Silicone Breast Implant Overview - Very long and comprehensive!

January 4, 2006

Thanks very much to a good friend of ours who sent

this:

I'll be archiving a copy of this. The copy should

retain the highlights that aren't visible here. . .

This is very comprehensive, long document that

deserves a thorough review. For those who haven't been

on the implant scene very long, it will bring you up

to speed very quickly!

I would like to thank Mr./Mrs. Eeken for all the work

they put into this!

Rogene

Overview ( 1989 - 2005 )

Silicone Breast Implants

By F. Eeken bc. Eeken_04@...

a non-professional investigative writer: just a

concerned citizen.

Europe, The Netherlands, december 2005

Introduction

Let's talk about breast implants !

Who were the first women to increase the size of their

bosoms ?

American women were not the first to try to enlarge

the size of their breasts from within. That

distinction belongs to the Japanese. The prostitutes

of post-World War II Japan catered to a large American

occupation force.....

http://www.eros-la.com/articles/2005-04-12/trivia0412/

Chronologic Summery of Silicone Breast Implants

http://www.pbs.org/wgbh/pages/frontline/implants/cron.html

Silicone Holocaust

http://www.siliconeholocaust.org

The Silicone Breast Implant Controversy

Articles -

- The Silicone Breast Implant Controversy: An

Introduction by Lany Donnelly

- A Chronology of the Silicone Breast Implant

Controversyd

- Memoir of a Junk Scientist , by B. M. Patten, M.D.

- Silicone Implant Disease , by Ron Kennedy, M.D.

- Silicone Gel Breast Implants: Were Proper

Disclosures Made ?, by D.P. , PhD., MBA

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

Pages of lany

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

The Other Side of the Story:

The Truth behind Breast Implants

What The Breast Implant Makers Don't Want You To Know

Personal Injury Lawyers, Dallas, Texas, Alice

McLarty, maryalice@...

Despite spending millions of dollars to portray

themselves as defenseless " victims, " the breast

implant makers cannot deny that the real victims here

are the thousands of women with implants who were

deliberately lied to and who are now suffering

debilitating illnesses. The facts are:....

http://www.maryalice.com/cases/implants.html

1989

Chemist Gets Fired After Calling Breast Implant Unsafe

Canadian scientist appeals his dismissal, charges the

agency that employed him with trying to stifle his

criticism of the product

The Scientist info@..., Volume 3, Issue

17, Page 7, Sep. 4, 1989

By Spurgeon - a freelance science writer based

in Ottawa.

OTTAWA—Research chemist J.J.B. Pierre Blais joined the

health protection branch of Canada's Department of

National Health and Welfare in 1976 in the midst of a

productive career in the federal science bureaucracy.

He had spent seven years at the National Research

Council, and looked forward to many more satisfying

years with his new agency. For a while it was just

that. An expert in the biocompatibility of implant

materials, Blais has worked on projects that have led

to amendments in Canada's Medical Devices Regulations

and served as section head within the department.

" He's a brilliant scientist who is always searching

for the truth, " says one of his superiors, Agit Das

Gupta. Blais also built a reputation as an innovative

and productive investigator, with some 180 published

articles, book chapters, patents, and monographs. But

six weeks ago Blais, at the age of 49, was fired from

his job. And he blames that same bureaucracy that had

employed him for 20 years for trying to stifle his

scientific criticism of a product that he and others

believe is unsafe............

http://www.pahealthsystems.com/printthread.php?threadid=122698

- Guidoin,Laval University -

robert.guidoin@...

- Montreal Gazette -

http://www.canada.com/montrealgazette/

SEE ALSO -

Health and Welfare's National Disgrace

Saturday Night Magazine, by Regush - April

1991

http://www.redflagsweekly.com/medevices.html

1991

Scientists Tie Breast Implant to Cancer

New York times, By Philip J Hilts , April 14, 1991

Scientists for the Food and Drug Administration have

determined that a kind of cosmetic breast implant that

hundreds of thousands of American women have received

over the last two decades breaks down in the body to

produce a substance that has been shown to cause

cancer in laboratory animals.

http://query.nytimes.com/gst/fullpage.html?sec=health & res=9D0CEEDC1338F937A25757\

C0A967958260 & n=Top%2fNews%2fHealth%2fDiseases%2c%20Conditions%2c%20and%20Health%\

20Topics%2fPlastic%20Surgery

Time Bombs in the Breasts?

Reports linking some types of silicone implants to

cancer stir fears -- but they may turn out to be

exaggerated - TIME, By Purvis- Apr. 29, 1991

, 49, was horrified. After a death-defying

battle with breast cancer and a prolonged recovery

that included reconstructive surgery, the Chicago

nurse learned last week that the very implant used to

repair her breast could raise her risk of developing

cancer once again...

http://www.time.com/time/archive/preview/0,10987,972846,00.html

U.S. Agency and its Critics Disagree

On Cancer Risk From Breast Implant

NEW YORK TIMES, By Blakeslee blakes@...

- May 16, 1991

In an effort to calm women alarmed over reports that a

chemical on some breast implants can cause cancer, the

Food and Drug Administration has sent a letter to

plastic surgeons saying that the lifetime cancer risk

from the implants is probably from 1 in 10,000 to 1 in

a million. But critics, including some of the agency's

own scientists, say the estimates are much too low.

...........

http://query.nytimes.com/gst/fullpage.html?sec=health & res=9D0CE1DE1F3AF935A25756\

C0A967958260 & n=Top%2fNews%2fHealth%2fDiseases%2c%20Conditions%2c%20and%20Health%\

20Topics%2fPlastic%20Surgery

1992

Stamping Out A Dread

By Barbara Ehrenreich - Feb. 17, 1992

In the spirit of a public health campaign, the

American Society of Plastic and Reconstructive

Surgeons (ASPRS) has launched a p.r. drive to " tell

the other side of the ((breast-implant)) story. "

Public health? Slicing women's chests open so that

they can be stuffed with a close chemical relative of

Silly Putty? Yes, indeed, because the plastic surgeons

understand what the FDA is so reluctant to

acknowledge: small breasts are not just a harmless

challenge to the bikini wearer or would-be topless

entertainer. They are a disease, a disfiguring illness

for which the technical term is micromastia..

http://www.time.com/time/archive/preview/0,10987,1101920217-159040,00.html

US halts breast implants

BBC, UK, 1992

The United States Government has advised doctors to

suspend the use of silicone breast implants pending an

investigation into their safety. The move has raised

fears around the world that silicone breast implants

could leak or rupture, causing injury or illness.

..............

http://news.bbc.co.uk/onthisday/hi/dates/stories/january/6/newsid_2477000/247790\

1.stm

Oprah Winfrey & Cosmetic surgery

The number one talk show, seen by an estimated 49

million US-viewers a week and broadcasted

internationally in 121 countries. Cosmetic surgery

became increasingly popular when Oprah Winfrey ran an

episode - " Plastic Surgeons Create Their Perfect

Wives " (20 April 1992) -

E.G. GUESTS ON O.W.-SHOW -

- A. Burns, CEO Dow Corning, liaison between

FDA / Dow Corning (1994)

- Sharon Green, Director National Breast Cancer

Organization (27 september 1995)

- L. Baker, physician among a select group

Board-certified plastic surgeons, testified 3x before

the FDA on breast implant related issues (hearings

1976, 1992, 2000), Clinical Research Investigator for

Liquid Silicone Injections for the FDA and Dow Corning

Corporation (1978 - 1981). From 1994 - 1996, he served

the National Institute of Health on breast implant

safety issue, appearence on O.W-Show in 1996 (each

show was on a breast related subject)

- Frederic H Corbin, Diplomate US Board Plastic

Surgery, US Society Plastic Surgeons

- Pearlman D. Hicks Jr., Chief Resident in Plastic

Surgery

- Dr. P. Bloch, plastic surgeon

- S. Hamas, M.D., Board Certified Plastic

Surgeon in Dallas

- Dr. , past president Minnesota Academy

Plastic Surgeons

- Kari Wuhrer, actress, had implants removed (2002)

- Dr. Pearlman D. Hicks, Beverly Hills Cosmetic

Surgeon

- Dr. Strock, private practice / Breast Implants

- Several People: addicted to Extreme Makeovers (8

february 2005)

National Cancer Institute Breast Implant Study

In 1992, researchers at the National Cancer Institute

(NCI) initiated a study on the long-term health

effects associated with silicone breast implants. It

is estimated that between 1.5 million and 2 million

women in this country have had breast implants since

they first appeared on the market in 1962.

One of the longest and largest studies to date on the

health effects of implants, the NCI report involves

13,500 women with an average follow-up time of 13

years. Most previous investigations have looked at the

health effects over a shorter time period, typically

less than 10 years, and have been too small to

evaluate uncommon diseases.....

http://www.cancer.gov/newscenter/siliconefactsheet

Series " Breast Implants "

Division of Rare and Manuscript Collections

Cornell University 2B Carl A. Kroch Library

Ithaca, NY 1485

Phone - (607) 255-3530

Fax - (607) 255-9524

rareref@...

http://rmc.library.cornell.edu

- Series List - Series II. Audiotapes: Boxes 8, 10-14

- Box 11 - Week of June 15, 1992 CLOSER LOOK Series

" Breast Implants " by Lloyd Gale

1993

Two doctors ordered to stop silicone injections:

Cosmetic surgery technique

FDA Consumer, March, 1993

by Judith E. Foulke jfoulke@... ?, FDA

spokeswoman, staffwriter

An undercover investigation by FDA's Los Angeles

district office led to court orders stopping two

California physicians from injecting patients with

liquid silicone for lip augmentation and other types

of cosmetic surgery, such as treatments for wrinkles

and acne scars. Liquid silicone is not approved by FDA

for any cosmetic surgical procedure.........

http://www.findarticles.com/p/articles/mi_m1370/is_n2_v27/ai_13560317

The trouble with implants: Links with disease

For thirty years plastic surgeons said silicone

implants were safe. Now women are rushing to have them

removed as researchers explore the links with disease

NEW SCIENIST, Katz - 26 June 1993

Panic has swept through millions of women with

silicone implants in the last few years - and not

without reason. Dozens of recipients have been

diagnosed with autoimmune disorders, the US government

has recently banned most implants because of doubts

over their safety, and manufacturers are now swamped

with lawsuits. But despite the legal brouhaha, crucial

medical questions remain unanswered. Do silicone

implants really cause immune disorders as the

anecdotal reports fuelling the lawsuits suggest? And

if so, how ?............ [ Subscription Required ]

http://www.newscientist.com/article.ns?id=mg13818794.700

1994

Sclerodermalike esophageal disease in children

breast-fed by mothers with silicone breast implants

Vol. 271 No. 3, January 19, 1994 - J. J. Levine and N.

T. Ilowite

Division of Pediatric Gastroenterology, Schneider

Children's Hospital, Long Island Jewish Medical

Center, Albert Einstein College of Medicine, New Hyde

Park, NY 11042.

OBJECTIVE--To determine whether breast-fed children of

mothers with silicone implants are at increased risk

for the development of sclerodermalike esophageal

involvement compared with children not exposed to

silicone implants.

CONCLUSIONS--A relationship appears to exist between

breast-feeding by mothers with silicone implants and

abnormal esophageal motility. Studies evaluating

larger numbers of children are needed to determine the

extent of the risk.

http://jama.ama-assn.org/cgi/content/abstract/271/3/213?maxtoshow= & HITS=10 & hits=\

10 & RESULTFORMAT= & fulltext=breast+implants & searchid=1128410605620_166 & stored_sear\

ch= & FIRSTINDEX=0 & journalcode=jama

Breast Implant woman diver Exploded

Minerva taken in by myth

BMJ, 11 june 1994;308:1574

Minerva reports that the breast implant of a woman

diver exploded during ascent from 30 m, causing major

injuries to her chest wall and fracturing two ribs.

http://bmj.bmjjournals.com/cgi/content/full/308/6943/1574/b

Implants may Lower Cancer risk

Harvard-Gazette Archives - 26 august 1994

In the past few years, silicone breast implants have

been one of medicine's most notable controversies

because of claims they cause crippling immune

disorders when they leak. Now research by scientists

at Massachusetts General Hospital suggests that

leaking implants may have yet another, quite

surprising, effect: They may provide some protection

against breast cancer......

http://focus.hms.harvard.edu/1994/August26_1994/BreastCancer.html

Silicone Breakdown and Capsular Synovial Metaplasia

in Textured-Wall Saline Breast Prothesis

By Copeland, Choi, Bleiweiss - Plastic &

Reconstructive Surg Jnl, Vol.: 94, No. 5, 628-633

October, 1994

Saline-filled prostheses are currently the only type

of prostheses available for cosmetic use in the U. S.

because of concerns raised about the possibility of

systemic toxicity of silicone-filled artificial

mammary implants. Although the approved implants are

saline-filled, their potential to release silicone

particles from the shells has not been systematically

evaluated. We performed microscopic examination of the

pericapsular tissue of 54 patients with

textured-surface implants and compared these with 51

patients with smooth- walled implants over a two year

period

http://womnhlth.home.mindspring.com/saline_implant/METAPLASIA%20IN%20TEXTURED-WA\

LL%20SALINE%20BREAST%20PROTHESIS.html

1995

Breast implant litigation faces uncertain future

Trial; 7 januari 1995 - Hellwege

Former breast-implant maker Dow Corning's bankruptcy

filing in mid-May 1995 leaves its $4.2 billion global

class-action settlement in question. The filing came

as all parties returned to the table following a

discovery that funds for immediate payments were

inadequate. The bankruptcy stays lawsuits against the

company, but plaintiffs can again file individual

lawsuits against other companies. Dow Corning parent

company Dow Chemical may also be liable, though judges

in some states have ruled otherwise........ [ Premium

article ]

http://www.highbeam.com/library/doc0.asp?docid=1G1:17332754 & dtype=0~0 & dinst= & aut\

hor=Hellwege%2C%20& title=Breast%20implant%20litigation%20faces%20uncertain%2\

0future. & date=07/01/1995 & refid=ency_botnm

SEE ALSO -

http://www.chron.com/cgi-bin/auth/story/content/chronicle/page1/97/08/26/implant\

s.2-1.html

The scandal of silicone implants

Green Left Weekly glw@...

By Dr Lynette Dumble ljdumble@... - senior

research fellow at the University of Melbourne's

Department of Surgery and a member of Feminist

International Network of Resistance to Reproductive

and Genetic Engineering (FINRAGE), Australia

December 1995

......Evidence in three landmark settlements -- US$4.2

billion against the implant manufacturing companies

Dow Corning, Bristol-Myers Squibb and Baxter

International in the US in 1994; another US$6 million

in 1995 to an Alabama woman who developed potentially

cancerous lumps and immune damage from rupturing

breast implants that spread silicone throughout her

body; and Bristol-Myers Squibb's out of court Can$28

million reserve for Ontario and Québec women suffering

any implant-attributed disease as a result of implants

supplied by its subsidiary Medical Engineering

Incorporated -- has uncovered the scandalous history

behind implant surgery....

http://www.greenleft.org.au/back/1995/214/214p3.htm

SEE ALSO -

- Dumble L 1996. Dismissing the evidence: The medical

response to women with silicone implant-related

disorders. Health Care for Women International. 17

(6): 515-525.

- Dumble L 1996. The scandal of silicone breast

implants. Women's Global Network for Reproductive

Rights Newsletter, (April-June): 25-26

Book -

Informed Consent

1995 ?

By A. Byrne - Byrne's " Informed Consent: A

Story of Personal Tragedy and Corporate

Betrayal...Inside the Silicone Breast Implant Crisis "

tells the wrenching story of and Colleen Swanson.

was a Dow Corning Corp. executive who shaped that

company's vaunted ethics program; Colleen, his wife,

had Dow Corning breast implants--but became more and

more convinced that they were destroying her health

and that the company had failed to inform women of the

risks. In time, like over 8,000 other women, she would

bring suit against the company--and would come to

believe that Dow Corning had acted unethically.

Byrne's account asks: What happens when a moral choice

separates you from your company's official position

and from your colleagues in a close-knit organization

?

The controversy surrounding silicone breast implants

has plunged Dow Corning Corp. into bankruptcy. More

than 8,000 women still have lawsuits pending against

the company, which has spent $1 billion defending

itself. On Sept. 13, a federal judge ruled that suits

against parent companies Dow Chemical Co. and Corning

Inc. could proceed despite the bankruptcy filing. All

this because of a product that produced less than 1%

of Dow Corning's revenues.

http://msnbci.businessweek.com/1995/40/b34441.htm

http://msnbci.businessweek.com/1995/40/b34442.htm

1996

Bristol-Myers Squibb wins Florida breast implant case

Trial; 3 januari 1996

A jury in ville, Florida, recently rejected a

woman's claims that she was injured by her breast

implants (Love v. Bristol-Myers Squibb Co., No.

94-238-CA (Fla., Duval County Super. Ct. Jan. 26,

1996). The verdict prompted the winning defendant to

urge other plaintiff to accept the settlement

currently offered by implant manufacturers rather than

take their chances in court. Bristol-Myers Squibb Co.

announced its victory in a press release the day of

the verdict...... [ Premium article ]

http://www.highbeam.com/doc/1G1:18130790/Bristol-Myers+Squibb+wins+Florida+breas\

t+implant+case%7eR%7e(Brief+Article).html

Beware: P.R. Implants in News Coverage

Mediawatch group FAIR, By Flanders

January/February, 1996

In 1985, Charlotte Mahlum received silicone breast

implants manufactured by Dow Corning. One ruptured,

leaking silicone into her breast, body and skin. Ten

years later, the 46-year-old former coffee-shop

waitress wears diapers. She has been diagnosed with

incontinence, hand tremors, atrophy in one foot and

brain lesions. She can no longer work; her husband has

to clean up after her. And on Oct. 28, eight men and

women voted unanimously in a Reno courtroom that Dow

Chemical was at least partly responsible for her

rapidly declining health........

http://www.fair.org/extra/9601/breast.html

Slight Risk of Connective-Tissue Disease

In Women With Breast Implants

JAMA 1996;275:618-625.

