Put Science First at the FDA!

Starting Monday, April 11, an FDA Advisory Committee will once again consider approval of silicone breast implants for general use. The Food and Drug Administration (FDA) denied the breast implant manufacturer's applications in 2004 because they failed to provide important safety evidence, including more information about breakage and the long-term health risks of leaking silicone into the human body. As long as there still is no adequate proof that silicone implants are safe for long-term use, the manufacturers' applications must again be denied to protect women's health.

But the breast implant makers are relentless and the FDA may cave in this time.

What we do know about Silicone implants:
  • Mammograms will miss about 67% more breast cancer tumors in women who have silicone breast implants than in women without, according to a Journal of the American Medical Association article.
  • All implants will rupture eventually and have to be removed or replaced, most within 10 to 12 years.
  • Women who have silicone breast implants for at least seven years are twice as likely to die from brain cancer, three times as likely to die from lung cancer, and four times as likely to commit suicide compared to other plastic surgery patients, according to the National Cancer Institute.
MAKE SURE THAT THE FDA IS GUIDED BY SCIENCE, NOT POLITICS

Sign this petition to tell Members of Congress, FDA senior officials, and the White House to PUT SCIENCE AHEAD OF POLITICS and REJECT approval of silicone implants for general use until adequate research and long-term data are available. Time is Running Out!
Dear Member, FDA, and Mr. President,

Next week an FDA Advisory Committee will once again consider approval of silicone breast implants for general use. The Food and Drug Administration (FDA) denied the breast implant manufacturer's applications in 2004 because they failed to provide important safety evidence, including more information about breakage and the long-term health risks of leaking silicone into the human body. As long as there still is no adequate proof that silicone implants are safe for long-term use, the manufacturers' applications must again be denied to protect women's health.

What we do know about Silicone implants:

1. Mammograms will miss about 67% more breast cancer tumors in women who have silicone breast implants than in women without, according to a Journal of the American Medical Association article.

2. All implants will rupture eventually and have to be removed or replaced, most within 10 to 12 years.

3. Women who have silicone breast implants for at least seven years are twice as likely to die from brain cancer, three times as likely to die from lung cancer, and four times as likely to commit suicide compared to other plastic surgery patients, according to the National Cancer Institute.

But the breast implant makers are relentless and the FDA may cave in this time.

In early March, breast implant makers distributed a memo through FDA staff with the clear intention of persuading senior FDA officials, including Acting Commissioner Lester Crawford, to approve breast implants for general use. The industry memo distorts the facts all in the name of promoting women's "choice."

PLEASE MAKE SURE THAT THE FDA IS GUIDED BY SCIENCE, NOT POLITICS

Millions of women depend on the FDA's approval as an accurate and reliable standard of safety. For the public, 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.

The fact is THERE IS NO CHOICE WITHOUT A SAFE CHOICE.


I URGE YOU TO PUT SCIENCE AHEAD OF POLITICS AND REJECT APPROVAL OF SILICONE IMPLANTS FOR GENERAL USE UNTIL ADEQUATE RESEARCH AND LONG-TERM DATA ARE AVAILABLE.

Sincerely,
[Your Name]
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