Fw: Silicone Breast Implants - Overview

May 5, 2006

this is a bit long but lots of great info.

I know some have ask me if penni implants are saline or silicone . She had saline.

god bless michele

**Possible_Spam** Silicone Breast Implants - Overview

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_2477000/2477901.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 & searchid=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 -

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.html

European Commission Guidelines Implants

Guidelines for conformity assessment of Breast Implants -

Acoording to Directive 93 / 42 / EEC relating to Medical Devices - July 1998

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

Breast implant operations increase, despite controversy

CNN, July 8, 1998

Women are getting breast implants in record numbers, despite the negative publicity the surgery has received in recent years.

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

An Atypical Complaint:

Science v. Subjectivity in Breast Implant Litigation

Making People: The Normal and Abnormal in Constructions of Personhood

Xandra Rarden xrarden@... ? and Sheila Jasanoff sheila_jasanoff@...

Cornell University - July 1998 ?

Abstract - Competing scientific accounts have emerged in the debate over whether silicone gel breast implants cause autoimmune disorders. The mainstream story, told principally by epidemiological researchers at leading medical institutions, denies any causal connection between the devices and traditional forms of the disease. The alternative story, told by plaintiffs and their treating physicians, posits the existence of an "atypical" disease, whose symptoms are fully understandable only to those willing to heed the plaintiffs' subjective experiences. In this paper, we examine the scientific contestation around the attempted construction of an "atypical" disease entity. We ask how the cultural context of litigation molded and shaped the mainstream and alternative scientific stories, influencing the production of different forms of collective knowledge. Interactions among judges, lawyers, scientists, doctors, the media, and social activists all contributed to this process. We show how mainstream science eventually ratified the safety of the implants, while discarding or setting aside the alternative hypothesis. Although a powerful social movement coalesced around the "atypical" disease claims, knowledge derived from personal and group experiences failed to make headway against the claims of objective science. Yet, allowing orthodox scientific practice systematically to dominate over other types of meaningful knowledge production may not be the best the way to bring closure to such controversies. Instead, we need to search for mechanisms that strike a better balance between scientific and subjective knowledge in toxic tort litigation.

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

UK Minister of Health

Report Silicone Gel Breast Implants "No evidence disease"

The Report of the Independent Review Group (IRG)

Professor D Sturrock RDSturrock@...

July 1998

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

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

Jury still out on silicone breasts

BBC, UK - July 13, 1998

A government panel has rejected claims that silicone breast implants cause long-term sickness, but has called for stricter controls over their use...

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

Breast implants are cleared of causing Disease

Daily Telegraph, By Celia Hall, Medical Editor - 15 July 1998

The Government accepted a package of recommendations yesterday to regulate silicone breast implant surgery and protect the 8,000 women who seek the cosmetic operations every year.

The independent review ordered by Baroness Jay, the health minister, could find no scientific evidence to link the silicone implants with abnormal immune response or the development of diseases such as arthritis, as has been claimed..........

http://www.telegraph.co.uk/htmlContent.jhtml?html=/archive/1998/07/15/nbre15.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 & _sort=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_en.doc

Breast implant advice from government

BBC, UK - 4 October, 2000

Women considering having breast implants are to have access to objective advice from a booklet written by the Department of Health. The booklet aims to ensure women have all the information they need before surgery, while the debate about the safety of implants continues. Its release coincides with publication of research from the US National Cancer Institute which concludes that having implants is not linked to breast cancer risk.... http://news.bbc.co.uk/1/hi/health/956247.stm

One in seven breast implant patients have complications

The Independent - 5 October 2000

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

One in seven women experience problems after breast implant operations, says a government booklet detailing the dangers. For the first time women are being provided with information about the risks attached to each of the different types of breast implants available. The booklet, published by the Department of Health today, will be distributed to clinics, doctors and patient support groups. The information covers the four types of breast implants available in the UK: Silicone Gel, Saline, Hydrogel and Polyvinyl pyrolidine solution (PVP). The booklet quotes recent evidence in Britain suggesting that one in 10 women with breast implants has had a problem with a hardening of the implant, which causes it to deform and in some cases become painful. (SOURCE- http://www.bnn-online.co.uk/news_datesearch.asp?SearchDate=05/Oct/2000 & Year=2000 )