WESTPORT, Feb 28, 1996 (Reuters) - There may be a

small increased risk of connective-tissue diseases in

women who have breast implants, according to a report

in this week's JAMA. Dr. H. Hennekens of

Harvard and others reviewed data from the ongoing

Women's Health Study, which involves nearly 396,000

female health professionals. Some 10,830 of them

reported having had breast implants, and 11,805

reported having a connective-tissue disease......

http://list.mc.duke.edu/cgi-bin/wa?A2=ind9602 & L=occ-env-med-l & F= & S= & P=20760

)

No Major Hazard Found for Breast Implants

Harvard-Gazette Archives, By J. Cromie,

Gazette Staff

29 februari 1996

Breast implants do not put women at major risk for

crippling or lethal diseases, according to the largest

comparison to date of women who did and did not get

the grafts...

http://www.news.harvard.edu/gazette/1996/02.29/NoMajorHazardFo.html

Confidence Game:

Burson-Marsteller's PR Plan for Silicone Breast

Implants

Center for Media and Democracy - Publishers of PR

Watch

By C. Stauber and Sheldon Rampton - 1996

Once reviled as corporate villains, the manufacturers

of silicone breast implants have made a stunning

comeback recently in the court of public opinion. A

series of scientific studies and news stories have

emerged, arguing that breast implants are in fact

harmless, and that companies such as Dow Corning and

Bristol-Myers are hapless victims of misguided women,

greedy attorneys and manipulated juries. This

turnaround is no accident. PR Watch has obtained

internal documents from Burson-Marsteller, the PR firm

which engineered Dow Corning's PR strategy in the

early 1990s. These documents provide an intriguing

peek into a massive, expensive, and carefully

orchestrated campaign that integrates state-of-the-art

grassroots PR with subtle manipulations of science and

the legal process..

http://www.prwatch.org/prwissues/1996Q1/silicone10.html

PR Firm Finds " Grassroots " Support for Breast Implants

Mediawatch group FAIR, By Flanders

July/August 1996

It's no small thing to win a public relations fight. A

corporation under pressure benefits from the biases of

the profit-making news media, but the pro-corporate

leanings of commercial journalism don't guarantee

favorable coverage. What you need are

propaganda-generating troops, and if you have the

money, you can buy some.

http://www.fair.org/extra/9608/breast-implants.html

Trampling Science in a Rush to Judgment

Science on Trial - The Clash of Medical Evidence and

the Law in the Breast Implant Case

Marcia Angell, M.D. W.W. Norton -- 256pp -- $27.50

BUSINESSWEEK, By Naomi Freundlich - 1996

About a year ago, I started receiving mailings from

Dow Corning Corp., one of the primary manufacturers of

breast implants and the target of hundreds of

thousands of lawsuits from women who have gotten them.

Unsurprisingly, the clippings contained articles that

denied any connection between breast implants and the

terrible diseases they were accused of causing. At

first, I shrugged the material off as company

propaganda. But it wasn't much later that scientific

articles and a wave of news reports led me to begin to

question the accusations being made against implants.

Dr. Marcia Angell, the author of Science on Trial,

began her questioning back in 1992.....

http://www.businessweek.com/1996/33/b348827.htm

Epidemiology of Silicone Exposures

at ISEE meeting August 17-21, 1996 - Goldsmith

http://list.mc.duke.edu/cgi-bin/wa?A2=ind9601 & L=occ-env-med-l & D=0 & P=7943

Book " Science on Trial "

The most complete discussion of the issue of Breast

Implants. The Clash of Medical Evidence and the Law in

the Breast Implant Case - By Marcia Angell, M.D., also

author of ' The Truth About Drug Companies', former

executive editor of The New England Journal of

Medicine

Medical Evidence and the Law in the Breast Implant

Case

Civil Justice Memo - 28 August 1996

The breast implant scare is simply the most extreme of

a number of similar alarms that have swept across the

country over the last 20 years. Others have centered

on asbestos, DES, the morning sickness drug Bendectin,

the Dalkon Shield contraceptive device, Agent Orange,

and electromagnetic fields, to name just a few...

http://www.manhattan-institute.org/html/cjm_28.htm

When Courts Seek Help From Court Appointed Scientific

Experts

Courts, Communities and Scientists - September 1996

By Locke - plocke@...

The relationship between law and science has often

been strained, especially in lawsuits. In situations

where complex or emerging scientific theories are

involved, judges and juries can be overwhelmed by

technical issues. Typically, in such cases each side

hires its own scientist to support its theory of the

case. The lawsuit often becomes a battle of the

experts; juries and judges, who have limited

scientific training, are then forced to assess the

credibility of the experts (and what they have said)

in reaching a verdict. In federal courts there is a

different way of obtaining and using scientific

expertise. The Federal Rules of Evidence empower

judges to appoint experts to advise the court about

the scientific issues. These experts do not represent,

and are not hired by, either party and therefore, the

theory goes, they are likely to be more forthcoming in

giving " objective " advice. Although this rule has

existed for some time, it has not been frequently

used. Recently, however, at least one judge has

decided to try it. District Judge Sam Pointer, who

sits in Birmingham, Alabama, is putting together a

panel of " neutral " experts to analyze the studies of

the health effects of silicone-gel breast implants....

http://sehn.org/Volume_1-6.html

" Whom Do You Trust ?

( SOURCE - Commentary, Washington Post, 30 December

1996, A11 )

Columnist Harwood discusses the recent Oregon

court decision to limit the testimony of expert

witnesses in a silicone breast implant trial. He

broadens the scope of his discussion to the

reliability of scientific methods and variance among

scientific experts, reminding journalists to be

skeptical, " recognizing that `expert' opinion is not

necessarily `truth' and often has a short shelf life. "

In the course of his discussion he mentions current

scientific controversies over global warming; Love

Canal, toxic waste and birth defects; Agent Orange and

health effects; Gulf War Syndrome and nerve gas

exposure; apples and cancer.

1997

Study tracks complications linked to breast implants

March 5, 1997

ROCHESTER, Minnesota (CNN) -- Almost one out of five

women with breast implants had to return to the

operating room within five years to fix problems with

the implants, Mayo Clinic researchers said in a study

published Wednesday. ......

http://www.cnn.com/HEALTH/9703/05/briefs.pm/implants/

Failure properties of leaf valve inflatable saline

breast implants

- Division of Plastic Surgery, Wellesley Central

Hospital and the University of Toronto, Toronto,

Ontario - Walter s PhD MD FRCSC

walter.peters@...

- Can J Plast Surg 1997;5(4):241-245

In 1963, Cronin and Gerow (1) introduced the Silastic

(silicone gel, Dow Corning, Tennessee) breast implant,

opening the new era of breast augmentation surgery.

This original 'Cronin' implant was made of a thick gel

contained in a thick, rigid, elastomeric envelope,

which had a Dacron (Dupont, Delaware) backing on the

posterior surface to anchor the implant to the chest

wall to attempt to reduce ptosis. It was available in

only a limited number of sizes. Many women who

received these implants developed early and severe

capsular contracture (1,2). ......

http://womnhlth.home.mindspring.com/saline_implant/pete_ed.htm

New inquiry into breast implant safety

Daily Telegraph , By Celia Hall chall@...

, Medical Editor

30 May 1997

Lady Jay, the health minister, has ordered an inquiry

into the safety of silicone breast implants following

criticism during a television programme last night.

She told Sir Calman, the Chief Medical

Officer, [ Note present - former Chief Medical

Officer, now Vice Chancellor at Durham

kenneth.calman@... ,

vice.chancellor@... ] to set up an inquiry

yesterday, even though the Health Department has twice

said that implants are safe. BBC's Watchdog

watchdog@... Healthcheck investigated women who

claim they have side- effects from silicone implanted

in breasts, cheeks, chins and lips. In some cases the

silicone was said to move around the body after an

implant ruptured.........

http://www.telegraph.co.uk/htmlContent.jhtml?html=/archive/1997/05/30/nsili30.ht\

ml

Testimony at Silicone-Implant Hearing

Apparently Fails to Prove Link to Illness

( SOURCE - Technology & Health, Wall Street Journal,

25 July 1997, B3 )

An expert panel of four doctors has not been convinced

by scientific testimony seeking to prove a link

between silicone breast implants and immune-system

illness. The trial is taking place in the Birmingham,

Ala., courtroom of U.S. District Judge Sam C. Pointer

Jr., " who has taken the novel approach of directing

the panelists, after considering all the evidence, to

give video-taped depositions. They will serve as

neutral, court-appointed experts in potentially

thousands of future silicone cases--and very likely

will determine the course of much of the litigation. "

Among the scientists mentioned as testifying: Lu-Jean

Feng of Case Western Reserve University; S.

Sergent of Vanderbilt University; Anarnol Starr of

University of California at Irvine; and Sander

Greenland of University of California, Los Angeles.

I. Kervliet of Oregon State University is one of

the panelists.

U.S. Survey Clears Silicone Implants of Role in Breast

Cancer

AP - September 17, 1997

Washington - Silicone breast implants do not cause

breast cancer, according to a Federal review of scores

of medical studies.

http://www.nytimes.com/specials/women/warchive/970917_640.html

Breast Implants as Beauty Ritual: Woman's Sceptre and

Prison

1997 - Yale Journal of Law and Feminism - M.

Spanbaue 7spanbau@... ?

Taught from their infancy that beauty is woman's

sceptre, the mind shapes itself to the body, and,

roaming round its gilt cage, only seeks to adorn its

prison

http://www.jmls.edu/facultypubs/spanbauer/breast_implant_l_rev.shtml

Doctors warn of breast implant leaks

Daily Telegraph, By Celia Hall, Medical Editor

21 November 1997

Almost all silicone breast implants will rupture and

leak when they have been in place for 20 years,

doctors say today. They warn women to think carefully

before having breast enlargement surgery. A summary of

research studies in The Lancet says only five per cent

of women can expect to have both implants intact after

20 years, only 51 per cent after 12 years and 89 per

cent after eight years.

http://www.telegraph.co.uk/htmlContent.jhtml?html=/archive/1997/11/21/nboo21.htm\

l

Silicone Breast Implants and Neurologic Disorders

Report of the Practice Committee of the American

Academy of Neurology

Neurology 1997;48:1504-1507

......Conclusions. The best observational studies to

date (some retrospective cohort and case control

studies [Class II]) show no clear relationship of

silicone breast implants to connective tissue disease.

Research in this area is ongoing. Existing studies

(some case series--Class III) do not support any

association or causal relationship between silicone

breast implants and neurologic disorders. If such a

relationship exists, we must await proper

observational studies, preferably prospective cohort

studies, or less preferably, case control

studies......

http://www.aan.com/professionals/practice/guideline/index.cfm?fuseaction=home.vi\

ew & guideline=89

Library of Congress

50 Congressional Record articles, 1997 - 1998

http://thomas.loc.gov/cgi-bin/query/r?r105:@phrase(breast+implant)

1998

Silicone Gel Breast Implany - Civil Action

United States Districy Court Alabama - Sandy

Altrichter

June 2, 1998

http://earth.fjc.gov/BREIMLIT/ORDERS/inamed.wp5

Paper ?

" Expert Games in Silicone Gel Breast Implant

Litigation, "

in Freeman and Reece, eds., Science in Court (London:

Darmouth, 1998),

By Sheila Jasanoff - sheila_jasanoff@...

Kennedy School of Government Faculty

Curriculum Vitae -

http://ksghome.harvard.edu/~sjasanoff/SJ-CV-2004.pdf

Scientific evidence:

Silicone breast implants can produce autoimmune

illnesses.

The Light Party freedom@...

Dedicated to " Health,Peace & Freedom for All " - 1998

......Now, 36 years later, it is alarmingly apparent

that bigger, siliconized breasts can be hazardous to

your health. Weíre beginning to see that the real cost

of cosmetic breast enhancement may not be the $6,000

in surgical fees to implant them, but a host of

autoimmune symptoms and strange illnesses that can

crop up, typically within about seven years of

implantation........

http://www.lightparty.com/Health/SiliconePoison.html

E-mail: Breast Implants and Breast Cancer

From - Professor Norman Levitt (Mathematics , Rutgers

University)

Date - Thu, 25 Jun 1998 20:54:09 -0400

Reply To - Sci-Cult Science-as-Culture

Sender - Sci-Cult Science-as-Culture

Subject - " Nation " on G. B. Kolata II

[ Note - B. Kolata, science writer, New York

Times - kolata@... ]

The topic she chose was silicone breast implants.

Breast implants are a contrarian's dream topic because

there are two distinct sides, both of which have

sharpened their arguments during ten years of massive

litigation against Dow Corning, Bristol-Myers Squibb

and other manufacturers of the product. Pick either

side and you're a contrarian. Stories from the middle

ground get less attention...

http://human-nature.com/science-as-culture/SCI-CULT%20LOG9806.txt

Neurologic illness related to breast implants

by H. Ferguson MD

jferguson@..., Neurology 1998

......Before the current issue of Neurology, there had

been no published epidemiologic studies of neurologic

illness related to breast implants. However, there

have been several retrospective cohort studies testing

the hypothesis that silicon breast implants are

associated with various autoimmune disorders...

http://www.pbs.org/wgbh/pages/frontline/implants/medical/ferguson.html

European Commission Guidelines Implants

Guidelines for conformity assessment of Breast

Implants -

Acoording to Directive 93 / 42 / EEC relating to

Medical Devices - July 1998

http://europa.eu.int/comm/enterprise/medical_devices/meddev/2_5-7____07-1998.pdf

Breast implant operations increase, despite

controversy

CNN, July 8, 1998

Women are getting breast implants in record numbers,

despite the negative publicity the surgery has

received in recent years.

http://www.cnn.com/HEALTH/9807/08/implant.boom/

An Atypical Complaint:

Science v. Subjectivity in Breast Implant Litigation

Making People: The Normal and Abnormal in

Constructions of Personhood

Xandra Rarden xrarden@... ? and Sheila Jasanoff

sheila_jasanoff@...

Cornell University - July 1998 ?

Abstract - Competing scientific accounts have emerged

in the debate over whether silicone gel breast

implants cause autoimmune disorders. The mainstream

story, told principally by epidemiological researchers

at leading medical institutions, denies any causal

connection between the devices and traditional forms

of the disease. The alternative story, told by

plaintiffs and their treating physicians, posits the

existence of an " atypical " disease, whose symptoms are

fully understandable only to those willing to heed the

plaintiffs' subjective experiences. In this paper, we

examine the scientific contestation around the

attempted construction of an " atypical " disease

entity. We ask how the cultural context of litigation

molded and shaped the mainstream and alternative

scientific stories, influencing the production of

different forms of collective knowledge. Interactions

among judges, lawyers, scientists, doctors, the media,

and social activists all contributed to this process.

We show how mainstream science eventually ratified the

safety of the implants, while discarding or setting

aside the alternative hypothesis. Although a powerful

social movement coalesced around the " atypical "

disease claims, knowledge derived from personal and

group experiences failed to make headway against the

claims of objective science. Yet, allowing orthodox

scientific practice systematically to dominate over

other types of meaningful knowledge production may not

be the best the way to bring closure to such

controversies. Instead, we need to search for

mechanisms that strike a better balance between

scientific and subjective knowledge in toxic tort

litigation.

( SOURCE -

http://human-nature.com/science-as-culture/SCI-CULT%20LOG9807.txt

)

UK Minister of Health

Report Silicone Gel Breast Implants " No evidence

disease "

The Report of the Independent Review Group (IRG)

Professor D Sturrock

RDSturrock@...

July 1998

http://www.silicone-review.gov.uk/silicone_implants.pdf

http://www.silicone-review.gov.uk

Jury still out on silicone breasts

BBC, UK - July 13, 1998

A government panel has rejected claims that silicone

breast implants cause long-term sickness, but has

called for stricter controls over their use...

http://news.bbc.co.uk/1/hi/health/latest_news/131994.stm

Breast implants are cleared of causing Disease

Daily Telegraph, By Celia Hall, Medical Editor - 15

July 1998

The Government accepted a package of recommendations

yesterday to regulate silicone breast implant surgery

and protect the 8,000 women who seek the cosmetic

operations every year.

The independent review ordered by Baroness Jay, the

health minister, could find no scientific evidence to

link the silicone implants with abnormal immune

response or the development of diseases such as

arthritis, as has been claimed..........

http://www.telegraph.co.uk/htmlContent.jhtml?html=/archive/1998/07/15/nbre15.htm\

l

Statement on the safety of silicone Breast Implants

Public Citizen's Health Research Group

Statement before the Institute of Medicine of Sidney

M. Wolfe, M.D.,

July 24, 1998

Breast implants are now in their fourth decade of use,

no regulations for pre-market safety testing having

been in place when they were first marketed. Studies

which should have been done long ago are only now

being done, well after most of the approximately two

million women had their implants. Of 1135 published

studies in the National Library of Medicine database

under the search terms " silicone implants " and

" adverse effects " , 387 or only 34% were published

between 1966 and 1989, a 24-year interval. 748, or 66%

were published in the past 8+ years (1990 to

now).......

http://www.citizen.org/publications/release.cfm?ID=6646

New Report on Silicone Implants May Not Tell Whole

Story

ABCNEWS.com, By McKenzie health@...

1 december 1998 ?

A panel of scientists appointed by a federal judge has

just announced that it found no proven links between

silicone implants and the illnesses of hundreds of

thousands of women who have sued implant makers. The

FDA found potential manufacturing problems that could

result in implants more likely to

rupture.....(...).....The Mentor Corp.'s plant in

Irving, Texas, is a major producer of breast implants.

