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Silicone Breast Implants: Overview ( 1989 - 2005 )

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Thanks very much to a good friend of ours who sent this:

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=9D0CEEDC1338F937A25757C0A967958260 & 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=9D0CE1DE1F3AF935A25756C0A967958260 & 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_247

7000/2477901.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 & sea

rchid=1128410605620_166 & stored_search= & 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-WALL%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= & author=Hellwege%2C%

20& title=Breast%20implant%20litigation%20faces%20uncertain%

20future. & date=07/01/1995 & refid=ency_botnm

SEE ALSO / MORE -

http://www.encyclopedia.com/html/b1/breastim.asp

What Dow Corning Knew.. & ..When Dow Knew It

Fact Long Suppressed About The Dangers of Silicone!

http://www.siliconeholocaust.org/whatdowknew.html

Breast Implants: A Study in Phantom Risks

Research Memorandum, by E. Bernstein dbernste@... -

April 1995

March 1, 1995, marked the final day women who believe they were

harmed by silicone gel breast implants could register for a share of

the $4.25 billion class-action settlement that plaintiffs' attorneys

had won from implant manufacturers. Some 400,000 women had

registered by the deadline.

http://www.manhattan-institute.org/html/research_memorandum_5.htm

Makers offer plan to save implant deal

Houston Chronicle, By Flynn - 2 october 1995

Three breast implant makers Monday submitted a tentative

restructuring plan for the doomed global class-action implant

settlement, but attorneys for some implant recipients were skeptical

of the proposal...

http://www.chron.com/content/chronicle/metropolitan/95/10/03/implant.

html

Decision on implant cases goes against Dow Chemical

Houston Chronicle, By Flynn - 2 november 1995

A Texas Supreme Court ruling Thursday opened the door for Dow

Chemical Co. to be tried separately from Dow Corning Inc. on

thousands of state lawsuits by breast implant recipients

http://www.chron.com/content/chronicle/metropolitan/95/11/03/implants

..html

Implant arguments set

" .....Dow Chemical did not design, manufacture or sell any breast

implants, said Houston lawyer phson...... "

http://www.chron.com/content/chronicle/metropolitan/95/10/11/state.ht

ml

SEE ALSO -

http://www.chron.com/cgi-

bin/auth/story/content/chronicle/page1/97/08/26/implants.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+breast+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.html

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-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.html

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.view & 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.htm

l

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.html

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=9B02E5DC153BF931A35751C1A96E958260 & 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 & _coverDate=07%2F31%

2F2000 & _alid=349839321 & _rdoc=1 & _fmt= & _orig=search & _qd=1 & _cdi=6887 & _so

rt=d & view=c & _acct=C000050221 & _version=1 & _urlVersion=0 & _userid=10 & md5=

2abe00c35f7db3d68e866a6d3c0b7d9b

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_e

n.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_disease.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/dailys/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/3

08/1032202.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=qw985532581457B243

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=qw985532581457B243

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/3

08/30803.htm

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/Noona

n-Saraceni730print.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/en/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/m

320en.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=TOC2 & 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 & LEVEL=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/emil

ysenay/main578049.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 & Month=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/2004-04-19/041920043334895W.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-

19/041920043331195W.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.h

tml

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_breastimplants

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/messa

ges/46343.html

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

[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 & _coverDate=12%2F31%

2F2004 & _alid=349840466 & _rdoc=1 & _fmt= & _orig=search & _qd=1 & _cdi=6682 & _so

rt=d & view=c & _acct=C000050221 & _version=1 & _urlVersion=0 & _userid=10 & md5=

933fff7a5c039ade8c0e5214757319e6

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/2005/01/22/1106334260097.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 & _coverDate=02%2F28%

2F2005 & _alid=349840292 & _rdoc=1 & _fmt= & _orig=search & _qd=1 & _cdi=6682 & _so

rt=d & view=c & _acct=C000050221 & _version=1 & _urlVersion=0 & _userid=10 & md5=

c4269ef755d6fa1d5a1a2cd1c3198741#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.ht

ml

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-hearings-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-along-/

'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=vn20050328080831946C969735

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.htm

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.h

tml

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=00:00:01:09.0 & 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/International/

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=surgery & 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/12-19-2005/0004236711 & 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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