Fwd: Take Action Now: Tell Congress to Sign Letter Urging the FDA to Reject Silicone Implants

[Guest guest]

Note: forwarded message attached.

Take Action Now

Take Action Now: Tell Congress to Sign Letter Urging the FDA to Reject Silicone Implants

MEMBERS OF CONRESS SHOULD TELL FDA TO SUPPORT FDA SCIENTISTS

Take Action!

FDA ACTING COMMISSIONER CRAWFORD SHOULD REJECT APPROVAL OF SILICONE BREAST IMPLANTS

FDA Acting Commissioner Crawford has a decision to make. He can either support his own FDA scientists by rejecting silicone breast implants reentrance into the general market or he can support industry and allow these devices back on the market.

The recent split decision on silicone breast implants by the FDA’s General and Plastic Surgery Devices Panel raises serious public health concerns. While the Advisory Panel voted against recommending approval for Inamed’s PMA but recommended approval for Mentor’s PMA, FDA scientists found that BOTH companies failed to sufficiently respond to questions regarding the long-term safety of their products.

FDA scientists have presented clear and compelling evidence that silicone breast implants have not been proven safe. The FDA concluded that the Inamed’s Core Study data “are of limited value” and that the published articles referred to by Inamed “do not completely address all the health consequences of

rupture.” FDA also concluded that the Mentor Core Study data “are of limited value” in assessing health consequences and that the published articles referred to by Mentor “do not completely address all the health consequences of rupture, and the literature is not specific to Mentor implants.” In addition, the Mentor Corporation has not been a responsible corporate citizen. The company has been the subject of the longest criminal investigation in FDA history, for which no information has ever been released publicly.

MAKE SURE THAT THE FDA IS GUIDED BY SCIENCE, NOT INDUSTRY PRESSURE. 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.

TELL MEMBERS OF CONGRESS TO SIGN ON TO THE LETTER ASKING COMMISSIONER CRAWFORD TO SUPPORT THE

FINDINGS OF FDA SCIENTISTS. COMMISSIONER CRAWFORD SHOULD REJECT APPROVAL OF SILICONE IMPLANTS FOR GENERAL USE UNTIL ADEQUATE RESEARCH AND LONG-TERM DATA ARE AVAILABLE.

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