Government documents obtained by ABCNEWS show that

over the past 12 years, since 1986, the FDA has

repeatedly accused Mentor of inadequate quality

controls...

http://womnhlth.home.mindspring.com/should_read/Implant%20Safety%20Revisited%20.\

htm

Panel can't link Breast Implants to Any Disease

By Kolata kolata@... - December 2, 1998

A panel of four scientists, appointed by a Federal

court, issued a report yesterday concluding that

scientific evidence has so far failed to show that

silicone breast implants cause disease......

http://query.nytimes.com/gst/fullpage.html?sec=health & res=9B02E5DC153BF931A35751\

C1A96E958260 & n=Top%2fNews%2fHealth%2fDiseases%2c%20Conditions%2c%20and%20Health%\

20Topics%2fPlastic%20Surgery

The Breast Implant Study

Has Produced Differing Opinions Letters

Washington Times, 14 December 1998, A18.

Three letters commenting on recent silicone breast

implant stories. Writers are Sally Pickett of

ez, Calif., Leonard A. Schneider of Whites

Plains, N.Y., and Whitford of Pitkin, La.

http://list.mc.duke.edu/cgi-bin/wa?A2=ind9812 & L=occ-env-med-l & D=0 & P=8410

1999

A report to the Mass Torts Working Group

Federal Judicial Center - R.Spiro, C.Witcher,

P.Egelston, S.Hruby & M.Deckman Fallon

January 1999

This report was undertaken at the request of the Mass

Tort Working Group and is in furtherance of the

Center's statutory mission to conduct and stimulate

research and development for the improvement of

judicial administration......At its inception in

February 1998, the Mass Torts Working Group (MTWG)

asked the Federal Judicial Center to assist it by

identifying the major mass torts that courts had faced

in modern times and looking at the individual

characteristics of such cases to see if any patterns

emerge.....Silicone gel breast implants, 53 ......

Part 1-A summarizes, one by one, the 26 major

product-based mass injury case congregations, such as

asbestos, breast implants......

http://www.fjc.gov/public/pdf.nsf/lookup/MassTApD.pdf/$file/MassTApD.pdf

Breast implants kill mice

BBC, UK - February 11, 1999

The silicone used in breast implants can kill mice,

scientists have found. They also found that the

silicone can leak out of intact implants, increasing

fears that the devices put women's long-term health at

risk...... LINKS / Related Stories -

02 Dec 1998 - Silicone implants safe says US inquiry

09 July 1998 - US : Settlement reached in breast

implant case (Dow Corning Corporation)

06 febr 1998 - Breast implants 'safe'

19 Dec 1997 - Breast implant leak risk 'far higher

than suspected' (The Lancet / FDA)

http://news.bbc.co.uk/1/hi/health/277602.stm

Soyabean breast implants banned

Stocks withdrawn as Government decides more research

is needed

The Guardian, By Boseley

sarah.boseley@..., Health Correspondent

March 9, 1999

Breast implants filled with soyabean oil, chosen by

thousands of women because of the panic surrounding

silicone, were banned by the Department of Health

yesterday amid concerns for their safety....

http://www.guardian.co.uk/uk_news/story/0,3604,315648,00.html

Sick ? Cause Silicone Breast Implants

Lemon Tort - Nevada's Supreme Court Upholds Junk

Science

Nevada Journal, Volume 7, Number 4 , April, 1999

by D. Dowd Muska ddm@...

Charlotte Mahlum is a very sick woman. The former Elko

resident suffers from severe headaches, seizures, loss

of muscle control, exhaustion and tingling sensations

throughout her body. And she's convinced—as are

thousands of women with similar symptoms—that her

condition has a single cause: silicone breast

implants........

http://nj.npri.org/nj99/04/feature.htm

Fairness, Accuracy and the Tyranny of the Anecdote

Science beat challenges reporters seeking to

understand research findings

FACSNET, By Kolata, Reporter, Science

kolata@... - April 1999

The first time I wrote about silicone breast implants,

I had a more than just a hunch about where the truth

lay. I would have bet, if anyone had asked me, that

implants can cause serious diseases.

http://www.facsnet.org/tools/nbgs/a_thru_h/f/fairness.php3

Asthma in Patients with Silicone Breast Implants:

Report of a case series and identification of

Hexachloroplatinate contaminant as a Possible

Etiologic Agent

R Harbut, C Churchill - IJOH 1999;

3:73-82

- Center for Occupational and Environmental Medicine,

Wayne State University

- School of Medicine, Detroit, Michigan, and

- Department of Internal Medicine, Providence

Hospital, Southfield, Michigan

ABSTRACT

The following study is of 8 breast implant patients

evaluated because of respiratory systems, pruritus and

rhinorrhea. The presence of hexachoroplatinate in the

implants was notes and support for the hypothesis that

this contaminant was related to the symptoms

experienced by the patients is presented. Cases of

implant related asthma were defined by episodic

dyspnea, cough, or breathlessness with onset or

worsening after implant placement and objective

evidence of reversible airways obstruction, either

during the presence or after the removal of the

devices. All eight patients were found to have asthma,

with airway hyper-reactivity demonstrated by

methacholine challenge testing performed in seven

patients and by partially reversible obstruction after

nebulized administration of a beta-agonist in one

patient. Eight patients had urticaria and seven had

rhinorrhea. Eight of eight breast implant patients

evaluated had findings consistent with asthma.

Hexachloroplatinate, a potent sensitizer and component

of breast implants, is identified as the likely

primary etiologic agent in view of findings consistent

with platinosis in thesepatients, and the

demonstration of the leaching of hexachloroplatinate

from even intact silicone breast implants.

(SOURCE-

http://list.mc.duke.edu/cgi-bin/wa?A2=ind9901 & L=occ-env-med-l & D=0 & P=14678)

Breast implant plaintiffs say scientific panel was

tainted

Ask for findings to be invalidated

April 13, 1999

BIRMINGHAM, Alabama (CNN) -- A motion was filed

Tuesday to terminate a court-appointed science panel

evaluating the safety of silicone breast implants, and

invalidate its findings due to conflict of interest by

one of the four scientists...

http://www.cnn.com/HEALTH/9904/13/breast.implant.panel/

Another Study Clears Silicone Breast Implants

They're still a big risk, says panel, but not a cause

of killer diseases

TIME, By Alain L. - Jun. 21, 1999

Vignette StoryServer 5.0 Fri Dec 30 21:29:28 2005 The

legal repercussions of failed silicone breast implants

may not be over, but the medical studies are becoming

increasingly consistent. The latest, released on

Monday by the Institute of Medicine, an arm of the

National Academy of Sciences, confirms the emerging

consensus: Medical evidence does not support the

contention that silicone breast implants cause major

life-threatening diseases......

http://www.time.com/time/nation/printout/0,8816,27224,00.html

2000

Comprehensive study: No systemic Breast Implant

dangers

on david_williamson@... , University

North Carolina - 14 March 2000

(Embargoed) CHAPEL HILL - The largest, most

comprehensive study done to date of the possible link

between silicone breast implants and connective tissue

diseases has found no evidence that the implants

impair women's health. ..........

http://www.eurekalert.org/pub_releases/2000-03/UoNC-Csrn-1403100.php

Meta-analyses of the Relation Between

Silicone Breast Implants and the Risk of Connective

Tissue Diseases

The New England Journal of Medicine, (Volume 342,

Number 11)

Janowsky E, Kupper L, Hulka B, 16 march 2000

For each of the conditions analyzed, the findings

provided no evidence of an association between breast

implants and specific or combined connective-tissue

diseases.

http://www.medscape.com/viewarticle/419145_print

Breast Implants limit detection breast cancer

MEDSCAPE, G. Bradley, Jr, MD, PhD, FACR, 2000

http://www.medscape.com/viewarticle/412981

EC in silicone implants inquiry

BBC, UK - 23 May, 2000

The European Commission is to investigate the use of

silicone implants in cosmetic surgery in response to a

campaign started by a Glasgow woman. Norris

says the silicone in her breast implants has leaked,

poisoning her body and ruining her health......

http://news.bbc.co.uk/1/hi/scotland/760735.stm

EU may crack down on breast implants

BBC, UK, 24 May 2000

Legislation governing the health and safety of breast

implants is to be considered by the European

Commission. The move comes after a five year campaign

by a Euro-MP to raise awareness of the potential

dangers of silicone implants. ........

LINKS / Related Stories -

19 May 2000 - FDA " Huge rupture rate in breast

implants "

(see also on this -

http://imaginis.com/breasthealth/news/news5.25.00.asp

)

08 Mar 1999 - Breast implants withdrawn

21 June 1999 - Breast implants 'do not cause serious

disease'

http://news.bbc.co.uk/1/hi/health/761749.stm

Implant: 'A nightmare from beginning to end'

BBC, UK - 6 June, 2000

As the government advises the removal of breast

implants containing soya bean oil, one of the 5,000

women who have received them explains how her health

has been affected. Lynsey Irvine, 24, from Edinburgh,

had the implants put in in December 1997 for cosmetic

reasons...........

http://news.bbc.co.uk/1/hi/scotland/780097.stm

Firm to fund breast implant removal

BBC, UK - 6 June, 2000

The manufacturer of soya-filled breast implants, which

women have been recommended to have removed, has said

it will pay for the new operations. The Department of

Health said on Tuesday the risk that the implants

could cause cancer or harm an unborn baby could not be

ruled out......

http://news.bbc.co.uk/1/hi/health/779346.stm

Inamed Wants Silicone Back In Breast Implants

Herper, Forbes.com, 13 june 2000

It's been eight years since the U.S. Food and Drug

Administration banned silicone breast implants, but

the desire among women to boost their bust size hasn't

gone away. In the midst of a nationwide health scare,

the FDA banned silicone implants in 1992. Since then,

most implants are made of either saline or, more

rarely, soybean oil. But Ilan Reich, co-CEO of Inamed

imdc (nasdaq: imdc - news - people), is betting that

silicone implants will make a comeback.....

http://www.forbes.com/2000/06/13/feat.html

? Breast implant infection in a cat owner due to

Pasteurella multocida

July 2000 - Journal of Infection, Volume 41, Issue 1 [

User Name and Password ]

http://www.sciencedirect.com/science?_ob=ArticleURL & _udi=B6WJT-45F4XY3-1S & _cover\

Date=07%2F31%2F2000 & _alid=349839321 & _rdoc=1 & _fmt= & _orig=search & _qd=1 & _cdi=6887 & _\

sort=d & view=c & _acct=C000050221 & _version=1 & _urlVersion=0 & _userid=10 & md5=2abe00c35\

f7db3d68e866a6d3c0b7d9b

Spanish women to sue over breast implants

Xavier Bosch, Barcelona - BMJ 12 august 2000 ;321:403

Twenty Spanish women with soya oil breast implants are

to sue the UK based manufacturer, AEI, and its

Barcelona based importer, Colagen Biomédica, after

being advised that they should have the prostheses

removed...

http://bmj.bmjjournals.com/cgi/content/full/321/7258/403

Implant Firm is Probed after U.S. Ban

Health experts move in to Scots plant after scathing

reports on safety and hygiene

28 August 2000 , Daily Record, UK

A breast implants factory in Scotland is being

investigated by the Government. Health experts will

this week rake over records and procedures at the

plant. The parent company is being taken to court by

three Scotswomen whose implants ruptured, causing

catastrophic health problems. Products made by Biosil

Limited have been banned from sale in the States after

a damning report by US inspectors. Despite the US

refusal of a licence, however, implants made at the

Biosil factory in Cumbernauld since 1990, are still

widely available on the NHS. Biosil and parent company

Nagor, who distribute the implants, are at the centre

of a number of legal battles. Both companies have been

linked to implant scandals around the world stretching

back to the early 80s. And three Scotswomen claim they

were put at risk of cancer and other devastating

illnesses when Nagor implants ruptured inside them. A

team of US government scientists visited Biosil's

factory on the Westfield Industrial Estate,

Cumbernauld, in April this year ( SOURCE -

http://www.bnn-online.co.uk/news )

Immediate European Parliament ban on silicone implants

Letter from - Committee Environment, Public Health and

Consumer Policy

http://www.europarl.eu.int/committees/envi_home.htm

To - The chairman of the Committee on Petitions

Brussels, 30 August 2000

....In March 1999 after many years of campaigning, two

petitions calling for an immediate European Parliament

ban on silicone implants were tabled by self-help

groups of women who claimed to be suffering adverse

effects from silicone-gel breast implants. The

Parliament has now responded by asking for formal

replies to the Petitions Committee and seeking the

counsel of the Environment Committee, the Committee on

Women's Rights and the Committee on Research..

http://www.europarl.eu.int/meetdocs/committees/envi/20000911/417110_en.doc

Breast implant advice from government

BBC, UK - 4 October, 2000

Women considering having breast implants are to have

access to objective advice from a booklet written by

the Department of Health. The booklet aims to ensure

women have all the information they need before

surgery, while the debate about the safety of implants

continues. Its release coincides with publication of

research from the US National Cancer Institute which

concludes that having implants is not linked to breast

cancer risk....

http://news.bbc.co.uk/1/hi/health/956247.stm

One in seven breast implant patients have

complications

The Independent - 5 October 2000

By Cherry Norton c.norton@... ?, Social

Affairs Editor

One in seven women experience problems after breast

implant operations, says a government booklet

detailing the dangers. For the first time women are

being provided with information about the risks

attached to each of the different types of breast

implants available. The booklet, published by the

Department of Health today, will be distributed to

clinics, doctors and patient support groups. The

information covers the four types of breast implants

available in the UK: Silicone Gel, Saline, Hydrogel

and Polyvinyl pyrolidine solution (PVP). The booklet

quotes recent evidence in Britain suggesting that one

in 10 women with breast implants has had a problem

with a hardening of the implant, which causes it to

deform and in some cases become painful. (SOURCE-

http://www.bnn-online.co.uk/news_datesearch.asp?SearchDate=05/Oct/2000 & Year=2000

)

Scandal of Killer Medical Aids

German company linked to injuries of British patients

15 October 2000 The Observer, UK

In August, 29-year-old accountant Jan Temple responded

to a Department of Health urgent warning and had her

soya oil breast implants removed. She had learnt that

they could cause cancer, kill foetuses and harm

breastfeeding babies. The complex and unpleasant

operation left her without movement in part of her

right arm. Because the soya is a natural product it

becomes entwined with the breast tissue and the

implants have to be 'ripped out', which can take more

than five hours. In many cases the soya becomes putrid

and the rancid remains have to be treated as a

biological hazard. So far, 1,400 women in Britain have

faced this horrific ordeal. But the full story of how

thousands of women have been emotionally and

physically scarred by these implants is only likely to

come out in a US court next year when their American

manufacturer faces compensation claims. At the same

time, the case will shine light on how faulty medical

technologies can easily find approval for use in

Europe

( SOURCE - http://www.bnn-online.co.uk/news )

---------------------------------------------------------------

[ free translation ]

Breast - Implants

Dutch Support-Point for women with siliconen implants

(SVS)

The foundation SVS is an interest-organisation for

women with questions concerning and/or problems by

silicone implants, human adjuvant disease (HAD),

silicone related disease (SRD). The foundation gives

telephone and written information and offers relief.

Also she examines the possibilities for prevention and

medication. Mission of the SVS - the SVS strive for a

prohibition on unlimited use of

silicone-gel-filled-implants, the promotion of

research, an aid programme for the patients and

prevention

Mrs. Marlou Boots

Uitdamstraat 22, 8244 DZ Lelystad Haven

Europe, The Netherlands

- Tel - +0031- 320-264566

- Fax - +0031 - 320-264548

- Homepage - No website yet

This Article was earlier published in magazine 'De

Stille Kracht' (The Quit Power) published by SVS.

Silicone litteraly take possession of your body.

Marketing inventions, which greedyly are taken up by

the medical science. There is then not thought that a

crime is being committed on the human body. Marlou the

founder of Support Point for Women with Silicone

Implants (SVS) tells her own story. A story not only

to think about, but litterally yo stand still by.

In 1991, I had my last pocket silicone removed. I was

after 18 operations more dead than living. I recovered

quit a bit and and started to deepen myself into

silicone-literature. Already quickly it became clear

to me what the cause had been of my lost years and I

placed an add in the newspaper in which I sought

fellow-sufferers. The responses was overwhelming and

in 1992, I set up the Support Point for Women with

Siliconen Implants (SVS). I have answered thousands of

phone calls since that time. I have a collection of

implants in several states of dissolution, which

scares the hell out of you. With the SVS I am

meanwhile busy at international level. It is a pity

that women let them talk into such a negative

self-image. My motto is: " rather flat than a plants " .

The ground substance of silicone is silicate-rock

(sand). For the filling of prosthesis this undergoes a

chemical treatment as a result of which a substance

arises that is similar to 'Bison kit' ( brand of a

strong thick glue). In principle you can state that

implants always keep perspiring, sweating. As a

result, the very small particles of those 'Bison kit'

are distributed by means of our lymfatisch sytem

through the body. With the duration of alwaus sweating

it concerns small quantities, but if the implants are

going to leak there will come an overdose of silicon

in your body. Compare this with a considerable amount

of 'Bison kit' on your carpet. It can be no longer

cleaned. Silicon, float, they spread themselves

through the whole body. In that respect they are

comparable with a haze of desert sand - only if you

would sweep the grains together, you would see them.

At pathological research at women there have been

silicon found in each tissue and each organ of the

body. Sometimes silicon leave the body by means of the

skin. There are also women who have found sannd-grains

in their urine. But generally they continue to stay in

the body. The molecules are too large to be removed by

the kidney-membrane.

The silicon disease (Silicon Related Disease - SRD) is

a disorder which damages your immume system. Women who

suffer from disease show among others the following

complaints - changing muscle - and articular-pain

(like rheumatism), demolishing fatigue (like ME),

memory impairments, back complaints, neurological

complaints, thyroid- and pancreas-disorders,

thickening of the skin and allergies. Doctors are in

the blue about the causes of this complaints, but they

are almost never to be traced, tracked and thus not

treatable. The only thing doctors are sure about is

that the complaints are NOT caused by silicon.

Siliconen would be safe, because they are inertia.

