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October 21, 2003  
  We the undersigned, endorse the following petition:
FDA Decision Could Endanger Women!
Target: US Senators
Sponsor: National Women's Health Network.r>
pen nibSIGNATURES.11,880

pen nibGOAL: 8,500

pen nibDEADLINE: Ongoing ...

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.

    .....     See full petition below.td>
      

    The FDA panel voted to lift the ban on silicone implants. This Petition is now closed. Thank you for your support.
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    .>MOST RECENT 25 of 11,880 SIGNATURES
    Number Date Name Why do you oppose approval of Silicone Implants? Please relate any experiences with Silicone Implants
    11,880  8:13 am PDT, Oct 21 Susan A. Taylor I have had a double mastectomy. Why would anyone in their right mind want to jeopardize their health just to enlarge their breasts?  
    11,879  8:05 am PDT, Oct 21 Anonymous Certainly if emergency birth control can be held for study year after year, these implants already known to be severely harmful to women and without any medical benefit whatsoever should be subjected to the most rigorous study by impartial parties before being approved by the FDA. The FDA is become almost irrelevant in its irresponsible catering to corporate interests.  
    11,878  7:36 am PDT, Oct 21 Amy Robinson It disturbs me that the FDA would push approval for implants that are purely for profit to the companies that make them, while new medications and procedures that can actually save lives are not given the same level of importance.  
    11,877  7:35 am PDT, Oct 21 Lynette Bilello    
    11,876  6:08 am PDT, Oct 21 Marsha Perry Alot more testing needs to be done on these before they release them for public use.  
    11,875  6:03 am PDT, Oct 21 Molly Myers    
    11,874  5:35 am PDT, Oct 21 Carla Smith There was NEVER enough testing done in the beginning to prove the safety of the implants. Many women have suffered and some have died. Until the FDA can assure EVERYONE that the implants WILL NOT LEAK they should not be used. Women are TEST ANIMALS! The doctors who implanted the implants years ago didn't care about the health of their patients only the money that they made! A study of at least 10 years that proves that the implants don't leak would be a good place to start. Until then BAN SILICONE IMPLANTS!!!  
    11,873  5:14 am PDT, Oct 21 rosemary Sanchez With all the problems they have presented in the past i believe further study is warranted before approval.  
    11,872  3:50 am PDT, Oct 21 Madeline Kramer There has not been enough scientific evidence that these work. Why should we be used to test things? My sister-in law had to have her's removed when they started leaking.
    11,871  2:29 am PDT, Oct 21 Wanda E Larose    
    11,870  1:17 am PDT, Oct 21 Anonymous Insufficient data/reuslts to prove that silicone does NOT harm our body, and we're talking about long-term effects or those that can only be seen years later. and all that in the name if beauty,,, NA
    11,869  12:13 am PDT, Oct 21 reini jensen    
    11,868  11:42 pm PDT, Oct 20 Charlene L. Lawrence I think that more testing needs to be done to ensure safety.  
    11,867  11:27 pm PDT, Oct 20 Anonymous I believe these implants are frivolous and dangerous to the health of the women who have and may in the future use them. I have never had and would never have any sort of implant for vanity. I have friends who have and the results have been detrimental to their overall well-being.
    11,866  10:24 pm PDT, Oct 20 J.J. Van Name The known and unknown medical dangers it presents to the body. Sister has them and a friend...both had problems with them.
    11,865  10:11 pm PDT, Oct 20 Anonymous    
    11,864  9:27 pm PDT, Oct 20 Sharon N. Hatfield Further testing needed to ensure the product is safe.  
    11,863  9:03 pm PDT, Oct 20 Anonymous    
    11,862  8:23 pm PDT, Oct 20 Lauren Graham We have already seen the effects of silicone implants, and with the hurried approval of these new versions, it is clear that women's health is unimportant, when pitted against corporate profits.  
    11,861  8:23 pm PDT, Oct 20 Anonymous Putting any thing unnatural into our bodies is not good. Look at all the side affects silicone implants have. As woman we have been taught to believe that bigger breast are more attractive to who- men and at what cost to our bodies? NO NO NO to FDA saying these silicone implants are safe. That is a lie.  
    11,860  7:46 pm PDT, Oct 20 Linea Johnston    
    11,859  7:39 pm PDT, Oct 20 Erika Gomez    
    11,858  7:37 pm PDT, Oct 20 Tressie Conway Testing has not been run for long enough to prove that they are safe. Previous problems with the implants were not detected until 6-7 years after initial implant. Testing for 2-3 years is not sufficient to warrant FDA approval.  
    11,857  7:16 pm PDT, Oct 20 Bryony Heise    
    11,856  6:25 pm PDT, Oct 20 Anonymous    

    .>FDA Decision Could Endanger Women!
    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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