ACTION ALERT: Please join us in writing the FDA regarding dangerous breast impla

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Action Alert

Stop FDA Folly: Dr. Crawford Should Not Approve Silicone Implants

for General Use

April 15, 2005

FDA ADVISORS PUT PROFITS OVER PUBLIC HEALTH

Split Decision by Implant Panel Leaves FDA Chief to Choose Between

Industry Profits and Women's Safety

On April 12-13, the Food and Drug Administration's Advisory Panel on

silicone gel-filled breast implants recommended keeping the ban on

one company's product, while allowing a similar product to be

marketed widely. The FDA's own scientists had found that both

companies failed to sufficiently respond to questions regarding the

safety of their devices, but the panel ignored the scientific

evidence regarding one of those companies.

TAKE ACTION NOW

Tell Acting Commissioner Dr. Lester Crawford to support the FDA's

own scientists and public health professionals. He must uphold the

integrity of the scientific process, and put women's health above

political gain.

BACKGROUND:

Millions of women depend on the FDA to set an unbiased, reasonable

standard of safety. For the public, the FDA stamp of approval

implies that there is no danger. But without long-term research on

silicone gel implants, it is not possible to draw such a conclusion,

and indeed there is much evidence to the contrary.

Indeed, the FDA's credibility is being undermined by politically

motivated decisions. There is a growing list of examples where the

FDA's own scientists have been silenced or overruled:

antidepressants, Vioxx, Bextra, heart defibrillators and Plan B

emergency contraception. When FDA scientists sound the alarm it is

more like a silent alarm - very silent..

FDA scientists point out that implants, like cars and hearts, are

more likely to fail as they age, and they estimate that up to 93% of

implants will rupture within 10 years. The professional staff found

that it was not possible to predict with any confidence what the

rupture rate would be, and without long-term information on breakage

and leakage we don't know the long-term health risks of implant

failure.

Based on the scientific evidence from the industry's own data, there

is no responsible choice but to reject these applications.

TAKE ACTION NOW

Urge Dr. Crawford to reject both applications in order to:

Restore credibility to the FDA, and

Protect women from health risks posed by silicone implants.

Tell him that for women, THERE IS NO CHOICE WITHOUT A SAFE CHOICE.

Make sure that the FDA is guided by science, not politics.

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Please distribute to all those who are concerned about women's

health.

www.BreastImplantAwareness.org