This means - not active. Chemically this indeed is

correct, but biologically silicon are active. It has

been proved scientifically that silicon biologically

are not inert and therefore produce impairments in the

body. Moreover there are, due to the chemical procede

process of silicate to silicon, 39 chemicals (among

other things toluene, acetone, formaldehyde, benzene,

dichloormetaan - dutch: tolueen, aceton, formaldehyde,

benzeen, dichloormetaan) and 8 heavy metal (among

other things barium, silver, nickel, chromium - dutch:

barium, zilver, nikkel, chroom) hidden in the

implants.

What exactly is the wrongdoer, the chemicals or the

silicon, is at that moment not yet clear. But the

substances always come in combination with each other

in your body. And how does your body react then? I

myself think that every woman with implantssooner or

later will have problems from it. But if woman only

get complaints on older, later age (the incubation

time can be 20 years) the complaints are slid onto the

age. Complaints of younger women according to the

doctors mostly are between the ears. On average 3000

implants per year are put in. 26% get within 5 yeras

such complaints that another operation is neccessary,

particularly the local complications as encase,

deforms and movement. After 6-8 years most of the

women get changing sometimes still vague health

complaints. Of all women ever operated in the

Netherlands 10% have meanwhile already communicated

themselves at the SVS as a silicon victim. At some

women immediately an extreme improvement in health

steps up after removal of the implants. The largest

group needs 2 up to 5 years for slightly recovery. For

a small group unfortunately the 'point or no return '

has been reached and these women die a mysterious

death, which is dismissed with declarations such as

" the age " or other never determined sicknesses.

Women who get implants always are fortunate with them.

They do not think of the possible consequences or do

not want to think about it. As long as the doctors are

not yet punished, they continue to deny that those

small pockets will eventualy leak in the long run and

as a result problems can arise. It is than not strange

that a woman does not realise inwhich she starts ?

Even the so-called safe salt-water prosthesis are

risky business. At first, these water-pockets are

packaged in an envelope

of..........yes,right.....silicon. Moreover that

stationary water gets, on a nice temperature in

combination with the functioning of your body, very

easy infected with bacteria. The silicon-envelope thus

always breaths on ! The bacteria are even possible

during filling or during the implanting in the

operation room ER of coming into the water. The

consequence can be guessed - moulds and fungus in your

small pocket ! And leakage of these pockets can have

deadly impact. Although the complete medical science

are aware, informed of all these matters and the use

of silicon in America has even been forbidden since

1992, the lords doktors cover themselves in silence.

There is a surgeon who has said rockly-hard: " If

breast enlarge operations would be forbidden at five

o'clock this afternoon, then I will put in my last

implant at five to five " . And that is now exactly the

reason why almost every plastic surgeon keeps its

mouth shut. Putting implants in means gold money.

RISKS OF BREAST-IMPLANTS

(1) the implants can tear, break, by mammography

(2) breast implants make own self-research

mammography. Several x-rays are necessary, as a result

of which more radiation comes in the body every time

(3) torn or leaking implants remain many years'

unnoticed, whereas of siliconen it is known that it

penetrates the lymfatisch system and has been found at

implanted women in the brain, back marrow, uterus,

liver and other organs

(4) implants will not live a life long. they must be

replaced within 10 years (even without health

problems)

(5) there are ALWAYS infecties possibly including

moulds and antibiotic resistent bacteria

(6) feeling loss of the breast, especially around the

nipples and the nipple court have been mentioned, just

like over sensesitivity at contact

(7) astringency (becoming hard of the breast) can be a

very unpleasant sense, from very painfull tot

misforming

(8) Many woman have different rejection-complaints and

other forms of breast-tissue loss

(9) many women have developed serious defence system

sicknesses as rheamatism, M.S., Lupus, etc. sometimes

already shortly after the implantation. Women with a

weak defence system have been now been warned and can

better avoid implants

(10) large numbers of of women with implants have

reported neurological and well-known complications,

but also hormonal troubles, including uterus-removals,

miscarriages

(11) many children, born after implantation, appeared

to have the same defence system complaints, something

which has not yet been studied enough.

(12) breast implants mostly have a negative effect on

the milk production at giving breastfeed. Breast

feeding is better not to with implants.

(13) Health insurance companies refuse to pay for the

routine costs for the woman who have implants and

those who had them removed.

----------------------------------------------------------------

Silicone Implant Disease

By Ron Kennedy, M.D., Santa , California - 2000

........ Now, 38 years later, it is clear that silicon

enhancement of breasts can be hazardous to the health

of the recipient. The real cost of cosmetic breast

enhancement may not be the $10,000 in surgical fees to

implant them, but a host of autoimmune symptoms and

strange illnesses that can crop up, typically within

about seven years of implantation......

http://www.medical-library.net/sites/framer.html?/sites/_silicone_implant_diseas\

e.html

Platinum & Silicone Breast Implants - Letter

FROM - The FDA Deputy Director for Regulations and

Policy

TO - Keeling, President Chemically Associated

Neurological Disorders

Dear Ms. Keeling,

This letter is in response to your petition (Docket

Number OOP-1607/CP- 1) received by FDA on November

3,200O and filed on November 7,200O. Your petition

requested that FDA revoke the implantation of silicone

gel-filled breast implants for any reason, and that

remaining inventories of these devices in the United

States be destroyed.........

http://www.fda.gov/ohrms/dockets/dailys/03/Nov03/111903/03p-0530-cp00001-Exhibit\

-Tab-O-vol1.pdf

http://66.249.93.104/search?q=cache:q6Uz_JwqTuAJ:www.fda.gov/ohrms/dockets/daily\

s/03/Nov03/111903/03p-0530-cp00001-Exhibit-Tab-O-vol1.pdf+Platinum+may+leak+from\

+breast+implants & hl=nl & ie=UTF-8

! Breast Implants

People, Politics, Polymers

Buddy Ratner ** ratner@... ?-

University of Washington

- Disclosure Statement - " I have been an expert

witness for 3M, Dow-Corning Corporation and for Baxter

Healthcare. I have accepted research funds from Dow

Corning, Mentor Corp. and from McGhan Corporation "

----------

NOTE - **

Health Scientists tackle implant rejection

BBC, UK - April 15, 1999

..Professor Buddy Ratner, who leads the project, said:

" The ability to make surfaces that can be recognised

by the body is a major step forward in our quest for

biomaterials and implants that heal. " This is the

first coating process that works on the atomically

flat surfaces of artificial materials commonly used in

implants and that promotes affinity for specific

proteins. Our approach potentially can be used for any

kind of implant. " ..

http://news.bbc.co.uk/1/hi/health/319873.stm

----------

" The recent attention given to breast implants and

their relative safety is a sham perpetrated by the

billion dollar companies that manufacture these lethal

bags and the plastic surgeons that put them in. If the

truth about these implants were to be known it would

be revealed to be the greatest crime against women in

the 20th century. The reports are RIGHT ! They can't

prove a link to any known diseases because the disease

that these women are getting is a NEW disease with

symptoms similar to many known diseases. But actually

it's a reaction to toxic chemicals that spread

throughout the body. Silicone being only one of them "

http://acad.bioeng.washington.edu/590/BuddyLecture.pdf

LINKS in, from this article -

(1) - Known Risks of Breast Implants

http://www.fda.gov/fdac/features/995_implants.html#known

(2) - Breast Implant Classification with MR Imaging

Correlation

http://ej.rsna.org/ej3/0112-99.fin/body/onepage.htm#Cat1

(3) - Information for Women about the Safety of

Silicone Breast Implants (2000)

http://books.nap.edu/books/0309065933/html/20.html#pagetop

(4) - References on capsular contracture , References

on implant rupture/leakage

(Site information is the Exclusive Property of Dow

Corning Corporation)

http://www.implantclaims.com/ebooklet98/Section_F.asp#F03

=>

United States District Court-Eastern District of

Michigan

http://www.mied.uscourts.gov/_dow/dowdefault.htm

Claimants' Advisory Committee

http://www.tortcomm.org/plandocs.shtml

Settlement Facility for Dow Corning Trust

http://www.sfdct.com/downloads.cfm

Compensation for breast implant women

BBC, UK - 24 November, 2000

Women who had their breast implants removed after

serious health warnings are to receive compensation.

Around 5,000 women in the UK have had the soya-oil

filled Trilucent implants fitted.

The implants were removed from sale in March, and in

June the government warned women to have them

removed.......

http://news.bbc.co.uk/1/hi/health/1039225.stm

Breast Implants: America's Silent Epidemic

Total Health for Longevity Magazine

November/December 2000, Volume 22, Number 6 pages

41-42

By Ilena Rosenthal ilena2000@...

http://www.mercola.com/2001/jun/6/breast_implants.htm

Breast implants withdrawn

BBC, UK - 11 December, 2000

A type of breast implant has been withdrawn from the

UK market amid fears that it could be unsafe.

The Department of Health acted after an investigation

by the Medical Devices Agency found " inadequacies " in

the safety assessments of the manufacturers of the

hydrogel-filled implants.

http://news.bbc.co.uk/1/hi/health/1065415.stm

Breast-implant debate may shift focus to effects of

platinum leakage

Star Tribune, Greg Gordon ggordon@... ,

ggordon@...

December 18, 2000

WASHINGTON, D.C. -- A National Academy of Sciences

panel last year found no basis for concerns that

silicone-gelbreastimplants cause health damage, but

debate on their safety persists with a new focus.

Several researchers are trying to persuade the U.S.

Food and Drug Administration (FDA) that implant safety

reviews have focused too much on the effects of

silicone and too little on whether toxic platinum

leaked into women's bodies from some of the devices...

http://list.mc.duke.edu/cgi-bin/wa?A2=ind0012 & L=oem-announce & T=0 & O=A & P=10285

Government hasn't pursued suggestions

to test silicone breast implants

Star Tribune, Greg Gordon ggordon@... ,

ggordon@...

December 23, 2000

WASHINGTON, D.C. -- A government scientist proposed a

study four years ago to explore whether silicone gel

breast implants could have leaked toxic forms of

platinum into women's bodies, as some health

professionals feared. But the proposal by

Biagini, a research toxicologist at the National

Institute for Occupational Safety and Health who is a

leading platinum expert, went nowhere. Now, the Food

and Drug Administration (FDA) says it needs more data

to determine whether platinum may be a culprit in the

illnesses of some of the half-million women who have

sued implant manufacturers.....

http://list.mc.duke.edu/cgi-bin/wa?A2=ind0012 & L=oem-announce & T=0 & O=A & P=10285

2001

Surgeon rules out teenager's breast op

BBC, UK - 4 January, 2001

A surgeon has said he will not carry out a breast

enlargement promised by a mother to her daughter as a

16th birthday present...

http://news.bbc.co.uk/1/hi/health/1101015.stm

Prize is breast implant surgery

Daily Telegraph - 7 february 2001

A mother won a breast implant operation yesterday in a

competition on a breakfast radio show. Kerry Froggett,

26, of Newton Heath, Manchester, will receive £2,500

for the surgery. Ms Froggett is a care worker with two

children called Ocean, four, and Sunny, two. Her

mother had written to the Manchester-based Key 103

radio station's JK & Breakfast Show, nominating

her daughter for the cash prize. She said that her

daughter had lost her figure after child-bearing and

was depressed.

(SOURCE-

http://www.telegraph.co.uk/news/main.jhtml?xml=/news/2001/02/07/nbul07.xml)

Breast implant cancer link

BBC, UK - 27 April, 2001

Women who have breast implants appear to suffer more

lung and brain cancers than other plastic surgery

patients, a study says.The preliminary results of the

US National Cancer Institute (NCI) tests were reported

in the New York Times..

http://news.bbc.co.uk/1/hi/health/1299959.stm

EU considers breast implant measures

BBC, UK, 21 March, 2001

Measures to improve the safety of silicone breast

implants are being considered by the European

Commission. Proposals, presented to MEPs on Wednesday

by EU Enterprise Commissioner Erkki Liikanen

erkki.liikanen@..., include:..

http://news.bbc.co.uk/1/hi/health/1232441.stm

Scots' Campaign leads to new EC-Rules on Implants

21 March 2001 , The Herald, UK

New safety measures governing the use of silicone

breast implants will be outlined by the European

Commission today, 10 years after a Scotswoman launched

a campaign against their use. Margo Cameron was left

with traces of silicone throughout her body after

having the toxic substance injected into her lips as a

pre-wedding present from her fiancé. Her plight was

taken up by Bill , the ish Labour Euro MP,

who has played a key role in persuading the commission

to start work on new safety recommendations. ( SOURCE

- http://www.bnn-online.co.uk/news )

UK Parliament: Health Warnings on Adverts Breast

Implants

Examination of Witness - Prof. Sturrock

RDSturrock@...

22 March 2001

http://www.publications.parliament.uk/pa/cm200001/cmselect/cmhealth/308/1032202.\

htm

Register of breast implants proposed

Daily Telegraph, By

nicole.martin@... - 22 march 2001

A register of every silicone breast implant operation

in Europe was among proposals put to the European

Commission yesterday to help to protect the thousands

of women who have the surgery each year....

http://www.telegraph.co.uk/news/main.jhtml?xml=/news/2001/03/22/nimp22.xml

Study gives firm support to breast implants

March 26 2001

Chicago - There is little evidence that silicone

breast implants trigger production of an antibody that

has been linked to cancer and other diseases,

according to a study published on Sunday. In a study

of 288 women who had had or still had breast implants,

researchers from Brigham and Women's Hospital and

Harvard Medical School found that five had an

excessive production of an antibody protein in blood

plasma cells that in some cases precedes development

of other diseases, such as multiple myeloma...

http://www.int.iol.co.za/index.php?set_id=1 & click_id=31 & art_id=qw985532581457B24\

3

European Parliament: Safety rules for breast implants

28 March 2001

The European Commission has told MEPs that it is to

consider new guidelines on the use of silicone breast

implants. These include a register of every silicone

breast implant operation carried out in Europe, a

register of qualified surgeons, better counselling,

and further research into the health risks of

implants. The Commission's move came in response to

two petitions received by the Parliament's Petitions

Committee which express concern about the dangers to

women's health of silicone breast implants. Both

petitions call for an immediate ban on silicone

implants although this has been ruled out by the

Commission in the immediate future. Most MEPs on the

Petitions Committee felt that strict regulation of

breast implants would be a better alternative than a

total ban. However, a ban was favoured by ish MEP

Bill bill.miller@... ,

bmiller@... , BMEP@..., who

presented one of the two petitions, after campaigning

for many years to raise awareness of the potential

dangers of silicone implants.

( SOURCE -

http://www.europarl.org.uk/news/items2001/march28.htm

)

Study gives firm support to breast implants

Study finds little sign breast implants unsafe

Shanghai Star, 29 march 2001

CHICAGO - There is little evidence that silicone

breast implants trigger production of an antibody that

has been linked to cancer and other diseases,

according to a study published recently.

In a study of 288 women who had or still had breast

implants, researchers from Brigham and Women's

Hospital and Harvard Medical School ..........

http://app1.chinadaily.com.cn/star/2001/0329/he15-3.html

http://www.int.iol.co.za/index.php?set_id=1 & click_id=31 & art_id=qw985532581457B24\

3

Health department misled women over breast implant

risks

Zosia Kmietowicz London - BMJ 31 march 2001 ;322:756

Campaigning groups concerned about the safety of

breast implants have strongly criticised the UK

Department of Health for the way it has handled the

issue........

http://bmj.bmjjournals.com/cgi/content/full/322/7289/756/d

UK Parliament - House of Commons

The Health Committee - healthcom@... ? - 4

April 2001

4th Report - Provision of Information by the

Government - Safety of Breast Implants

http://www.publications.parliament.uk/pa/cm200001/cmselect/cmhealth/308/30803.ht\

m

Health Warnings with Implants

5 April 2001 , The Herald, UK

Adverts for cosmetic surgery such as breast implants

should carry health warnings about the dangers

involved, an influential committee of MPs said

yesterday. And the proposal was immediately hailed as

a " great victory " by campaigners. The Commons health

select committee said that members of the public

should be made fully aware of the dangers involved in

this form of breast augmentation, and said that women

considering having the procedure should have access to

independent advice and counselling. ( SOURCE -

http://www.bnn-online.co.uk/news )

Breast Implant Cancer Worry

27 April 2001 . The Mirror, UK

Women with breast implants are three times more likely

to get cancer than those without, a study revealed

yesterday. And scientists say saline replacements, not

just the controversial silicone ones, are also being

linked to tumours. The US study of 13,500 women found

they were at risk form brain and lung cancer.

Researcher Dr Zuckerman, said: " This is

alarming. I see it as a warning. " The report comes

after a Commons select committee recommended there

should be a new system to monitor side-effects of

breast implants in British women.

( SOURCE - http://www.bnn-online.co.uk/news )

Breast implants linked to brain and lung cancer

Boseley sarah.boseley@..., health

editor

The Guardian - April 27, 2001

Women with breast implants of any variety are

statistically up to three times more likely to die

from lung or brain cancer than those without, a

12-year study has shown.....

http://www.guardian.co.uk/uk_news/story/0,3604,479214,00.html

Breast implant payouts

Daily Telegraph, Barbie Dutter, Sydney - 23 may 2001

More than 3,000 Australian women who suffered severe

health disorders from ruptured silicone gel breast

implants are each to receive up to £22,000

compensation. About 200,000 women worldwide have

suffered as a result of the implants. Disorders

include lupus and rheumatoid arthritis. Most of those

affected are still fighting for compensation from the

implant manufacturer Dow Corning, which filed for

bankruptcy in 1995.The Australian settlement is the

only deal the company has agreed to date(SOURCE-

http://www.telegraph.co.uk/news/main.jhtml?xml=/news/2001/05/23/wbul23.xml)

European Parliament: " Stop using Silicone Implants "

Brussels, 13 june 2001

Report (A5-0186/2001) by Mrs Fourtou

Presse-fr@... , jfourtou@...,

on behalf of the Committee on Petitions, on petitions

declared admissible concerning Silicone Breast

Implants (Petitions 0470/1998 and 0771/1998)

(2001/2068(INI))

Meijer (GUE/NGL) emeijer@... ,

emeijer@..., (NL) - " ......In the

circumstances, it is better to stop using the silicone

implants and to focus on developing alternatives.