Scandal of Killer Medical Aids

German company linked to injuries of British patients

15 October 2000 The Observer, UK

In August, 29-year-old accountant Jan Temple responded to a Department of Health urgent warning and had her soya oil breast implants removed. She had learnt that they could cause cancer, kill foetuses and harm breastfeeding babies. The complex and unpleasant operation left her without movement in part of her right arm. Because the soya is a natural product it becomes entwined with the breast tissue and the implants have to be 'ripped out', which can take more than five hours. In many cases the soya becomes putrid and the rancid remains have to be treated as a biological hazard. So far, 1,400 women in Britain have faced this horrific ordeal. But the full story of how thousands of women have been emotionally and physically scarred by these implants is only likely to come out in a US court next year when their American manufacturer faces compensation claims. At the same time, the case will shine light on how faulty medical technologies can easily find approval for use in Europe

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

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

[ free translation ]

Breast - Implants

Dutch Support-Point for women with siliconen implants (SVS)

The foundation SVS is an interest-organisation for women with questions concerning and/or problems by silicone implants, human adjuvant disease (HAD), silicone related disease (SRD). The foundation gives telephone and written information and offers relief. Also she examines the possibilities for prevention and medication. Mission of the SVS - the SVS strive for a prohibition on unlimited use of silicone-gel-filled-implants, the promotion of research, an aid programme for the patients and prevention

Mrs. Marlou Boots

Uitdamstraat 22, 8244 DZ Lelystad Haven

Europe, The Netherlands

- Tel - +0031- 320-264566

- Fax - +0031 - 320-264548

- Homepage - No website yet

This Article was earlier published in magazine 'De Stille Kracht' (The Quit Power) published by SVS.

Silicone litteraly take possession of your body. Marketing inventions, which greedyly are taken up by the medical science. There is then not thought that a crime is being committed on the human body. Marlou the founder of Support Point for Women with Silicone Implants (SVS) tells her own story. A story not only to think about, but litterally yo stand still by.

In 1991, I had my last pocket silicone removed. I was after 18 operations more dead than living. I recovered quit a bit and and started to deepen myself into silicone-literature. Already quickly it became clear to me what the cause had been of my lost years and I placed an add in the newspaper in which I sought fellow-sufferers. The responses was overwhelming and in 1992, I set up the Support Point for Women with Siliconen Implants (SVS). I have answered thousands of phone calls since that time. I have a collection of implants in several states of dissolution, which scares the hell out of you. With the SVS I am meanwhile busy at international level. It is a pity that women let them talk into such a negative self-image. My motto is: "rather flat than a plants".

The ground substance of silicone is silicate-rock (sand). For the filling of prosthesis this undergoes a chemical treatment as a result of which a substance arises that is similar to 'Bison kit' ( brand of a strong thick glue). In principle you can state that implants always keep perspiring, sweating. As a result, the very small particles of those 'Bison kit' are distributed by means of our lymfatisch sytem through the body. With the duration of alwaus sweating it concerns small quantities, but if the implants are going to leak there will come an overdose of silicon in your body. Compare this with a considerable amount of 'Bison kit' on your carpet. It can be no longer cleaned. Silicon, float, they spread themselves through the whole body. In that respect they are comparable with a haze of desert sand - only if you would sweep the grains together, you would see them. At pathological research at women there have been silicon found in each tissue and each organ of the body. Sometimes silicon leave the body by means of the skin. There are also women who have found sannd-grains in their urine. But generally they continue to stay in the body. The molecules are too large to be removed by the kidney-membrane.

The silicon disease (Silicon Related Disease - SRD) is a disorder which damages your immume system. Women who suffer from disease show among others the following complaints - changing muscle - and articular-pain (like rheumatism), demolishing fatigue (like ME), memory impairments, back complaints, neurological complaints, thyroid- and pancreas-disorders, thickening of the skin and allergies. Doctors are in the blue about the causes of this complaints, but they are almost never to be traced, tracked and thus not treatable. The only thing doctors are sure about is that the complaints are NOT caused by silicon. Siliconen would be safe, because they are inertia. This means - not active. Chemically this indeed is correct, but biologically silicon are active. It has been proved scientifically that silicon biologically are not inert and therefore produce impairments in the body. Moreover there are, due to the chemical procede process of silicate to silicon, 39 chemicals (among other things toluene, acetone, formaldehyde, benzene, dichloormetaan - dutch: tolueen, aceton, formaldehyde, benzeen, dichloormetaan) and 8 heavy metal (among other things barium, silver, nickel, chromium - dutch: barium, zilver, nikkel, chroom) hidden in the implants.

