FDA Decision Could Endanger Women!

In just a few weeks, the FDA will consider approval of a new silicone breast implant. In 1992 silicone implants were pulled from the market because of MAJOR safety concerns many of which do not show up until 7-10 years after implantation. Still, after only a couple of years of research this new implant from INAMED is likely to be approved.

FDA Approval would be IRRESPONSIBLE: Millions of women depend on the FDA's approval as an accurate and reliable standard of safety. For many women, the FDA stamp of approval implies that there is no danger. Without long-term research on these new implants it is not possible to draw such a conclusion.
What we do know about Silicone implants:
  • Silicone is KNOWN to travel away from the breast to internal organs, and joints.
  • Women with silicone implants are three times more likely to report that they had fibromyalgia syndrome-- characterized by widespread pain, fatigue and sleep disturbance.
  • A National Cancer Institute study found that silicone implants increased the risk of cancer. The incidence of leukemia, stomach, cervical, vulva and brain cancers were twice as high for women with implants.
  • Previous studies and experience should URGE CAUTION! Approval of silicone implants would reject caution, misleading women to believe that such implants are safe, only because they haven't YET been proven unsafe.

    Women are not guinea pigs! SIGN NOW and urge the FDA to reject approval of INAMED's implants until FURTHER research and long term data is available.


    Dear FDA Commissioner Mark McClellan

    I am writing to express my concern about the new Inamed silicone gel breast implant that the FDA is considering approving. I am extremely concerned about the safety and effectiveness of this new silicone implant. Women have had serious health problem with silicone gel implants in the past. And many of the problems that women have had with silicone implants do not appear until six, seven or even more years after implantation. Finally, the long-term health effects of silicone gel in the body have not been adequately studied.

    It is my understanding that Inamed will not be required to provide long-term safety data on this new implant. Silicone gel breast implants were pulled from the market in 1992 due to a lack of long-term safety data, and we still do not have that much needed information. Why rush to approve a device that may pose serious health risks without long-term safety data.

    I urge the FDA to require Inamed or any company seeking approval of a silicone gel breast implant to conduct studies on the long-term health effects of any new silicone gel breast implants before approving them. So many women have been hurt by silicone gel implants in the past. The FDA has the power to act now to prevent a new generation of women from experiencing the same harm.

    Signed,
    The Undersigned

    cc: David Feigal, Director Center for Devices and Radiological Health, David Feigal
    cc: Susan Wood, Director Office of Women's Health Susan Wood
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