prestigious universities to date show no

clinically relevant risk of connective tissue disease

for women with silicone breast implants nor any

connection between the devices and systemic connective

tissue disease or classic autoimmune symptoms;

- Whereas the Food and Drug Administration has not

provided substantial information on breast care for

women with implants;

- Whereas the National Cancer Institute has not

provided substantial information on breast care for

women with implants, waiting for the Food and Drug

Administration lead in this matter; and

- Whereas the controversy over silicone breast

implants has a broader impact on the public health by

adversely affecting the supply of raw materials used

in other products, such as pacemakers, heart valves,

hip and knee joints, and artificial blood vessels:

Now, therefore, be it.

Resolved, That it is the sense of the House of

Representatives that the Food and Drug Administration

should take immediate steps to -

(1) ensure that women with breast cancer and other

women seeking breast reconstruction have enhanced

access to silicone breast implants; and

(2) eliminate requirements that these women

participate in clinical studies in order to obtain the

silicone implants. In addition, the Food and Drug

Administration should take immediate steps to resolve

the fears and concerns of women with breast cancer and

women who have breast implants by issuing a definitive

statement on the relationship or lack thereof between

silicone gel breast implants and connective tissue

disease, classic autoimmune symptoms, and other

serious diseases.

Legal Issues - Court Cases

3-M off the Hook....

A Memhis, Tennessee jury found in favor of 3M on

october 18, 1996. The jury took six hours to

deliberate after a five week trial. The spokesperson

commented that this is the second time in the past

that a jury found in favor of 3M: in a third case

tehre was a deadlocked jury. [ Comment Editor - Again,

what about the hundreds that were settled out of court

or won by the plaintiff? - I get so angry when I see

and hear of this one side reporting by supposedly

reputable papers. What happened to fair and unbiased

reporting. Thi paper is by design biased and it gives

more fair treatment to these cases than does the

" public press " ] Dr. Ley, spokesperson did make one

honest statement: " The safety of medical products

should be decided by legitimate scientists, not by

plaintiffs attorneys... " . The question is who is to

say what scientist are legitimate ? " Women, and the

general public, deserve the real facts about silicone

breast implants " . We agree - question is why won't the

manufacturers tell the truth ? The evidence is in the

public documents housed in the Federal Depository in

OH (Ohio), or don't they know that ?

====Note===========B

NOTE -

Bates Numbering Code for Documents in The Federal

Depository

( source - The Networker, June / July 1997 )

Networker has recently obtained diskettes and CD's of

documents on file in the Federal Depository in

Cincinnati, Ohio. The codes below reflect the filing

system.

ASP

Amercian Society of Plastic & reconstructive Surgeons

(ASPRS)

ASC

Applied Silicine corporation

BAX

Baxter Healthcare Corporation (includes Baxter

international, Baxter Healthcare, Heyer-Schulte,

American Heyer-Schulte & American Hospital Supply)

BPA - BPK - BPV - KK - VV

FFF - QQQ - BPB - BPL

BPW - LL - WW - GGG

RRR - BPC - BPM - BPY - MM

XX - HHH - SSS - BPD

BPN - AA - NN - YY - III

UUU - BPE - BPP - BB - PP

BZZ - JJJ - VVV - BPF

BPQ - CC - QQ - AAA - DD

KKK - WWW - BPG - BPR - RR

BBB - LLL - XXX - BPH - BPS

EE - SS - CCC - MMM- TT

YYY - BPI - BPT - GG - JJ

DDD - NNN - BPI - BPU

UU - EEE - PPP - BBC

Bioplasty, Inc. (includes Bioplasty, BioManufacturing,

& Uroplasty)

Note - The letter " BP " were added to all Bioplasty

documents which had a single alpha prefix to avoid

duplication of prefixes with other defendants)

MEA - MEE - MEI - MEM

MEQ - MEX - MEB - MEF - MEJ

MEO - MES - MEX - MEC

MEG - MEK - MEP - MET

BMS - MED - MEH - MEL

MEQ - MEU - BMB

Bristol Meyers Squibb Co. / medical Engineering

Corporation / Surgitek (Inclused all these, plus

Aesthetech, Markham Medical international, & Natural Y

Surgical Specialties).

CLF

Documents produced in the Californai State Ligigation

TCC

The companies, Inc. (includes The

Companies, Vision, Surgical, & CV Sub

1987)

CNG

Corning, Inc. (incluses Corning, Inc. & Corning Glass

Works)

CUI

-Uphoff International Inc.

TDC

The Dow Chemical Company

B - COM - D - H

KOP - M - P - CGS - CR

DCC - I - KPL - N - R

CIC - CRM - F - KCA - F - ? E

KPS - OOM - SP - CM - T

CSM - KCD - LOO - OOT

Dow Corning corporation, Dow Corning

corporation

QDC

Formerly Priviliged Dow Corning

KAA - KFD - KKA - KKE

KKM - KMM - KOC - KBZ

KHH - KKC - KKH - KKP

KMN

Dow Corning Bell documents

FDA

Federal Drug Administration

GEG GEP

General Electric company

HIM

Health Industry Manufacturer's Association (HIMA)

INM

Inamed corporation

IBV

Inamed V.B

KOK

Koken

MMM

3M - Minnesota Mining and Manufacturing

LTD

McGhan Limited

MCG

McGhan Corporation (The McGhan documents contain micro

film numbers with the alpha prefif " MC " or " MCG " . For

uniformity, all documents were coded with the alpha

prefix " MCG " and the microfilm number was used as the

identifying number.

MN

McGhan Nusil corporation

XMA - XMB - XMC - XMD

Mentor Corporation (Note - the letter " x " was added to

all Mentor documents to avoid duplication of prefixes

with other defendants documents)

POR

Porex

J

PSC Medical Articles CD

SCF

Scotfoam (includes 21 international Holdings, Knoll

International Holdings, Scotfoam, Foamex, L.P., foamex

Products, Reticel Foam Corporation, & " 21 " Foam

Company.)

SIR

Sirod Corporation

SSF

Specialty Silicone Fabricators

UCA - UCC - UCE - UCG - UCI

UCL - UCN - UCB - UCD

UCF - UCH - UCJ - UCM

UCP

Union Carbids

WFP

Wilshire Foam Products

===================E

USSW NEWS

- P.O. Box 683, Mena, AR 71953

- Phone: (501) 394-3995

- Fax: (501) 394-3999

- ISSN 1097-5691

- Shirley Goodner: Editor / Publisher

- International Distribution: Scotland, England,

France Australia, Holland, Canada, New Zealand,

Belgium, Switzerland ) - OUR PURPOSE - To assist men,

women, and children with silicone and saline implants.

To educate all people on the facts concerning these

implantable medical devices. To help all people become

informed. To give survivors and their families

support, and to help women empower themselves in their

own healing process.