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Action Needed
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Ask the FDA to Delay Approval of Silicone Breast Implants
Until Safety is Proved
Action Needed:
Please urge the Food and Drug Administration (FDA) to delay approval of
silicone gel-filled breast implants until long-term studies prove that
the implants are safe. Silicone implants were removed from the market
in 1992 when it was revealed that they have a high rupture rate and that women had
reported suffering from a multitude of symptoms. Only saline (salt water)
implants are available for general use.
An advisory committee to the FDA will soon review an application from
implant manufacturers to re-introduce the silicone gel-filled devices, based on only two
or three years of manufacturers' clinical trials, even though recent studies indicate
that most serious problems with breast implants begin to appear after
about seven to 10 years. Tell the FDA that two or three years of clinical trials is not enough!
Based on reports over the years, thousands of women with silicone breast implants have become ill; some have died or committed suicide when they could not find relief from their pain and disfigurement. Last year alone, almost 300,000 women received breast implants for augmentation or reconstruction and the numbers continue to grow, but few women are aware of the risks.
Please take action now:
- Send an email message to the FDA. Feel free to change the text to reflect your own experiences
and opinions.
- If you are a breast implant patient (or know someone)
who has been experiencing problems, file a statement with the
FDA through their adverse event
reporting system and also with the FDA
Medwatch program. (Fill out the Medwatch Online Voluntary
Report Form 3500.) Alternately, contact the Food and Drug Administration,
Center for Devices and Radiological Health, 5800 Fishers Lane, Rockville,
Md. 20957 or call 1-888-463-6322. Copy the National Organization for
Women (NOW) with your statement by e-mailing it to govtrel@now.org.
Background:
At a July 21 press conference, the National Organization for Women released a summary of the findings of a scientific symposium, held on May 8, where a panel of researchers reported on their immunological, bio-materials and clinical studies. Among their conclusions:
- Past research has not adequately addressed the issue of long-term
safety of silicone gel-filled breast implants;
- Potential implications of long-term exposure to migrated silicone
gel following gel-bleed or a ruptured breast implant device have not
been adequately studied;
- New research suggests that silicone may act as an adjuvant ?
a substance that nonspecifically enhances the immune response to an
antigen;
- Clinical trials must be implemented to capture long-term safety data, to evaluate health implications of the silicone gel in the lymphatic system and surrounding tissues; and
- The high prevalence of so-called "local complications" such as hard capsules, chronic inflammation, frequent re-operations and disfigurement has not been adequately discussed with women in informed consent.
>From this discussion and other data, we know that virtually all breast implants
leak and eventually rupture or disintegrate, usually within about 15 years.
When a silicone implant ruptures, silicone gel can migrate throughout
the body and, as recent data suggest, cause the immune system to respond
with an array of symptoms, including joint soreness, nausea, headaches,
fatigue, localized pain, local infections, cognitive problems and other
difficulties. Women with silicone implants have reported developing
serious diseases such as rheumatoid arthritis, lupus, Sjogren's syndrome,
scleroderma, Raynaud's syndrome and fibromylagia.
Problems begin to surface, on average, between seven and 10 years after implantation. Yet the FDA is poised to review an application to re-introduce silicone implants onto the general market based on only two or three years of clinical data from the manufacturer. Moreover, the FDA is only required to look at the information presented by the manufacturer—hardly an unbiased source—and is allowed to ignore other pertinent data!
NOW President Kim Gandy noted that research show one in four
women get additional surgery within five years after implantation, often
due to painful and debilitating complications. In commenting
on the researchers' findings, Gandy said that the panel of leading researchers
at the NOW symposium agreed that "recent research has raised additional
questions, and that we know only a few things for sure: breast implants
have a very high product failure rate, they cause severe and painful local
problems, and that we don't know their long-term health effects."
Gandy went on to emphasize that the Institute of Medicine's 1999 review of
studies on breast implants "was widely misinterpreted as an exoneration
of the devices ... the IOM acknowledged product failure and grotesque
local complication problems." The Institute made clear that many of the
existing studies on long-term health effects of silicone breast implants
were flawed and that additional research was needed.
NOW was joined at the press conference by Sidney M. Wolfe, M.D., Director of the Public Citizens' Health Research Project, Dr. Diana Zuckerman, President of the National Center for Policy Research (CPR) for Women and Families, and Cynthia Pearson, Executive Director of the National Women's Health Network.
More information on breast implants, and silicone-gel implants in particular, can be found at the Implant Information Project, a site sponsored by the National Center for Policy Research (CPR) for Women & Families as well as at the website for Command Trust, an information resource for women about problems with breast implants.
Again, please urge the FDA to delay approval of
silicone gel-filled breast implants until long-term studies prove that
the implants are safe. Two or three years of clinical trials is not enough!
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