What exactly is the wrongdoer, the chemicals or the silicon, is at that moment not yet clear. But the substances always come in combination with each other in your body. And how does your body react then? I myself think that every woman with implantssooner or later will have problems from it. But if woman only get complaints on older, later age (the incubation time can be 20 years) the complaints are slid onto the age. Complaints of younger women according to the doctors mostly are between the ears. On average 3000 implants per year are put in. 26% get within 5 yeras such complaints that another operation is neccessary, particularly the local complications as encase, deforms and movement. After 6-8 years most of the women get changing sometimes still vague health complaints. Of all women ever operated in the Netherlands 10% have meanwhile already communicated themselves at the SVS as a silicon victim. At some women immediately an extreme improvement in health steps up after removal of the implants. The largest group needs 2 up to 5 years for slightly recovery. For a small group unfortunately the 'point or no return ' has been reached and these women die a mysterious death, which is dismissed with declarations such as "the age" or other never determined sicknesses.

Women who get implants always are fortunate with them. They do not think of the possible consequences or do not want to think about it. As long as the doctors are not yet punished, they continue to deny that those small pockets will eventualy leak in the long run and as a result problems can arise. It is than not strange that a woman does not realise inwhich she starts ? Even the so-called safe salt-water prosthesis are risky business. At first, these water-pockets are packaged in an envelope of..........yes,right.....silicon. Moreover that stationary water gets, on a nice temperature in combination with the functioning of your body, very easy infected with bacteria. The silicon-envelope thus always breaths on ! The bacteria are even possible during filling or during the implanting in the operation room ER of coming into the water. The consequence can be guessed - moulds and fungus in your small pocket ! And leakage of these pockets can have deadly impact. Although the complete medical science are aware, informed of all these matters and the use of silicon in America has even been forbidden since 1992, the lords doktors cover themselves in silence. There is a surgeon who has said rockly-hard: "If breast enlarge operations would be forbidden at five o'clock this afternoon, then I will put in my last implant at five to five". And that is now exactly the reason why almost every plastic surgeon keeps its mouth shut. Putting implants in means gold money.

RISKS OF BREAST-IMPLANTS

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

(2) breast implants make own self-research mammography. Several x-rays are necessary, as a result of which more radiation comes in the body every time

(3) torn or leaking implants remain many years' unnoticed, whereas of siliconen it is known that it penetrates the lymfatisch system and has been found at implanted women in the brain, back marrow, uterus, liver and other organs

(4) implants will not live a life long. they must be replaced within 10 years (even without health problems)

(5) there are ALWAYS infecties possibly including moulds and antibiotic resistent bacteria

(6) feeling loss of the breast, especially around the nipples and the nipple court have been mentioned, just like over sensesitivity at contact

(7) astringency (becoming hard of the breast) can be a very unpleasant sense, from very painfull tot misforming

(8) Many woman have different rejection-complaints and other forms of breast-tissue loss

(9) many women have developed serious defence system sicknesses as rheamatism, M.S., Lupus, etc. sometimes already shortly after the implantation. Women with a weak defence system have been now been warned and can better avoid implants

(10) large numbers of of women with implants have reported neurological and well-known complications, but also hormonal troubles, including uterus-removals, miscarriages

(11) many children, born after implantation, appeared to have the same defence system complaints, something which has not yet been studied enough.

(12) breast implants mostly have a negative effect on the milk production at giving breastfeed. Breast feeding is better not to with implants.

(13) Health insurance companies refuse to pay for the routine costs for the woman who have implants and those who had them removed.