France has now banned the implants, but other Member

States are wavering and indecisive. I agree with those

who submitted the petitions that silicone breast

implants should not be used until they have been

proved not to be harmful......... "

Sacrédeus (PPE-DE), (SV) press-sv@... ,

lennart.sacredeus@... - " I have voted

against the proposal. The report before us concerns

silicon implants, with proposals for rules,

regulations, an age limit of 18 for breast implants

for cosmetic reasons and the establishment of a

European patient register "

http://europa.eu.int/constitution/futurum/documents/speech/sp130601_2_en.pdf

Beauty and the Breast:

The implant controversy continues

25 June 2001

The investigation found that Mentor, one of the two

biggest companies in implant business may have

knowingly allowed faulty breast implants onto the

market, forcing women in both countries to go under

needless surgeries. Canadian women were applying for

long-term disability because the implants had made

them too sick to work. Women from four

provinces-Ontario, Saskatchewan, Quebec and British

Columbia had filed class-action suits against Health

Canada.

Number - 18565, Subject - Health, Source - Canadian

Broadcasting Corp. - CBC Radio News, Title - Beauty

and the breast: the implant controversy continues,

Author(s) - McKie; Bartlett , Category -

Computer-Assisted Reporting, Contest Entry , Total

pages - 38, Keywords- AUDIO TAPE; TRANSCRIPT; fraud;

criminal investigation; saline implants; law; safety;

CAR..

http://www.cbc.ca/consumers/indepth/breast_implants/index.html

Breast Implant Litigation MDL926

September 25, 2001

Important new information for those wishing to contact

the Settlement Facility-Dow Corning Trust

http://www.fjc.gov/BREIMLIT/mdl926.htm

Summary of Report of National Science Panel

Silicone Breast Implants in Relation to Connective

Tissue Diseases and Immunologic Dysfunction

http://www.fjc.gov/BREIMLIT/SCIENCE/summary.htm

Is the FDA Safe and Effective?

By Dr. B. Klein dklein@..., Associate

Professor of Economics, Santa Clara University, and

Dr. Tabarrok ATabarrok@..., Vice

President and Director of Research the Independent

Institute - Drs. Klein and Tabarrok have independently

published research on numerous public policy topics -

September 26, 2001

Medical drugs and devices cannot be marketed in the

United States unless the Food and

Drug Administration (FDA) grants specific approval. We

argue that FDA control over drugs and

devices has large and often overlooked costs that

almost certainly exceed the benefits. We

believe that FDA regulation of the medical industry

has suppressed and delayed new drugs and

devices, and has increased costs, with a net result of

more morbidity and mortality. A large body

of academic research has investigated the FDA and with

unusual consensus has reached the same

conclusion. Drawing on this body of research, we

evaluate the costs and benefits of FDA policy. We

also present a detailed history of the FDA, a review

of the major plans for FDA reform, a

glossary of terms, a collection of quotes from

economists who have studied the FDA, and a

bibliography with many webbed links. A more detailed

table of contents follows. We are happy

to receive comments and criticisms.....

http://www.fdareview.org/fda.pdf

Raising Health Awareness Through Examining Benign

Brain Tumor Cancer, Alpha One and Breast Implant

Issues.

Subcommittee on Health

November 15, 2001

Prepared Witness Testimony - Miss. Pamela

Noonan-Saraceni

.....Mr. Chairman and Members of this Committee: My

name is Pam Noonan-Saraceni. As a breast cancer

survivor who continues to endure the painful physical

side-effects of silicone breast implants, I am pleased

to have the opportunity to take part in this

hearing.....

http://energycommerce.house.gov/107/hearings/11152001Hearing428/Noonan-Saraceni7\

30print.htm

Silicone Gel Breast Implant Rupture, Extracapsular

Silicone,

and Health Status in a Population of Women

S. L. Brown, G. Pennello, W.A. Berg, M. Scoo,

M.S. Middleton

J Rheumatol 2001; 28:996-1003

ABSTRACT.

Objective - To assess whether breast implant rupture

or extracapsular silicone are associated with selected

symptoms of self-reported physician-diagnosed

connective tissue disease (CTD).

Conclusion - These data suggest an association between

extracapsular silicone from ruptured silicone breast

implants and FM. If this association persists in other

studies, women with silicone gel breast implants

should be informed of the potential risk of developing

fibromyalgia if their breast implants rupture and the

silicone gel escapes the fibrous scar capsule

http://list.mc.duke.edu/cgi-bin/wa?A2=ind0105 & L=occ-env-med-l & D=0 & P=9669

http://www.FDA.gov/cdrh/breastimplants/extracapstudy.pdf

Immoral Science and my Nuclear Odyssey

The World Behind the Security Fence

- An Appeal to all Scientists Worldwide - by s

Toupadakis, Ph.D., a Former Research - Scientist of

Los Alamos and Lawrence Livermore National

Laboratories.

- Media Monitors Network, Dec 31, 2001

On January 31 of this year, I resigned from a

permanent, highly paid, classified position in the

Stockpile Stewardship Program at the Lawrence

Livermore National Laboratory (LLNL) in California. I

went to LLNL believing that I would be useful in

helping to dismantle nuclear weapons and in disposing

of their deadly byproducts. That was my desire.

Instead, very soon, I found myself expected to work on

the maintenance of nuclear weapons. When I realized

that within the Lab, environmental or nonproliferation

work was but an illusion, I decided to resign. My

conscience simply does not allow me to work for the

development or maintenance of nuclear weapons. I

believe that if a foundation or institution is corrupt

you must wash your hands and withdraw from it. Today I

would like to tell you my

story.................(...)..........I accepted an

offer from Dow Corning in the spring of 1991 and left

LANL. During my two years with Dow Corning I lived in

the place of proprietary information and secrecy for

profit. The breast implant issue was on the news

almost daily and the word about bankruptcy and likely

layoffs was going around, and in fact they did file

for bankruptcy later after I left. I realized that

everything there was done for profit and not for the

wellbeing of humans. The vision of the company was to

put a deodorant in the hand of every African and Asian

citizen. I was shocked to recognize their plans while

at the same time they talked about integrity. By then,

I was really disappointed about being a chemist. I was

providing my skills to immoral science, helping the

company make profits at the expense of the uneducated

public. .....

http://linkage.rockefeller.edu/wli/reading/toupadakis1.html

2002

World Health Organization:

Science and Society Public dialogue in scientific

research

27 may 2002 ?

19 From community action to policy impact: The case of

silicone breast implants ...

To consider silicone breast implants a research

priority and make funds..........

To facilitate consensus on a breast implant consent

form including. information

related to alternatives, .................

To guarantee marketing control over breast implants in

order to avoid any ..........

http://www.euro.who.int/observatory/Publications/20020527_15

European Parliament: Improving safety of breast

implants

Enterprise Europe, no 7, april-june 2002

Contact - Lacerda de Queiroz -

.Lacerda@...

A growing number of women in Europe receive breast

implants, either for reconstructive surgery or for

cosmetic reasons. Improving breast implant safety

entails both tightening up safety requirements for

products, and stepping up the quality and quantity of

information for doctors and patients.....

http://europa.eu.int/comm/enterprise/library/enterprise-europe/issue7/articles/e\

n/enterprise11_en.htm

European Commission & Breast Implants

Brussels, 13 June, 2002

Standardization mandate - Development of European

standards relating to medical devices

http://europa.eu.int/comm/enterprise/medical_devices/breast_implant/m320en.pdf

Science and the Statistical Victim:

Modernizing Knowledge in Breast Implant Litigation

SAGE, Social Studies of Science, Vol. 32, No. 1, 37-69

(2002)

Sheila Jasanoff sheila_jasanoff@...

Using silicone gel breast implant litigation as a case

study, this paper argues that the attempt to marry

judicial concerns for individual justice with

administrative concerns for speed, efficiency and

economy has produced anomalous results. The testimony

of the clinician and the victim has become less

relevant as judicial remedies take account of injuries

done to classes of plaintiffs. Subjective claims about

the body are subordinated to statistical correlations

between exposure and grouped complaints. At the same

time, the transfer of fact-finding authority from

juries to judges under new evidentiary rules has

privileged the judiciary's lay knowledge and

experience over that of the jury. While these

transformations may hasten the processing of cases,

the paper questions whether the courts can

legitimately take on board the issues of risk and

social justice in contemporary industrial

societies......

http://sss.sagepub.com/cgi/content/abstract/32/1/37

http://sss.sagepub.com/cgi/reprint/32/1/37 [PDF]

Greenwood Want Details From FDA on Breast Implant

Studies

Correspondence - The House Committee on Energy and

Commerce - July 11, 2002

LETTER FROM - W.J. " " Tauzin

TO - Lester M. Crawford, D.V.M., Ph.D. Deputy

Commissioner FDA

Dear Dr. Crawford,

On July 9, 2002, two saline breast implant

manufacturers, Mentor Corporation and Inamed,

presented studies at an FDA advisory committee hearing

that showed more than a quarter of women who receive

saline implants to increase the size of their breasts

will undergo another breast operation within five

years........

http://energycommerce.house.gov/107/Letters/07112002_651.htm

http://energycommerce.house.gov/107/News/09272002_739.htm

Breast Implant Settlement

The Associated Press - 1 september 2002

U.S. pharmaceutical maker Bristol-Myers Squibb Co. has

reached an out of court settlement with a group of

Australian women over faulty breast implants

manufactured by the company, a court heard

Tuesday.......

http://www.fonendo.com/noticias/20/2002/09/1.shtml

Women victors over faulty implant maker

The Sydney Morning Herald - September 11 2002

By Robotham jrobotham@... and Fergus

Shiel

Thousands of Australian women have received individual

payments of up to $120,000 after suing the Dow Corning

Corporation over faulty silicone breast

implants.......

http://www.smh.com.au/articles/2002/09/10/1031608246351.html

Woman attacks breast implant payout

The Sydney Morning Herald - September 25 2002

A New Zealand woman has attacked the size of the

payout she received from a United States company for

the suffering caused by their silicon gel breast

implants. Kathy , from Timaru, is one of about

six New Zealand women who received the Dow Corning

silicone breast implants in Australia....

http://www.smh.com.au/articles/2002/09/25/1032734172554.html

2003

Breast implants - Debates of the European Parliament

13 february 2003

http://www.europarl.eu.int/debatsL5/debatsL5?FILE=20030213EN & LANGUE=EN & LEVEL=TOC\

2 & CHAP=3

http://www.europarl.eu.int/debatsL5/debatsL5?FILE=20030213EN & LEVEL=DOC & NUMINT=4-\

043 & LANGUE=EN

http://www.europarl.eu.int/debatsL5/debatsL5?FILE=20030213EN & LEVEL=DOC & NUMINT=4-\

044 & LANGUE=EN#top

http://www.europarl.eu.int/omk/omnsapir.so/debatsL5?FILE=20030213EN & LANGUE=EN & LE\

VEL=DOC & NUMINT=4-045 & textMode=on

Implants Ban on Under- 18s

19 February 2003, London Evening Standard

Girls under 18 could be banned from having breast

implant surgery following a vote by Euro MPs. Tough

new regulations on cosmetic surgery have been backed

by the European Parliament and could come into force

by the end of next year. They would ban women under 18

from undergoing cosmetic surgery such as breast

enhancement, amid concerns that teenagers are having

the operations while still going through puberty. The

European Commission must now draw up a directive

setting out all the regulations, which the 15 member

states will then vote on. The decision is a victory

for Margo Cameron, a ish woman who has lobbied

for more regulation, claiming she suffered years of

agony after silicon injections in her lips. Under the

proposed law, clinics will be be banned from

advertising breast operations with " before and after "

photographs, and will have to provide pre and

postsurgery counselling. They will also have to keep a

log of all operations they carry out.

( SOURCE - http://www.bnn-online.co.uk/news )

Breast implants: EU developments

The European Commission proposed tighter controls on

breast implant safety, and an upgrade of the relevant

European standards, as part of a joint drive with

Member States to improve implant quality, information

provision, and post-surgical

follow-up....................

LINKS in this article -

- European Parliament Update Report (Study) on Health

risks posed by silicone implants ingeneral, with a

special attention to breast implants (30 May 2003)

- EC Directive 2003/12/EC on the reclassification of

breast implants in the framework of Directive 93/42/EC

concerning medical devices (3 February 2003)

- EC Press Release: Breast implants: Commission

proposes better monitoring and information

(15th November 2001)

- EC Communication: Community and National measures in

relation to Breast Implants

(15th November 2001)

- European Parliament final report on the petitions

declared admissible concerning silicone implants

(28th May 2001)

- European Parliament Final Study on Health Risks

posed by Silicone Implants in general with special

attention to Breast Implants (June 2000)- Working

document for the STOA Panel

- BBC News: " Victory for breast implant victims " 15

November, 2001

http://www.eucomed.be/?x=4 & y=2 & z=149 & id=307

EU parliament calls for tougher rules on breast

implants

British Medical Journal, BMJ 2003;326:414

Brussels, The Herald, Rory

rorywatson@...

22 February 2003

The European parliament has given its backing to

tougher health and safety rules across the European

Union on breast implants. The move follows a 10 year

campaign from women whose health has deteriorated

after ruptured silicone gel implants....(...)....His

ish Labour colleague Stihler *, who

steered the report through the parliament, said: " We

have legal limits for alcohol to protect the young. An

18 year limit for implants will safeguard teenagers in

school uniforms from an ill informed beauty choice. "

......

http://bmj.bmjjournals.com/cgi/content/full/326/7386/414/e

* Stihler - cstihler@... ,

cstihler@...

- Labour Member of the European Parliament (MEP) for

Scotland

- Rapporteur on Silicone gel Breast Implants (2002)

http://www.cstihlermep.com/

Alarm over Rise in Silicone Iplants

7 March 2003, The Herald, UK

Health campaigners yesterday warned of an " alarming

rise " in the number of women in Scotland risking their

health by having silicone breast implants. They said

the lifting of a 10-year ban on the use of the

controversial gel in America had prompted thousands

more women in Britain to opt for silicone-based

cosmetic surgery. They predict the impact would be

felt most in Scotland which has the highest rate of

breast enhancement in the UK. Bill , the Scots

Euro MP who has led a seven-year campaign for silicone

breast implants to be outlawed, said the decision by

the US food and drug administration to end the ban

would have a " disastrous " knock-on effect in the UK,

particularly in Scotland. ( SOURCE -

http://www.bnn-online.co.uk/news )

Breast implants linked to suicide

By Womack sarah.womack@... , Social

Affairs Correspondent

7 march 2003

Women who opt for breast implants to enhance their

natural assets are more likely to commit suicide,

scientists say today. Researchers at the University

Medical Centre in Utrecht believe the surgery could be

linked to problems such as lack of self esteem. " Our

findings suggest there might be a psychological

problem in some women, " Dr Koot tells the

British Medical Journal....

http://www.telegraph.co.uk/news/main.jhtml?xml=/news/2003/03/07/wimpl07.xml

Breast Implants Linked to Higher Suicide Risk

By Reaney, patricia.reaney@... ?,

patricia.reaney@... ?

Reuters Health - March 2003

LONDON - Women who opt for breast implants to enhance

their natural assets are more likely to commit

suicide, Dutch and Swedish scientists said on

Thursday.......

http://preventdisease.com/news/articles/breast_implants_suicide_risk.shtml

One in seven breast implants rupture: study

July 16 2003

One in seven silicone breast implants will rupture as

early as three years after being put in, new research

has found. The findings are based on a two-year Danish

study of 271 women who had had breast implants for at

least three years....

http://www.smh.com.au/articles/2003/07/16/1058035061506.html

Many Breast Implants Rupture After 10 Years

Source- Archives of Surgery 2003.

NEW YORK Jul 24, 2003 (Reuters Health) - At least 15%

of silicone breast implants will rupture within 10

years after implantation, according to a report

published in the July issue of the Archives of

Surgery. .....

http://www.cancerpage.com/news/article.asp?id=6157

How to Bring Justice Back to the Court System

- A White Paper prepared - By and Myers

njmyers@... , Carolyn Raffensperger

75114.1164@... ?, raffenspergerc@... ? ,

executive director of the nonprofit Science and

Environmental Health Network http://www.sehn.org/, a

network that links scientists with environmental

groups and issues - July 2003

The breast-implant case is an example......Here is

what the panel actually said in its summary -

" The evaluation of immunologic responses to silicone

breast implants in humans faces significant

challenges. There are large numbers of diverse

immunologic responses that may be evoked in humans,

whether the subjects are healthy or ill, for which the

biological meaning and clinical interpretation is

uncertain. Furthermore, many of the studies available

for analysis are methodologically inadequate with

ill-defined or inappropriate comparison subjects,

unorthodox data analyses, and the potential for

systematic biases in laboratory methods. . . . Not

surprisingly, inconsistent results in studies

purporting to evaluate the same immunologic parameter

are common "

The court system has tied itself in knots by asking

the wrong kind of question in toxic torts. Professor

s phrases that question this way: " What

scientific evidence should a woman who believes she

has been injured by breast implants be permitted to

present in court? " According to s, the better

question would be, " What evidence of safety should

corporations be required to present in a public forum

before they are permitted to put their product on the

market? "

http://www.sehn.org/rtfdocs/white-paper.doc

Breast Implant get 'High-risk' Status

26 July 2003, The Independent, UK

Breast implants have been reclassified as " high-risk "

medical devices in an attempt to tighten regulation of

cosmetic surgery. The safety measures introduced by

the European Commission will see silicone implants

treated in the same risk category as replacement heart

valves and neurological implants. It means that

manufacturers must employ an independent assessment

body to examine all aspects of the design and

production process. A recent study in America found

that 69 per cent of silicone implants ruptured within

10 years. Under the measures, stringent safety checks

will be imposed on all implants used throughout

Europe. Lord Warner, a Health minister, said the new

rules would boost public confidence in breast implants

after a series of health scares

( SOURCE - http://www.bnn-online.co.uk/news )

Breast implant safety crackdown

BBC, UK - 1 September, 2003

Tough safety standards for breast implants, created in

response to fears over safety, come into force this

week. The rules were drawn up by the European

Commission in 2001 in response to a campaign by

British women. Many women have been forced to undergo

surgery to have implants removed after they say

silicone leakage from the implants ruined their

health.........

http://news.bbc.co.uk/2/hi/health/3198075.stm

Implant Imbroglio

While Medicare is suing breast implant manufacturers,

the FDA may be ready to finally embrace them. - TIME,

By Vveca Novak - Sep. 29, 2003

In a textbook case of clashing government policies,

two agencies of the Department of Health and Human

Services are approaching a controversial

issue—silicone breast implants—in very different ways.

