Fw: PRESS RELEASE: FDA Study Links Silicone Migration to Several Diseases

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From: " ilena rose " <ilena@...>

Sent: Wednesday, May 02, 2001 1:08 PM

Subject: PRESS RELEASE: FDA Study Links Silicone Migration to Several

Diseases

>

> NEWS RELEASE National Women's Health Network

> FOR IMMEDIATE RELEASE

> >

> May 1, 2001 FOR MORE INFORMATION

>

> Amy Allina: 202 347-1140

>

> Ruptured Silicone Breast Implants Linked to Pain, Disease

>

> FDA Study Links Silicone Migration to Several Diseases

>

> WASHINGTON, DC - Ruptured and leaking silicone breast implants were

> significantly linked to painful connective-tissue and soft-tissue diseases

> such as fibromyalgia, pulmonary fibrosis, dermatomyositis, and other

> debilitating diseases in a new study by a team of scientists from the Food

> and Drug Administration (FDA), and medical schools at Duke University,

> University of land, and University of California at San Diego. The

> study was published in the May issue of the Journal of Rheumatology. The

> study is the first to systematically evaluate the health of women with

> ruptured breast implants. Women with ruptured implants could potentially

> be at increased risk of health problems compared to other implant

> patients, because they have greater exposure to silicone, and because

> silicone sometimes migrates outside the breast area to other parts of the

> body, such as arms and lungs.

>

> The study compared three groups: 1) women with silicone gel implants

that

> had not broken; 2) women with silicone implants that had ruptured with

> silicone gel spreading beyond the scar tissue surrounding the breast

> implants, and 3) women whose implants had ruptured but the silicone had

not

> spread beyond the scar tissue surrounding the implants. The results

> indicated that the women who had silicone that had migrated outside the

> scar tissue surrounding the breast implant were significantly more likely

> to report having been diagnosed with fibromyalgia (a painful soft-tissue

> disease) and other serious connective-tissue diseases and related

> conditions such as dermatomyositis, polymyositis, Hashimoto's

thyroiditis,

> pulmonary fibrosis, eosinophilic fascitis, and polymyalgia " This study

is

> the first of its kind -- the first study to examine the health of women

> with ruptured, badly leaking silicone gel implants. It's hard to believe

> that more than 35 years after the first silicone breast implants were

> sold, we have the first published study showing the effects of silicone

> implant rupture. The study supports what many women with implants have

> described -- a link between ruptured implants and debilitating pain and

> diseases " concludes Pearson, Executive Director of the National

> Women's Health Network.

>

> The study evaluated 344 women with silicone gel implants who had not

sought

> to have the implants removed, and who were contacted from a list of all

> patients from two medical practices. They were selected from a sample of

> 907 augmentation patients for a study designed to determine the percent

of

> implants that are ruptured in the population of women who have not sought

> treatment for problems with their implants; 70 women who had their

implants

> removed were excluded from the original sample of women, as were women

with

> saline implants. Eighty-one percent of the women who were invited to

> participate in the study accepted.

>

> The women were asked about their health, answering questions about five

> symptoms (such as rashes and joint pain) and seven physician-diagnosed

> connective tissue diseases and related conditions. After the interview,

> they were asked to undergo Magnetic Resonance Imaging (MRI) to determine

> whether their implants were ruptured.

>

> A majority of the 344 women had at least one ruptured implant, although

> the women appeared to be unaware of that fact. In addition, 21 percent

of

> the women had silicone that had migrated outside the capsule of scar

> tissue that surrounds at least one of their breast implants.

>

> " This is a well-designed study with the surprising finding that many women

> with breast implants who are ill are not seeking medical help or advice,

> even in situations where leaking silicone gel sometimes causes rather

> obvious cosmetic symptoms " Pearson points out. The National

> Women's Health Network and the National Center for Policy Research (CPR)

> for Women & Families are urging the FDA to immediately update its

consumer

> materials and provide information to physicians in a " Dear Doctor " letter

> to inform them of the results of this important study. " Women and their

> physicians need to be aware that silicone can spread from ruptured

> implants, and potentially increase the risk of serious diseases " concludes

> Dr. Zuckerman, Executive Director of CPR for Women & Families.

>

> The study results will be published in the first week in May, the same

time

> as two recently reported major studies, which indicate that women who have

> breast implants are more likely to die from brain tumors, lung cancer,

> other respiratory diseases, and suicide compared to other plastic surgery

> patients.

>

> Since 1992, the FDA has restricted the availability of silicone gel

breast

> implants to women with mastectomies, breast deformities, and for the

> replacement of broken gel implants. However, the FDA recently increased

> the availability of silicone breast implants for augmentation patients.

>

> The National Women's Health Network is the only national non-profit public

> interest membership organization dedicated exclusively to women's health.

>

> NWHN does not accept financial support from pharmaceutical companies,

> tobacco companies, or medical device manufacturers. ##

>

>