FDA Endangers Women's Health With Silicone Breast Implant Decision

July 28, 2005

Today, the Food and Drug Administration (FDA) issued an approvable letter to Mentor Corporation, a manufacturer of silicone gel-filled breast implants, outlining specific conditions which Mentor must satisfy in order to receive FDA approval to widely market the dangerous implants — even though most experts acknowledge that the agency has no way to enforce the conditions.

"Women will risk a lifetime of grave complications from faulty breast implants because the Bush administration values short-term profits over women's long-term health," said NOW President Kim Gandy. "Only two weeks after Senators Patty Murray (D-Wash.) and Hillary Rodham Clinton (D-N.Y.) withdrew their hold on his confirmation, Bush-appointed FDA Commissioner Lester Crawford began his tenure by rewarding a company that has been accused by former employees of falsifying and withholding data about these implants."

According to The New York Times, a former Mentor product manager testified under oath that "top executives instructed him to destroy reports detailing the high rupture rates and poor quality of some types of implants" and another manager accused Mentor of dramatically underreporting failure rates of their implants.

"The FDA is not being coy about its political agenda," Gandy said. "The testimony of women who suffered from silicone-gel leakage and migration to other organs, painful capsular contraction and disfigurement, and increased risk of death from suicide, brain cancer and lung cancer — all which have been documented by clinical research and recognized by FDA staff — apparently don't offset the lobbying campaign directed at political appointees like Commissioner Crawford by their corporate supporters."

"The only winners here are the manufacturers and plastic surgeons who stand to reap enormous profits if these implants are finally approved by FDA for general use," Gandy said. "What happened to the FDA that once protected women from the cruelty of faulty medical devices, dangerous drugs and the greed of corporate interests?"

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