.....

http://www.time.com/time/nation/article/0,8599,491252,00.html

Women with breast implants more likely to commit

suicide

The Washington Post, By Marc Kaufman

kaufmanm@...

October 4, 2003

A series of studies has found a surprisingly high

suicide rate among women who have had cosmetic breast

implants, sparking a new controversy about the

procedure just as the US Food and Drug Administration

(FDA) weighs whether to allow silicone gel implants

back on the American market.

http://www.smh.com.au/articles/2003/10/03/1064988410569.html

FDA General and Plastic Surgery Panel

October 14, 2003

Briefing Information - McGhan Silicone-Filled Breast

Inplants

http://www.fda.gov/ohrms/dockets/ac/03/briefing/3989b1.htm

http://www.fda.gov/ohrms/dockets/ac/03/briefing/3989b1_summary-panel-package.pdf

FDA / Silicone Breast Implants

TRANSCRIPT / CNN Live Today, October 14, 2003

DARYN KAGAN, CNN ANCHOR: Time for some health news

now. An FDA panel is holding a hearing today on

whether to lift a ban on silicone gel breast implants.

The panel is hearing from the manufacturer, who wants

the ban lifted, and from women on both sides of the

issue.

Our medical correspondent Cohen is here with

the details. What I was reading this morning? Over

200,000 women a year get breast implants. - ELIZABETH

COHEN, CNN MEDICAL CORRESPONDENT: Yes, it's a huge

number. Huge. I t's been a huge controversy. As you

said, 11 years ago they were banned by the Food and

Drug Administration. Now some people say they ought to

come back, and so the FDA is holding two days worth of

hearings, and this advisory committee that's holding

the hearings and at the end of the day tomorrow will

make a recommendation about whether or not they should

be allowed back on the market.....

http://edition.cnn.com/TRANSCRIPTS/0310/14/lt.05.html

TRANSCRIPT

Plastic Surgery devices Panel of Medical Devices

Advisory Committe

October 14, 2003

- Regulatory Overview of Silicone Gel-Filled Breast

Implants, Cilia M. Witten, Ph.D., M.D. 257

- Applicant Presentation Inamed Corporation, McGhan

Silicone-Filled Breast Implants

Conflict of Interest and Opening Remarks......

http://www.fda.gov/ohrms/dockets/ac/03/transcripts/3989T1.DOC

Pros, Cons Of Breast Implants

NEW YORK, Oct. 15, 2003

(CBS) The FDA is trying to decide whether to lift an

11-year ban on silicone breast implants, reigniting a

long-running debate on the safety of the implants as

they hear testimony from all sides. The Early Show

medical correspondent Senay explains that on

Wednesday, the FDA advisory panel is expected to vote

on whether to recommend that the decision be reversed.

.........

http://www.cbsnews.com/stories/2003/10/14/earlyshow/contributors/emilysenay/main\

578049.shtml

FDA says disease link not proven in implants

Wall Street Journal. 15 October 2003

The Food and Drug Administration said it can't

determine if severe illnesses can be blamed on Inamed

Corp.'s silicone implants because the company didn't

compare the products to saline implants or to symptoms

seen in women with no implants.........

http://www.aei-brookings.org/dailyregreport/archives/008777.php

Will Silicone Breast Implants Make A Come Back ?

President Bush Meets with APEC Leaders

CNN, October 18, 2003

ELIZABETH COHEN, CNN MEDICAL CORRESPONDENT: Welcome to

CNN's ON THE STORY, where our journalists have the

inside word on the stories we covered this week. I'm

Cohen in Atlanta, on the story of a step

closer to bringing silicone breast implants back on

the market. - MARIA RESSA, CNN MANILA BUREAU CHIEF:

I'm Ressa in Manila, on the story of President

Bush's just completed visit to the Philippines. His

message here, as it will be to the APEC leaders, is

that the war on terror continues. - JOSIE BURKE, CNN

CORRESPONDENT: I'm Josie Burke in New York, on the

story of a wild week in baseball that broke ratings

and hearts, but ultimately not curses...

http://transcripts.cnn.com/TRANSCRIPTS/0310/18/tt.00.html

Unsafe At Any Size

Silicon Breast Implants are Still Unsafe, Despite

Assertions in The New York Times

by Flanders laura@..., Host of

Working Assets Radio/San Francisco

October 23, 2003

An advisory panel to the Food and Drug Administration

(FDA) voted on Oct. 16 to recommend that silicone

breast implants be returned to the market after an

11-year ban. The verdict sent the share price of

Inamed, the manufacturer, soaring to a record high and

caused The New York Times to editorialize that " the

verdict adds to a growing impression that the

implants, once blamed for a range of serious illnesses

in women, are relatively safe. " ....

http://www.alternet.org/story/17023/

Silicone breast implants still available in UK

BMJ - Clare Dyer clare.dyer@...

Legal correspondent of the Guardian - 25 october

2003;327:947

Silicone gel breast implants have never been banned in

the United Kingdom as they have in the United States.

A series of UK government reviews, the last in 1998,

cleared them of causing ill health...

http://bmj.bmjjournals.com/cgi/content/full/327/7421/947-a

On child abuse and breast implants, our editorials are

vindicated.

The Power of Modern Fads

BY L. Bartley - October 27, 2003

A couple of disparate events sent ripples of

satisfaction through our editorial-page offices last

week. A Massachusetts parole board at long last

recommended Gerald Amirault for parole, and a Food and

Drug Administration panel recommended that silicone

breast implants be returned to the market.

http://opinionjournal.com/columnists/rbartley/?id=110004222

Researchers Call On Federal Government

to Create Breast Implant Registry

Canadian Women's Health Network http://www.cwhn.ca -

October 29, 2003

Health Complications from Breast Implant Surgery

Common. New Canadian study shows follow up procedures

from private breast implant surgery draws on public

health system.......

http://www.cwhn.ca/pr/10-29-03.html

A Painful Breast Implant from Infections in Medicine

Infect Med 20(4):172, 175, 193, 2003.

Discussion - M smegmatis was the second Mycobacterium

ever identified, the first being Mycobacterium

tuberculosis. Its initial isolation by Lustgarten in

18841 was from a secondarily infected syphilitic

lesion....

http://www.medscape.com/viewarticle/452421_3

FDA Advisor: " Ignore breast implant vote "

AHRP, 5 Nov 2003

Dr. Whalen, Chairman of FDA's advisory

committee that had voted on Nov 3 to approve with

restrictions the resumption of silicone breast

implants, wrote a letter to FDA Commissioner, Marc

McLellan, urging him to ignore the committee's vote

and not approve......

http://www.ahrp.org/infomail/03/11/05a.php

All Emotions Aside,

Silicone Breast Implants Still Pose A Serious Risk

By Congressman Gene Green (29th District of Texas) -

November 5, 2003

http://www.house.gov/green/contact/

Washington, DC - Proponents of approving silicone

breast implants sometimes accurately point out that

emotion played a role in the FDA's decision in 1992 to

withdraw silicone breast implants from the market.

After all, the documented pain and suffering endured

by thousands of women with ruptured, leaking implants

can make for quite an emotional issue.....

http://www.house.gov/apps/list/hearing/tx29_green/nc110503.htm

Say No to Silicone

By Mokhiber russell@...

White House reporter and editor of the Washington,

D.C.-based Corporate Crime Reporter

Dissident Voice - November 8, 2003

Eleven years ago, the U.S. Food and Drug

Administration announced it was pulling silicone

breast implants from the market, leaving them

available only to breast cancer survivors who needed

them for reconstruction or to women enrolled in

limited clinical studies......

http://www.dissidentvoice.org/Articles9/Mokhiber-Weissman_Implant-Danger.htm

Breast Implants and Breast Cancer Screening

MEDSCAPE, M. Smalley, CNM, MSN, 14 november 2003

http://www.medscape.com/viewarticle/462442?mpid=21519

Do Gels Really " Move and Feel " Like Breast Tissue?

Medscape General Medicine 5(3), 2003.

http://www.medscape.com/viewarticle/460148_3

Letter to FDA: Potential conflict of interest

Silicone Implant Advisory Panel Committee member Dr.

M. and his institution M.D. and Inamed

Aesthetics - November 17, 2003

Dear Dr. McClellan,

As you know, on October 14 and 15 the General and

Plastic Surgery Advisory Panel met to consider the

approval of Inamed's silicone gel-filled breast

implants......

http://www.citizen.org/publications/release.cfm?ID=7291

Breast Implants May Contribute to

Increased Use of Public Health Services

MEDSCAPE, Dec. 5, 2003, Mindy Hung mhung@...

Women with breast implants are hospitalized and visit

physicians more frequently than women who have not

undergone implantation surgery, according to a

retrospective cohort study funded by the British

Columbia Centre of Excellence for Women's Health in

Vancouver, Canada....

http://www.medscape.com/viewarticle/465509

Clever lawyers use " junk science " to dupe juries

into believing far-fetched claims

- AMessagefromtheDirector - R. Copland,

Director, Center for Legal Policy, Manhattan -

Institute for Policy Research -

www.TrialLawyersInc.com

- Drugs and Medical Devices - pg. 6

2003 report

.......For example, in 1995, 400,000 women registered

for a $4.25 billion fund established to compensate

them for injuries allegedly caused by silicone breast

implants—notably,an increased risk of breast cancer

and connective tissue diseases—despite any scientific

evidence that such implants were harmful. The

settlement followed two 1992 studies " showing that

breast implants were associated with a reduced rate of

breast cancer " and just preceded a major 1994

epidemiological study published in the New England

Journal of Medicine that found " no association between

implants and the connective tissue diseases and other

disorders that were studied. " Why would Dow Corning

enter into bankruptcy and a multibillion-dollar

settlement, given such evidence and the total absence

of studies establishing the litigation industry's

allegations? After losing a $7.5 million lawsuit to a

woman claiming illness caused by breast

implants........

http://www.triallawyersinc.com/TLI-HealthCare.pdf

2004

Silicone Setback

CNN, By Sora Song - Jan. 19, 2004

Silicone breast implants sometimes break and leak,

requiring further surgery and triggering other

complications, so in 1992 the FDA banned their routine

use. Last October an FDA advisory panel voted to allow

more durable implants back on the market. Now the

agency, which almost always follows its panels'

advice, has delayed approval to implant maker Inamed

until it gets more data about any long-term health

risks. Silicone implants may yet make a comeback, but

don't hold your breath.

http://www.time.com/time/archive/preview/0,10987,1101040119-574905,00.html

Implants may interfere with mammograms

Merritt McKinney, Reuters Health - January 27, 2004

NEW YORK - Breast implants make it harder to detect

breast cancer using mammography, new study findings

suggest. But even though mammography is less accurate

in women with breast implants, this does not mean that

women with implants are at greater risk of being

diagnosed with more advanced cancer: tumors were of

similar size and stage in women with and without

implants...

http://www.oncolink.upenn.edu/resources/article.cfm?c=3 & s=8 & ss=23 & Year=2004 & Mont\

h=1 & id=10447

Death shows danger of silicone injections

Health & Medicine Week - 19 April 2004

The death of a transsexual who received injections of

industrial-grade silicone illustrates the dangers of

" pumping, " a thriving underground practice in motel

rooms or apartments among men living as women.....

http://www.newsrx.com/issue_article/Health-and-Medicine-Week/2004-04-19/04192004\

3334895W.html

Mentor receives European approval for new silicone gel

breast implant

Health & Medicine Week - 19 April 2004

Mentor Corp. (MNT), a supplier of medical products in

the United States and internationally, announced that

it had been notified the company's low height, Contour

Profile Moderate Plus Memory Gel breast implant had

received European Union class III CE Mark approval.

http://www.newsrx.com/issue_article/Health-and-Medicine-Week/2004-04-19/04192004\

3331195W.html

Silicone Sage: Bankruptcy Ends for Dow Corning

Firm ends dark chapter caused by breast implant woes

Chemical & Engineering News, Marc S. Reisch

m_reisch@... - June 1, 2004

Dow Corning ended nine years and 16 days in bankruptcy

reorganization today. Over the past few weeks,

negotiators resolved a last-minute dispute over

interest due on $800 million in commercial claims,

allowing the firm to emerge as planned from court

supervision. Almost two months ago, Judge Page

Hood of U.S. District Court for the Eastern District

of Michigan set the date to end Dow Corning's ordeal.

That decision came just two weeks after an attorney

representing 48 Nevada women dropped his appeal of the

firm's $3.2 billion settlement with silicone gel

breast implant recipients........

http://pubs.acs.org/cen/news/8222/8222dow.html

FDA warns of risks from breast implants

Abergavenny Dobson - BMJ, 5 june 2004;328:1338,

doi:10.1136/bmj

Women considering breast augmentation should be aware

of the risk of implants rupturing and other adverse

events during mammography..

http://bmj.bmjjournals.com/cgi/content/full/328/7452/1338-c

More Girls Getting Implants From the 'Rents

FOXNEWS, June 15, 2004

Forget the convertible. A boob job is the latest

must-have on your teen daughter's graduation list. The

number of 18-year-olds who underwent breast-implant

surgery nearly tripled last year — from 3,872 in 2002

to 11,326 in 2003, according to the American Society

for Aesthetic Plastic Surgery

http://www.foxnews.com/story/0,2933,122668,00.html

Unrevealed

Non-Disclosure of Conflicts of Interest

In 4 Leading Medical and Scientific Journals

A Project of the Center for Science in the Public

Interest

By Merrill Goozner - Director of the Integrity in

Science Project - July 12, 2004

EXECUTIVE SUMMARY - The exponential growth of

financial conflicts of interest in medical and other

academic research represents a serious challenge to

guardians of scientific integrity. Conflicts of

interest can bias research in numerous ways – from the

questions asked to the samples selected to the

interpretation of data. Many leading journals have

adopted policies requiring disclosure of conflicts of

interest as their preferred method for managing such

conflicts. Some journals, like the Lancet, bar

conflicted authors from writing reviews or editorials.

As the editors of the Journal of the American Medical

Association said in 2001, " Full disclosure . . .

serves to highlight the potential for bias, but cannot

and does not eliminate the conflicts. "

EXAMPLE - The Jan. 28, 2004, study, " Effect of Breast

Augmentation on the Accuracy of Mammography and Cancer

Characteristics, " discloses that one author serves as

a consultant to the manufacturer of breast implants.

But it does not disclose last-author Dr. Karla

Kerlikowske's patent issued in 2003 for a " Device and

method for determining proportions of body materials, "

which " could be useful as a marker to predict cancer

risk. " Again, while the patent is not directly related

to the study, if the patented technology for

automating the measurement of breast density in

mammograms finds use in mammography, its market

potential could be impacted by the results of this

study.......http://www.cspinet.org/new/pdf/unrevealed_final.pdf

Artificial sweetener

Did anyone ask the silicone breast implant victims

if they were using Aspartame ?

LETTER - 20 July 2004

FROM - Dr. Betty i,

Founder Mission Possible International

http://www.dorway.com , http://www.wnho.net

TO - Senator Durbin dick@...

Dear Senator Durbin,

..........This is not to say that there aren't problems

with silicone breast implants, especially if they

rupture. An informant who called said he had worked

with aspartame, formaldehyde, silicone and Kodak, and

the problem is that when these silicone breast

implants rupture and come in contact with the

formaldehyde from aspartame, you will get all kinds of

deformities. The President of DOW was concerned enough

to contact Dr. but what happened after getting

the facts we will probably never know. Did he contact

Monsanto? Who knows. But they paid off in class

action. Dr. wrote a small book on silicone

breast implants and aspartame

http://www.sunsentpress.com/breast_asp.html

http://www.wnho.net/senator_durbin_letter.htm

SEE ALSO -

About the remarkable overlap of reported systemic

complications attributed to breast implants and those

suffered by more than 1400 aspartame victims reported

in many publications on aspartame disease -

http://ww.sunsentpress.com - Suggestion: read the

small book by H. J. , M.D., FACP, FCCP on this

subject titled, " Breast Implants or Aspartame

(NutraSweet-TM) Disease? " , to orient to this perceived

gross medicolegal travesty

NOTE -

Viva New Mexico ! We, the People, won ! Aspartame

Finally Imperiled !

New Mexico October 5, 2005

http://www.wnho.net/viva_new_mexico.htm

Aspartame linked to increased cancer risk in rats.

Nature, 19 November 2005.

http://www.nature.com/news/2005/051114/full/051114-15.html

MP calls for ban on 'unsafe' sweetener

Felicity Lawrence, felicity.lawrence@...

Consumer Affairs correspondent

December 15, 2005 - The Guardian

http://www.guardian.co.uk/food/Story/0,,1667734,00.html

Next generation of breast implants creates buzz, worry

Seattle Times, By Sommerfeld

jsommerfeld@... - July 27, 2004

The quest for the perfect breast has come full circle.

Even as checks from Dow Corning slip into mailboxes

this month, finally settling thousands of silicone

lawsuits, plastic surgeons and patients are clamoring

for the latest breast-boosting technology — the

next-generation silicone implant........

http://seattletimes.nwsource.com/html/health/2001960617_implants20m.html

Prime time television Breast Implant commercials: ABC

CNN.com - Transcripts - August 5, 2004

SERWER: Yes. CAFFERTY: One other item here and then

we'll toddle along. Prime time television commercials

advertising breast implants coming to ABC this fall.