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

Silicone Implant Disease

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

........ Now, 38 years later, it is clear that silicon enhancement of breasts can be hazardous to the health of the recipient. The real cost of cosmetic breast enhancement may not be the $10,000 in surgical fees to implant them, but a host of autoimmune symptoms and strange illnesses that can crop up, typically within about seven years of implantation......

http://www.medical-library.net/sites/framer.html?/sites/_silicone_implant_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/308/1032202.htm

Register of breast implants proposed

Daily Telegraph, By nicole.martin@... - 22 march 2001

A register of every silicone breast implant operation in Europe was among proposals put to the European Commission yesterday to help to protect the thousands of women who have the surgery each year.... http://www.telegraph.co.uk/news/main.jhtml?xml=/news/2001/03/22/nimp22.xml

Study gives firm support to breast implants

March 26 2001

Chicago - There is little evidence that silicone breast implants trigger production of an antibody that has been linked to cancer and other diseases, according to a study published on Sunday. In a study of 288 women who had had or still had breast implants, researchers from Brigham and Women's Hospital and Harvard Medical School found that five had an excessive production of an antibody protein in blood plasma cells that in some cases precedes development of other diseases, such as multiple myeloma...

http://www.int.iol.co.za/index.php?set_id=1 & click_id=31 & art_id=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/308/30803.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/Noonan-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/m320en.pdf

Science and the Statistical Victim:

Modernizing Knowledge in Breast Implant Litigation

SAGE, Social Studies of Science, Vol. 32, No. 1, 37-69 (2002)

Sheila Jasanoff sheila_jasanoff@...

Using silicone gel breast implant litigation as a case study, this paper argues that the attempt to marry judicial concerns for individual justice with administrative concerns for speed, efficiency and economy has produced anomalous results. The testimony of the clinician and the victim has become less relevant as judicial remedies take account of injuries done to classes of plaintiffs. Subjective claims about the body are subordinated to statistical correlations between exposure and grouped complaints. At the same time, the transfer of fact-finding authority from juries to judges under new evidentiary rules has privileged the judiciary's lay knowledge and experience over that of the jury. While these transformations may hasten the processing of cases, the paper questions whether the courts can legitimately take on board the issues of risk and social justice in contemporary industrial societies...... http://sss.sagepub.com/cgi/content/abstract/32/1/37

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

Greenwood Want Details From FDA on Breast Implant Studies

Correspondence - The House Committee on Energy and Commerce - July 11, 2002

LETTER FROM - W.J. "" Tauzin

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

Dear Dr. Crawford,

On July 9, 2002, two saline breast implant manufacturers, Mentor Corporation and Inamed, presented studies at an FDA advisory committee hearing that showed more than a quarter of women who receive saline implants to increase the size of their breasts will undergo another breast operation within five years........

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

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

Breast Implant Settlement

The Associated Press - 1 september 2002

U.S. pharmaceutical maker Bristol-Myers Squibb Co. has reached an out of court settlement with a group of Australian women over faulty breast implants manufactured by the company, a court heard Tuesday....... http://www.fonendo.com/noticias/20/2002/09/1.shtml

Women victors over faulty implant maker

The Sydney Morning Herald - September 11 2002

By Robotham jrobotham@... and Fergus Shiel

Thousands of Australian women have received individual payments of up to $120,000 after suing the Dow Corning Corporation over faulty silicone breast implants.......

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

Woman attacks breast implant payout

The Sydney Morning Herald - September 25 2002

A New Zealand woman has attacked the size of the payout she received from a United States company for the suffering caused by their silicon gel breast implants. Kathy , from Timaru, is one of about six New Zealand women who received the Dow Corning silicone breast implants in Australia.... http://www.smh.com.au/articles/2002/09/25/1032734172554.html

2003

Breast implants - Debates of the European Parliament

13 february 2003

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

Prime time television Breast Implant commercials: ABC

CNN.com - Transcripts - August 5, 2004

SERWER: Yes. CAFFERTY: One other item here and then we'll toddle along. Prime time television commercials advertising breast implants coming to ABC this fall. Some outfit called Mentor Corporation scheduled to debut six prime time commercials during the program on ABC called "Extreme Makeover." The company says it wants to create a quote classy elegant ad... SERWER: Classy. CAFFERTY: ... targeting the working woman or mother. There is no word yet whether there will be any advisories about the potential complications that can arise from breast augmentation surgery or for that matter why its supposedly a good idea to get breast implants in the first place.