Some outfit called Mentor Corporation scheduled to

debut six prime time commercials during the program on

ABC called " Extreme Makeover. " The company says it

wants to create a quote classy elegant ad... SERWER:

Classy. CAFFERTY: ... targeting the working woman or

mother. There is no word yet whether there will be any

advisories about the potential complications that can

arise from breast augmentation surgery or for that

matter why its supposedly a good idea to get breast

implants in the first place.

( SOURCE -

http://edition.cnn.com/TRANSCRIPTS/0408/05/ltm.03.html

)

- Breast implants may increase platinum levels

- Fears over 'harmful' platinum in breast implants

- More Platinum Found in Women With Implants

AP / Globe Staff , By Diedtra ,

dhenderson@...

26 august 2004

WASHINGTON - Researchers have found high

concentrations of platinum in women who got silicone

breast implants and in the children they bore and

breast-fed afterward. The type of platinum found in

the women's blood and urine was different than the

traces of regular platinum not uncommon in people's

bodies. It was a highly reactive platinum, used to

help turn silicon oil into the honey-like gel that

lends a more natural feel to a breast

implant........................

http://www.pahealthsystems.com/archive304-2004-9-66407.html

http://www.cbsnews.com/stories/2004/08/26/health/main638682.shtml

http://www.tucsoncitizen.com/index.php?page=national & story_id=082604b3_breastimp\

lants

http://thescotsman.scotsman.com/index.cfm?id=1002302004

http://www.msnbc.msn.com/id/5831273

Dr. Lykissa and Platinum,

Chemically Associated Neurological Disorders

By Ilena Rose - Ilena@...

4 September 2004

Dr. Lykissa uses state of the art equipment called an

ICP-MS (which can detect platinum in parts per

billion) and an Ion Chromatograph (to determine

ionization). It is recognized by the scientific

community that " platinum salts " (aka chloroplatinic

acid) can cause systemic disease in humans as a result

of toxic and/or hypersensitivity reactions. These

toxic and hypersensitivity reactions can range from

asthma, rhinorrhea, tinnitus, conjunctivitis,

urticaria, fatigue syndrome secondary to impaired

oxygen exchange, neurotoxicity, sicca syndrome, and

macular rashes............

http://www.talkaboutsupport.com/group/alt.support.cancer.breast/messages/46343.h\

tml

-------------------------------------------------------------

[free translation]

Silicone Breasts Perilous

Dutch Tv-programme 'Knevel op Zaterdag'

Dutch broadcastingorganisation 'EO' -

publieksservice@... , info@...

23 oktober 2004

Prominent experts state that silicone breast implants

leak perilous platinum. Many women contend because of

this with health problems. The dutch

topicality-programme 'Knevel on Zaterdag', is

dedicated this whole week to the possible health risks

of silicone implants. Moreover it is shown in the

programme, among other things with hidden camera's,

that - with exceptions- many private clinics give

misleading information concerning the risks of these

implants. The Dutch association of plastic surgeons

shows himself shocked and will intervene.

Prof. Dr. Ernest Lykissa, toxicologist from Houston

has determined - in association with the university of

Washington - in new research that from silicone

implants the substance 'loaded platinum' leaks: " We

have found it in the liver, ovaries, nerves, leg

marrow and the lungs and also in the brains " . The

toxicologist states that platinum that is processed in

the implants " one of the most danegrous substances is,

that mankind has ever made...It destroys the

nerves-system " . Lykissa is convinced that women become

sick due to the implants: " and what is making them

sick is the platinum tha comes in their body. I do not

say that all women with silicone implants become sick,

but if you leave those things in more than ten years I

ensure you that you have a very large chance of

becoming sick " thus professor Lykissa. The chance on

this danger is endorsed by dutch plastic surgeon Rita

Kappel of the dutch University Medical centre St.

Radboud in Nijmegen. Thousands of Dutch women with

silicone implants have considerable health problems.

Kappel treats much of these women. She says: Silicone

breasts are for some women unsafe, very unsafe. If I

remove the implants frequently all complaints

dissappear. "

'Knevel op Zaterdag' spoke in Washington with the

american epidemiologe Zuckerman. She stood in

1992, on the basis of the prohibition on the cosmetic

use of silicone implants in the United States. Then

was also in the Netherlands already discussion

concerning risks of it. Zuckerman is considered

worldwide as thé expert in the field of silicone

implants. She does not understand that these in the

Netherlands can still be used: " What are you doing ? I

know all studies and they give reason to large

worries. There is absolutely no scientific proof that

silicone implants are safe zijn. " Zuckerman presents

also very recent research of the American cancer

institute. That indicates on an increased risk of all

kinds of forms of cancer at women with

siliconenbreats.

In the Netherlands the Healthcouncil

('Gezondheisraad', http://www.gr.nl/ , info@... ) in

1999, put in a recommendation that adequate

information to potential weares of silicone implants

is essential. Then minister of Public Health Els Borst

took over this recommendation and obliged the

implant-sector to comply. 'Knevel op Zaterdag'

examined it is obeyed by the clinics. This way a

female editor visited a number of private clinics

which implant silicone breasts for a consult. She

observed that the informative-consult on many points

was short. There was insufficiently indicated on

possible risks. Also on their Internet websites and in

information brochures the clinics proved regularly

shortage. The President of plastic surgeons

association, dr. Hage reacted disappointed to the

facts: " It grieves me very and I will return as a

President with this information to my members and once

again emphasising that this obviously occurs and that

this should not occur " . The ministry of Public Health

did not want to react in the broadcasting to the

observed findings by 'Knevel op Zaterdag'.

Dutch SOURCE -

http://www.eo.nl/portals/programs/episode.jsp?episode=5473655

VIEW the broadcasting - Real Player -

http://www.eo.nl/mediaController?bitrate=broadband & format=ram & fragment=6735106

-------------------------------------------------------------

A World Leader in Implant Research

ph K.McLaughlin, PhD - jkm@...

Journal of Long-Term Effects of Medical Implants,

14(5)341–346 (2004)

By Blot, International Epidemiology Institute

blotw@...

Objective - To describe the key contributions of Dr.

ph K. McLaughlin, Outstanding Scientist of 2004 -

Conclusions - Dr.McLaughlin's seminal investigations

have provided reassurance that breast and other

implants have not demonstrably increased the risk of

cancer or other systemic diseases. The comprehensive

and rigorous nature of this research merits his

selection as Outstanding Scientist of 2004 .....

http://www.iei.ws/images/JLT1405-341-346(236).pdf

Complications of silicone breast implants include all

except

Finding on implant displaced views on screening

mammogram

Appl Radiol Online 3(10), 2004, Gordon, M.D.,

Ph.D., 27 october 2004

http://www.medscape.com/viewarticle/491490_print

Second Thoughts

Choosing breast implant size: a matter of aesthetics

L. Baker MD, Aesthetic Surgery Journal,

November-December 2004

The author chooses breast implant volume by balancing

the patient's preferences with the limitations imposed

by her body type. To achieve the best results, he

relies on his aesthetic sense rather than complex

measurements, but he recommends general guidelines...

http://www.sciencedirect.com/science?_ob=ArticleURL & _udi=B6W9G-4F1GHBS-H & _coverD\

ate=12%2F31%2F2004 & _alid=349840466 & _rdoc=1 & _fmt= & _orig=search & _qd=1 & _cdi=6682 & _s\

ort=d & view=c & _acct=C000050221 & _version=1 & _urlVersion=0 & _userid=10 & md5=933fff7a5c\

039ade8c0e5214757319e6

A Chemist Heats Up Dow Corning

CEO Burns is driving income gains and a new focus on

high-growth markets

Businessweek, by Arndt

micheal_arndt@... - 6 december 2004

In 1967, when chemist Shailer L. Bass retired as chief

executive of Dow Corning Corp., A. Burns was

a seventh-grader in Ann Arbor, Mich., who spent her

days dreaming about becoming a scientist...........

http://www.businessweek.com/magazine/content/04_49/b3911089.htm

2005

Cosmetic Use of Injection Silicone Oils;

Food and Drug Law

Professor Barton Hutt - Paper Submitted in

Satisfaction of Course Requirement and MPA/MC Reading

and Research Requirement - January, 2005

Nearly 11.9 million cosmetic surgical and nonsurgical

procedures were performed in the United States in

2004. Injection of fillers is the number one

increasing procedure, with an increase of up to 659%

of procedures compared to the year 2003. Since all

filler materials are foreign to the body, basic

requirements of filler includes: safe, legal, good

result, performed by a professional and affordable.

Silicones are man-made synthetic polymers and used in

a wide variety of products as fluids, gels and

rubbers......

http://leda.law.harvard.edu/leda/data/727/Tilleman05.html

Breast implants 'no risk to life'

BBC, UK, 2 January, 2005

Having reconstructive surgery does not reduce the life

expectancy of women with breast cancer, research

suggests. In fact women who had breast implants after

a mastectomy had a lower risk of dying from cancer,

the study involving 5,000 patients over 12 years

found......

http://news.bbc.co.uk/2/hi/health/4117577.stm

$7000 payout for a life ruined

The Sun-Herald, By Cuming - January 23, 2005

Kate Wyllie is one of 1800 Australian women who will

receive as little as a few hundred dollars for their

pain and suffering from ruptured and leaking silicone

breast implants..........

http://www.smh.com.au/news/National/7000-payout-for-a-life-ruined/2005/01/22/110\

6334260097.html

Thigh augmentation:

Submuscular placement of a silicone gel-filled

prosthesis

Case Report, Aesthetic Surgery Journal,

January-February 2005, Anger MD

The development of silicone prostheses for

augmentation of the calf and buttocks has led a small

number of our patients to consider the use of implants

for aesthetic thigh augmentation. In this article, we

report a new thigh augmentation technique using

submuscular placement of silicone gel-filled

implants...

http://www.sciencedirect.com/science?_ob=ArticleURL & _udi=B6W9G-4FH4HS7-C & _coverD\

ate=02%2F28%2F2005 & _alid=349840292 & _rdoc=1 & _fmt= & _orig=search & _qd=1 & _cdi=6682 & _s\

ort=d & view=c & _acct=C000050221 & _version=1 & _urlVersion=0 & _userid=10 & md5=c4269ef755\

d6fa1d5a1a2cd1c3198741#m4.cor*

The Lancet: Infection in breast implants

Joe Santangelo j.santangelo@...

The Lancet Infectious Diseases, 1 february 2005, pages

94-106

Breast augmentation is the most frequent type of

plastic surgery done in the UK and--after nose

reshaping and liposuction--it is the third most common

cosmetic procedure in the USA. However, infection

complicates 2–2.5% of breast implantations, and is the

leading cause of illness following such surgery. The

comprehensive review in The Lancet Infectious Diseases

of infection of breast implants is particularly timely

in light of the recent call for tighter regulation of

the private cosmetic surgery industry in the UK.

........

http://www.eurekalert.org/pub_releases/2005-02/l-iib020105.php

http://www.medicalnewstoday.com/medicalnews.php?newsid=19472

Infection risk of breast implants

BBC, UK - 5 February, 2005

Women undergoing breast implant surgery have a 2.5%

risk of suffering a post-op infection, a worldwide

study of 10,000 people suggests. And for cancer

patients having breast reconstruction the risk is up

to 10 times higher, the University of Geneva Hospitals

in Switzerland http://www.hug-ge.ch/

said.... http://news.bbc.co.uk/2/hi/health/4226577.stm

Dow Corning: Silicone Biomaterials History

....oped and tested their silicone gel–filled breast

implant in 1961. They implanted the first pair in a

woman in 1962 (Cronin and. Gerow, 1963).....

http://www.dowcorning.com/content/publishedlit/52-1069-01.pdf

'Natural' breast implant advance

By - BBC News health reporter, in

Washington DC - 17 february 2005

US scientists say they have made a breakthrough to

produce natural breast implants using human stem

cells. .....

http://news.bbc.co.uk/2/hi/health/4274171.stm

High Rate of Failure Estimated for Silicone Breast

Implants

New York Times, By Gardiner - April 7, 2005

WASHINGTON, April 6 - In documents made public on

Wednesday, health regulators estimated that up to 93

percent of silicone breast implants ruptured within 10

years. The surprisingly high figure will further roil

a debate next week about whether to lift the

13-year-old ban on silicone implants for breast

enhancement....

http://www.ebreastaug.com/fda/silicone-breast-implants-failure.htm

FDA Releases Information

from Mentor's Silicone Gel Breast Implant Approval

Application

Cosmetic Medicine / Plastic Surgery News - 13 Apr 2005

http://www.medicalnewstoday.com/medicalnews.php?newsid=22764

FDA Panel Opposes Silicone Gel Implants

The Washington Post, By Marc Kaufman -

kaufmanm@...

April 13, 2005

A Food and Drug Administration expert panel voted

narrowly yesterday against allowing silicone gel

breast implants back on the market for general use,

saying the available scientific data are too scant to

provide assurance that newer versions would be safe.

After two days of emotional and technical testimony,

the panel decided 5 to 4 not to recommend that the

agency overturn its 1992 partial ban on the

implants...

http://www.washingtonpost.com/wp-dyn/articles/A48597-2005Apr13.html

FDA urged to approve new implants

Later versions found safer, more durable

Associated Press, By Neergaard - 14 April 2005

In a surprising turnaround, federal health advisers

yesterday recommended allowing silicone-gel breast

implants to return to the U.S. market after a 13-year

ban on most uses of the devices - but only under

strict conditions that will limit how easily women can

get them........

http://www.signonsandiego.com/uniontrib/20050414/news_1n14implants.html

FDA panel backs breast implants from one maker

New York Times - 14 April 2005 - By Gardiner

GAITHERSBURG, Md., April 13 - Silicone breast implants

made by a California company should be available to

women who undergo cosmetic breast surgery, a federal

advisory panel voted on Wednesday, rejecting arguments

about serious health problems. The panel chairman

called the 7-to-2 vote to approve an application by

the company, the Mentor Corporation, unexpected. On

Tuesday, the panel voted, 5 to 4, to reject a similar

application from the Inamed Corporation......

http://www.center4research.org/news/fda-implants-2005.html

http://www.washingtonpost.com/wp-dyn/articles/A50947-2005Apr13.html

No scientific consensus on silicone breast implants

Health Risk or a Woman's Choice?

USNews.com, By Querna

healthbriefs@... - 25 april 2005

Both Carolyn Wolf and Michele Columbo came to the Food

and Drug Administration's advisory panel meeting on

breast implants last week with strong feelings about

the availability of silicone implants.......

http://www.usnews.com/usnews/health/articles/050425/25breast.htm

Breast implant maker accused of cover-up

Associated Press, May 23, 2005

WASHINGTON - Two former employees of a breast-implant

manufacturer alleged the company covered up high

rupture rates and workers were so fearful of bosses

finding defective implant parts that they hid the

parts in the ceiling. The allegations are contained in

a 2003 lawsuit against the Mentor Corp..

http://www.yourlawyer.com/articles/read/9753

Whistleblowers " Implant Manufacturer engaged in

Cover-Up "

May 25, 2005 , Newsinferno.com

Two former employees of Mentor Corp., a manufacturer

of breast implants, have come forward with allegations

that the company covered up evidence of high rupture

rates and that workers would hide defective parts in

the ceiling to avoid detection by their superiors.

These former employees claim that senior executives in

the company told them to destroy reports detailing

high rupture rates and that packaging for the implants

was sometimes infested with fleas. The actual rupture

rates far exceeded those reported to authorities

according to one of the whistleblowers. A criminal

investigation of Mentor was closed in 2002 and

recently the company won a recommendation from federal

scientific advisors that it be permitted to resume

sales of its implants under certain conditions.

( SOURCE -

http://www.yourlawyer.com/articles/read/9807 )

Silicone suits crawl along

Thousands await money years after implant maker

pledged $2.35 billion

Dallas Morning News, Texas, By Sherry son -

sjacobson@...

28 May 2005

It's been 25 years since Dintino [statement of

Dintino - FDA Panel Hearings - October 2003 -

http://www.gyxe.com/breast-implant/7-625-statement-of-linda-dintino-fda-panel-he\

arings-october-2003-read.shtml

] got silicone breast implants and more than a decade

since she sued the manufacturer, Dow Corning Corp.,

believing the devices made her sick. But she and tens

of thousands of other women haven't received a penny

despite the promise of a $2.35 billion settlement by

the implant maker in the mid-1990s. The company began

compensating breast implant wearers last June after

emerging from Chapter 11 bankruptcy. But most of the

women are still waiting...

http://noticias.vanguardia.com.mx/showdetail.cfm/460983/Silicone-suits-crawl-alo\

ng-/

'DIY' breast implants may be on the horizon

March 28 2005

London - A revolutionary technique using stem cell

research could soon allow women to choose breast

enhancements made of living tissue instead of

silicone...

http://www.int.iol.co.za/index.php?set_id=1 & click_id=31 & art_id=vn200503280808319\

46C969735

Fungal contamination in breast implant surgery:

A rare, preventable complication

Cosmetic Medicine/Plastic Surgery News - 03 Jun 2005

Contact - Steve Baragona sbaragona@...

703-299-0412

Infectious Diseases Society of America

http://www.idsociety.org

Although apparently uncommon, fungal contamination of

saline-filled breast implants is readily preventable,

according to a study in the July 1 issue of The

Journal of Infectious Diseases, now available online.

The key steps are to use closed systems for filling

the devices and to adhere to the strict moisture

control and operating room ventilation standards in

force at major hospitals.......

http://www.medicalnewstoday.com/medicalnews.php?newsid=25552

Breast Implant Claims

M. Frailich smflawcorp@...

Owner of the Law Offices of M. Frailich

A Professional Law Corporation, has been a practicing

attorney for the past 25 years. Mr. Frailich has

specialized in Personal Injury Litigation and Breast

Implant Class Action claims, and has obtained more

then $75,000,000 in settlements on behalf of his

clients. Mr. Frailich is presently specializing in

handling Breast Implant Class Action Claims, and has

successfully settled over 600 claims. He is able to

assist any claimants who do not understand if they are

eligible to receive any compensation in the Class

Action or who are having problems settling their

implants claims with the Claims Board.......

http://www.frailichlaw.com/

Breast, Implant Rupture

eMedicine.com , June 10, 2005

L Hallett, MD, Consulting Staff, Department of

Radiology, Riverview Hospital

......An estimated 1-2 million patients, or

approximately 1% of the adult female population, have

breast implants. The incidence of implant rupture

increases over time. One recent study revealed that

the median lifespan of a SGBI is 16.4 years. In that

study, 79.1% of implant were intact at 10 years; the

percentage decreased to 48.7% at 15 years........

http://www.emedicine.com/radio/topic112.htm

Study: Silicone breast implants may be contaminated

REUTERS HEALTH, By Will Boggs, MD - 15 July 2005

NEW YORK - Five cases of fungal contamination of

saline-filled breast implants were likely caused by

poor infection control measures during the implant

procedures and in the operating room, according to a

report. According to investigators, black sediment was

seen in the implants of five women who had undergone a

second surgery to correct various problems they were

having with their breast implants. A fast-growing

fungus found in soil called Curvularia fungus was

isolated from the saline in the removed implants, Dr.

n A. Kainer marion.kainer@..., from the

Tennessee Department of Health in Nashville, and

colleagues report in The Journal of Infectious

Diseases........

http://www.ebreastaug.com/breast-implant-news/silicone-implants-contamination.ht\

m

Mentor shares advance on FDA letter

AP - By Wallance Witkowski - Business Writer - July

29, 2005

Shares of medical device maker Mentor Corp. opened

above their 52-week high and kept climbing Friday

after the company received an " approvable letter " from

the Food and Drug Administration to bring silicone-gel

breast implants back to the market after 13 years....

http://www.forbes.com/associatedpress/feeds/ap/2005/07/29/ap2164561.html

Regarding Petitions to Block

FDA Approval of Silicone Gel Breast Implants

Public Citizen's Health Research Group - Statement of

Sidney M. Wolfe, M.D.,

August 9, 2005

The fundamental questions are: (1) Are silicone gel

breast implants safe, and (2) Have the companies done

studies that provide reasonable assurance of safety as

required by FDA regulations and guidances?.....

BREAST IMPLANT CHRONOLOGY .....

1988: Public Citizen files a petition to ban silicone

gel breast implants....

1992: FDA moratorium on silicone gel implants....

1998: Public Citizen testimony before Instituteof

Medicine(IOM)..

1999: IOM Recommendations..

http://www.citizen.org/publications/release.cfm?ID=7397

FDA urged to hold off on approving silicone-gel

implants

By Rita Rubin, USA TODAY - 10 August 2005

[ Health and Behavior Reporters - kthomas@...

]

A coalition of health advocacy groups urged the Food

and Drug Administration on Tuesday to refrain from

approving silicone-gel breast implants until the

manufacturer provides long-term data about the

devices' safety..

http://www.usatoday.com/news/health/2005-08-09-breast-implants-fda_x.htm

Tits for Tat

Bush's FDA moves forward on approving silicone breast

implants but still stalls on emergency contraception

by Weinstein - 15 August 2005

When a federal Food and Drug Administration advisory

panel recommended the approval of one company's

silicone gel breast implants this spring—even though

some women had testified that the gel oozed out of

their eyes, ears, and nipples—one word kept coming up

over and over again: choice. A panelist told The New

York Times that it was important to give women a

choice of implants......

http://www.villagevoice.com/news/0533,weinstein,66885,6.html

Mother tells how hospital removed Healthy breast

News Scotsman - JAMES HALL - 5 Sep 2005

A MOTHER has revealed how she had a healthy breast

removed after being wrongly diagnosed with cancer.

Marjory , 52, was told by doctors - over the

phone - that she had a rare and aggressive form of

cancer and that she needed a mastectomy. Less than a

month later, doctors at Raigmore Hospital, Inverness,

admitted they had been looking at another patient's

tissue sample and made a mistake. It took nearly two

years for Highland Acute Hospitals NHS Trust to offer

Mrs just £44,000 compensation..

http://news.scotsman.com/scotland.cfm?id=1891152005

FDA endorses 2d firm on Silicone Implant sales

Boston Globe, Massachusetts. 22 September 2005

By Diedtra , Globe Staff -

dhenderson@...

The Food and Drug Administration yesterday told a

second manufacturer it is willing to approve wider

sales of its silicone gel-filled breast implants....

http://www.boston.com/business/globe/articles/2005/09/22/fda_endorses_2d_firm_on\

_silicone_implant_sales/

MPs call for removal of

Health Canada's breast-implant panel members

Eggertson eggerts@... with files from

Sally Murray, CMAJ

November 8, 2005; 173 (10). doi:10.1503/cmaj.051329.

Opposition MPs are calling on Health Canada to remove

members of an expert advisory panel on breast

implants, or to suspend the panel's work, because at

least 3 members have ties to manufacturers of the

medical devices....

http://www.cmaj.ca/cgi/content/full/173/10/1144

Reprieve For Breast Implants

Their safety is unproved, but it's tough to ban

something already used by 2 million U.S. women - TIME,

By Michale D. Lemonick - Nov 11, 2005

http://www.time.com/time/archive/preview/0,10987,1101911125-155969,00.html

Zonyl Packaging Whistle-blower:

DuPont Knows Food-Packaging Risk

Jack Kaskey jkaskey@... Bloomberg News, 17

nov 2005

DuPont Co., the third-largest U.S. chemical producer,

is tainting candy, butter, popcorn and baked goods

with a potentially cancer-causing chemical that seeps

out of grease-resistant packaging, a former company

scientist said yesterday...................

http://www.mindfully.org/Plastic/Teflon/Zonyl-DuPont-Risk17nov05.htm

'Gummy Bear' Breast Implants Inch Closer To U.S.

Makers Hope Silicone Implants Will Be Approved In U.S.

November 22, 2005

BETHESDA, Md.- A new type of breast implant already

available in other countries may soon be making its

way to the United States....

http://www.nbcsandiego.com/health/5381622/detail.html

Want breast implants? Do research first

Knight Ridder Newspapers, By Garloch

kgarloch@...

Dec. 02, 2005

Naked from the waist up, Sharon Eller endured the

medical exam by avoiding the eyes of two men staring

at her breasts. Dr. J.P. Riou backed up for a better

look. He tipped his head toward Sharon's husband,

Maurice, and pointed out that her right breast hung

lower than her left. Women's breasts rarely match, the

plastic surgeon said. But he could fix

that................

http://www.fortwayne.com/mld/newssentinel/living/13310663.htm

Breast reconstruction with implants:

no survival disadvantage

Nature Clinical Practice Oncology (2005) 2, 64doi:

10.1038 / ncponc 0089

Responding to concerns about the possible adverse

effects of breast implants after mastectomy, Le et al.

have recently published the results of their large,

population-based study. Breast implants did not appear

to confer any survival disadvantage; in fact, the

long-term risk of breast cancer mortality was lower in

women with implants than in those without... [Full

text available with e.g. Personal subscription ]

http://www.nature.com/ncponc/journal/v2/n2/full/ncponc0089.html

Blowing the whistle on Mentor

PUBLIC RADIO, 5 December 2005

Silicone breast implants are stirring up controversy

again. An ex-employee of implant maker Mentor claims

the company misrepresented safety data and chose not

to fix a problem with their implants. From the Health

Desk at WGBH, Helen Palmer reports - LISTEN to this

story -

http://www.publicradio.org/tools/media/player/marketplace/2005/12/05_mpp?start=0\

0:00:01:09.0 & end=00:00:03:16.0

FDA Not Concerned by Mentor Claims

LATIMES, December 6, 2005, from Reuters

Allegations from a former Mentor Corp. engineer about

possible leakage from the company's silicone breast

implants are not a concern to regulators weighing

whether to approve expanded sales, a Food and Drug

Administration spokeswoman said Monday..........

http://www.latimes.com/business/la-fi-mentor6dec06,1,7265271.story?ctrack=1 & cset\

=true

Did Mentor only fix some implants ?

December 6, 2005

NEW YORK (CNNMoney.com) - The maker of a silicone

breast implant awaiting final approval from the Food

and Drug Administration allegedly sought to limit

leaks of silicone oil from sample implants sent to

doctors' offices, but no adjustments were made to

devices that would actually be implanted in women,

according to a published report...

http://money.cnn.com/2005/12/05/news/midcaps/mentor_implants/

New Findings on Mentor Corporation Reveal

Further Disdain for Women's Health

NOW.org, December 6, 2005

News that breast-implant manufacturer Mentor Corp.

corrected a malfunction in the samples it provides to

doctors—but did nothing to repair the implants that

will be placed in women's bodies—provides further

proof that the company puts profits first, and that

the FDA must take decisive action against Mentor to

protect women's health and safety, said National

Organization for Women President Kim Gandy......

http://www.now.org/press/12-05/12-06.html

Breast-implant 'bleeds' studied

Implant Maker Fixed Samples Only

Informer Highlighted Problem With Silicone Devices,

Which Await FDA Approval

The Washington Post, By Marc Kaufman

kaufmanm@..., Staff Writer

December 6, 2005

WASHINGTON - Mentor Corp., which hopes to win Food and

Drug Administration approval soon to sell its

silicone-gel breast implants for general cosmetic use,

faced a problem last year as it prepared to distribute

to doctors the demonstration models that prospective

customers would try on for size: The implants

sometimes left behind an unsettling slick of silicone

oil...........

http://www.newsday.com/news/health/ny-hsimp064540829dec06,0,173485.story?coll=ny\

-health-headlines

http://www.washingtonpost.com/wp-dyn/content/article/2005/12/04/AR2005120400887.\

html

Whistleblower Alleges Defects in Silicone Implants

Feminist Daily News Wire - December 7, 2005

A former employee of Mentor Corporation, manufacturer

of silicone breast implants, came forward this week

alleging that the company corrected leakage defects in

doctors' samples, but not in implants intended for use

in women's bodies. The whistleblower sent a letter to

the Food and Drug Administration (FDA), which issued

an approvable letter for the implants in July, stating

" I am very concerned about the safety of women using

these breast implants if they were to become widely

available as an FDA-approved product, " reports the

Washington Post................

http://www.feminist.org/news/newsbyte/uswirestory.asp?id=9415

An example of spirit, courage

By: Greg Scharf Gscharf7@..., The Californian, 8

december 2005

....She was a single mom, with three young kids, and

she said that she'd recently been diagnosed with Stage

3 breast cancer and would like a friend for support

and to hang out with between chemo and radiation

treatments.....(...)...Her doctors had told her that

in her case, there was no point to aggressive

treatment ---- she was too far gone. She didn't accept

that, though, and told me she was going to fight until

she was cured or until the day she died. Doctors told

her that the severity of her case was the result of

having breast implants....

http://www.nctimes.com/articles/2005/12/09/opinion/scharf/19_39_0712_8_05.txt

Study suggests infections can cause childhood cancer

Associated Press - Dec. 12, 2005

LONDON - Common infections that affect mothers and

babies may trigger certain types of childhood cancers,

researchers said today......

http://www.chron.com/disp/story.mpl/health/3518670.html

42 U.S. Senators hold Stock in Pharma

Up To $16 Million In Drug Company Stock Investments

Conflict

42 U.S. Senators Out of Vaccine Vote, Says FTCR

13 december 2005

Carmen Balber - carmen@...

Court - jamie@...

http://www.consumerwatchdog.org

SANTA MONICA, Calif., Dec. 13 /U.S. Newswire/ --

Forty-two U.S. Senators hold stock in pharmaceutical

companies even as they vote on legislation to benefit

the drug industry, according to an analysis released

today by the nonprofit, nonpartisan Foundation for

Taxpayer and Consumer Rights (FTCR). The Senate is

expected to vote this week on an eleventh-hour

amendment to immunize vaccine makers for dangerous

drugs. Senators should not participate in votes from

which they will financially benefit, said

FTCR............

http://releases.usnewswire.com/GetRelease.asp?id=58052

Multimillion-Dollar Penalty Against DuPont Sets a

Record

DuPont fined for hiding Teflon dangers.

Randall Chase rchase@...

The Associated Press - 15 december 2005

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 a toxic

chemical used to make the nonstick coating

Teflon...........

http://www.law.com/jsp/article.jsp?id=1134554714168

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

ternational/

National Silicone Implant Foundation:

http://www.info-implants.com/ALB/Lori/

" If they can do a federal investigation on, DuPont;

who's behind holding up a federal investigation into

the Breast Implant / asbestos / gulf war, etc, scam

and cover up, that's harmed millions of us ? We have

the data an evidence to prove, Dow Chemical and the

rest of the Breast Implant Manufactures all lied an

are Guilty ! Including, Judges, the Science Panel and

ton's of other's involved in this crime against;

human's used as guinea pigs without our Informed

consent. What do they call the toxic chemicals used in

breast implants, duh ? Many are banned because they

are carcinogenic. To bad the rats and beagles, Dow

used can't blab cuz they all croaked, but, we can

exposed Dow's evil bogus lies. The Toxic chemicals in

breast implants cross the placenta barrier to the

children. Dow, knew too, and chose to poison You and

our children for money $$ !! "

Study suggests viral infection cancer link

Scientist " Colds or mild flu trigger a certain form of

cancer in susceptible children "

16 December 2005

A study of 3000 childhood cancers spread across five

decades has revealed distinct " space-time " clusters

for a form of childhood leukaemia, indicating that

viral infections are playing a role. A pre-existing

abnormality must also have been present in the

infected children. ............

http://www.stuff.co.nz/stuff/0,2106,3513184a7144,00.html

DuPont won't say how C-8 is formed

The Wilmington News Journal, By Jeff Montgomery

jmontgomery@...

18 December 2005

The Environmental Protection Agency wants to know a

lot more about the fate and breakdown of chemicals the

DuPont Co. makes or sells for use at its Chambers

Works plant in New Jersey and other sites around the

globe to make nonstick, nonstain, grease-repellent

products...........

http://www.delawareonline.com/apps/pbcs.dll/article?AID=/20051218/NEWS/512180321\

/-1/NEWS01

Complications Common With Postmastectomy Breast

Reconstruction

Arch Surg 19 december 2005; 140:1152-1159.

NEW YORK (Reuters Health) - Reconstructive breast

implantation performed after mastectomy to treat

breast cancer is associated with a high rate of

adverse events that often require surgical

intervention, results of a prospective study

suggest....

http://www.medscape.com/viewarticle/520112

Women who undergo reconstructive breast implantation

frequently develop short-term complications

JAMA and Archives Journals, Howser, 19 December

2005

Almost one-third of women who underwent reconstructive

breast implantation after mastectomy had at least one

short-term complication in the chest or breast area,

with one in five women requiring additional surgery,

according to a study in the December issue of Archives

of Surgery, one of the JAMA/Archives journals.

http://www.eurekalert.org/pub_releases/2005-12/jaaj-wwu121505.php

Breast Implant Complications Frequent, Study Finds

CONSUMER AFFAIRS, December 19, 2005

Almost one-third of women who underwent reconstructive

breast implantation after mastectomy had at least one

short-term complication in the chest or breast area,

with one in five women requiring additional surgery,

according to a study in the December issue of Archives

of Surgery. The most common complications were

infection, blood clotting, seroma (collection of serum

in the tissues) and skin perforation. Forty-nine

percent of these complications occurred within three

months and 67 percent within six months.........

http://www.consumeraffairs.com/news04/2005/breast_reconstruction.html

Breast Augmentation: A Public Health Perspective

By Zuckerman, PhD - dz@...

National Research Center for Women and Families -

http://www.center4research.org/

info@...,cpr4wf@...

2005

http://www.coolnurse.healthology.com/printer_friendlyAR.asp?b=coolnurse & f=surger\

y & c=risks_breastsurgery

Statement of Dr. Zuckerman,

Ph.D. President, National Research Center for Women &

Families

Reconstructive Breast Implantation After Mastectomy

for Breast Cancer

WASHINGTON, Dec. 19 2005 - PRNewswire - Dr.

Zuckerman, Ph.D. issued the following statement

regarding today's release of the article

" Reconstructive Breast Implantation After Mastectomy

for Breast Cancer " in the journal Archives of Surgery:

.......

http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104 & STORY=/www/story/12-19-200\

5/0004236711 & EDATE=

Settlement reached between DuPont and EPA

Great Lakes Radio Consortium, Michigan. 19 December

2005.

The Environmental Protection Agency says DuPont hid

information about the dangers of a chemical used to

manufacture Teflon. The allegations prompted an

investigation by the EPA, and now, the company will

pay 16.5 million dollars to settle the complaint. The

EPA says it's the largest administrative penalty it

has ever won......

http://www.glrc.org/story.php3?story_id=2875

Implants, mastectomies linked to problems

Study: Post-mastectomy implants pose an added risk

By Lindsey Tanner ltanner@... - Associated Press -

Dec. 20, 2005

CHICAGO - Breast implants in women who have undergone

mastectomies often result in complications that

require more surgery, a study in Denmark has

found.........The study appears in the December issue

of Archives of Surgery. It was paid for by the

institute, which receives funding from the Dow Corning

Corp., a former maker of silicone breast

implants.......

http://www.philly.com/mld/philly/living/health/13445512.htm

http://24hour.startribune.com/24hour/healthscience/story/2990486p-11672159c.html

Women Who Can't Get Breast Implants Have Another

Option

WBAL Channel.com - December 27, 2005

BALTIMORE -- One in eight women will develop breast

cancer, according to health experts. Those who have

mastectomies often have breast reconstruction,

reported WBAL-TV in Baltimore. Now women might have

another reconstruction option. Three years ago,

Kathleen was diagnosed with breast cancer. After

a mastectomy, she opted for a breast implant, but

later began having neck pain. " I also was experiencing

a lot of tightness on the right side of my torso,

which is where I had the mastectomy and

reconstruction, " said....

http://www.thewbalchannel.com/dietandfitness/5585782/detail.html

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