( SOURCE - http://edition.cnn.com/TRANSCRIPTS/0408/05/ltm.03.html )

- Breast implants may increase platinum levels

- Fears over 'harmful' platinum in breast implants

- More Platinum Found in Women With Implants

AP / Globe Staff , By Diedtra , dhenderson@...

26 august 2004

WASHINGTON - Researchers have found high concentrations of platinum in women who got silicone breast implants and in the children they bore and breast-fed afterward. The type of platinum found in the women's blood and urine was different than the traces of regular platinum not uncommon in people's bodies. It was a highly reactive platinum, used to help turn silicon oil into the honey-like gel that lends a more natural feel to a breast implant........................

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

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

http://www.tucsoncitizen.com/index.php?page=national & story_id=082604b3_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/messages/46343.html

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[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

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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 & _sort=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 & _sort=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.html

FDA panel backs breast implants from one maker

New York Times - 14 April 2005 - By Gardiner

GAITHERSBURG, Md., April 13 - Silicone breast implants made by a California company should be available to women who undergo cosmetic breast surgery, a federal advisory panel voted on Wednesday, rejecting arguments about serious health problems. The panel chairman called the 7-to-2 vote to approve an application by the company, the Mentor Corporation, unexpected. On Tuesday, the panel voted, 5 to 4, to reject a similar application from the Inamed Corporation......

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

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

No scientific consensus on silicone breast implants

Health Risk or a Woman's Choice?

USNews.com, By Querna healthbriefs@... - 25 april 2005

Both Carolyn Wolf and Michele Columbo came to the Food and Drug Administration's advisory panel meeting on breast implants last week with strong feelings about the availability of silicone implants....... http://www.usnews.com/usnews/health/articles/050425/25breast.htm

Breast implant maker accused of cover-up

Associated Press, May 23, 2005

WASHINGTON - Two former employees of a breast-implant manufacturer alleged the company covered up high rupture rates and workers were so fearful of bosses finding defective implant parts that they hid the parts in the ceiling. The allegations are contained in a 2003 lawsuit against the Mentor Corp.. http://www.yourlawyer.com/articles/read/9753

Whistleblowers "Implant Manufacturer engaged in Cover-Up"

May 25, 2005 , Newsinferno.com

Two former employees of Mentor Corp., a manufacturer of breast implants, have come forward with allegations that the company covered up evidence of high rupture rates and that workers would hide defective parts in the ceiling to avoid detection by their superiors. These former employees claim that senior executives in the company told them to destroy reports detailing high rupture rates and that packaging for the implants was sometimes infested with fleas. The actual rupture rates far exceeded those reported to authorities according to one of the whistleblowers. A criminal investigation of Mentor was closed in 2002 and recently the company won a recommendation from federal scientific advisors that it be permitted to resume sales of its implants under certain conditions.

( SOURCE - http://www.yourlawyer.com/articles/read/9807 )

Silicone suits crawl along

Thousands await money years after implant maker pledged $2.35 billion

Dallas Morning News, Texas, By Sherry son - sjacobson@...

28 May 2005

It's been 25 years since Dintino [statement of Dintino - FDA Panel Hearings - October 2003 - http://www.gyxe.com/breast-implant/7-625-statement-of-linda-dintino-fda-panel-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.html

Regarding Petitions to Block

FDA Approval of Silicone Gel Breast Implants

Public Citizen's Health Research Group - Statement of Sidney M. Wolfe, M.D.,

August 9, 2005

The fundamental questions are: (1) Are silicone gel breast implants safe, and (2) Have the companies done studies that provide reasonable assurance of safety as required by FDA regulations and guidances?.....

BREAST IMPLANT CHRONOLOGY .....

1988: Public Citizen files a petition to ban silicone gel breast implants....

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

1998: Public Citizen testimony before Instituteof Medicine(IOM)..

1999: IOM Recommendations..

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

FDA urged to hold off on approving silicone-gel implants

By Rita Rubin, USA TODAY - 10 August 2005

[ Health and Behavior Reporters - kthomas@... ]

A coalition of health advocacy groups urged the Food and Drug Administration on Tuesday to refrain from approving silicone-gel breast implants until the manufacturer provides long-term data about the devices' safety.. http://www.usatoday.com/news/health/2005-08-09-breast-implants-fda_x.htm

Tits for Tat

Bush's FDA moves forward on approving silicone breast implants but still stalls on emergency contraception

by Weinstein - 15 August 2005

When a federal Food and Drug Administration advisory panel recommended the approval of one company's silicone gel breast implants this spring—even though some women had testified that the gel oozed out of their eyes, ears, and nipples—one word kept coming up over and over again: choice. A panelist told The New York Times that it was important to give women a choice of implants......

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

Mother tells how hospital removed Healthy breast

News Scotsman - JAMES HALL - 5 Sep 2005

A MOTHER has revealed how she had a healthy breast removed after being wrongly diagnosed with cancer. Marjory , 52, was told by doctors - over the phone - that she had a rare and aggressive form of cancer and that she needed a mastectomy. Less than a month later, doctors at Raigmore Hospital, Inverness, admitted they had been looking at another patient's tissue sample and made a mistake. It took nearly two years for Highland Acute Hospitals NHS Trust to offer Mrs just £44,000 compensation.. http://news.scotsman.com/scotland.cfm?id=1891152005

FDA endorses 2d firm on Silicone Implant sales

Boston Globe, Massachusetts. 22 September 2005

By Diedtra , Globe Staff - dhenderson@...

The Food and Drug Administration yesterday told a second manufacturer it is willing to approve wider sales of its silicone gel-filled breast implants.... http://www.boston.com/business/globe/articles/2005/09/22/fda_endorses_2d_firm_on_silicone_implant_sales/

MPs call for removal of

Health Canada's breast-implant panel members

Eggertson eggerts@... with files from Sally Murray, CMAJ

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

Opposition MPs are calling on Health Canada to remove members of an expert advisory panel on breast implants, or to suspend the panel's work, because at least 3 members have ties to manufacturers of the medical devices.... http://www.cmaj.ca/cgi/content/full/173/10/1144

Reprieve For Breast Implants

Their safety is unproved, but it's tough to ban something already used by 2 million U.S. women - TIME, By Michale D. Lemonick - Nov 11, 2005

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

Zonyl Packaging Whistle-blower:

DuPont Knows Food-Packaging Risk

Jack Kaskey jkaskey@... Bloomberg News, 17 nov 2005

DuPont Co., the third-largest U.S. chemical producer, is tainting candy, butter, popcorn and baked goods with a potentially cancer-causing chemical that seeps out of grease-resistant packaging, a former company scientist said yesterday...................

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

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

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

November 22, 2005

BETHESDA, Md.- A new type of breast implant already available in other countries may soon be making its way to the United States.... http://www.nbcsandiego.com/health/5381622/detail.html

Want breast implants? Do research first

Knight Ridder Newspapers, By Garloch kgarloch@...

Dec. 02, 2005

Naked from the waist up, Sharon Eller endured the medical exam by avoiding the eyes of two men staring at her breasts. Dr. J.P. Riou backed up for a better look. He tipped his head toward Sharon's husband, Maurice, and pointed out that her right breast hung lower than her left. Women's breasts rarely match, the plastic surgeon said. But he could fix that................

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

Breast reconstruction with implants:

no survival disadvantage

Nature Clinical Practice Oncology (2005) 2, 64doi: 10.1038 / ncponc 0089

Responding to concerns about the possible adverse effects of breast implants after mastectomy, Le et al. have recently published the results of their large, population-based study. Breast implants did not appear to confer any survival disadvantage; in fact, the long-term risk of breast cancer mortality was lower in women with implants than in those without... [Full text available with e.g. Personal subscription ] http://www.nature.com/ncponc/journal/v2/n2/full/ncponc0089.html

Blowing the whistle on Mentor

PUBLIC RADIO, 5 December 2005

Silicone breast implants are stirring up controversy again. An ex-employee of implant maker Mentor claims the company misrepresented safety data and chose not to fix a problem with their implants. From the Health Desk at WGBH, Helen Palmer reports - LISTEN to this story -

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