NOW Urges FDA to Reject Risky Silicone Gel-Filled Breast Implant Applications

April 6, 2005

"Women's lives and health are once again in the hands of politicians and political appointees who are determined to hand drug companies a huge payout," said NOW President Kim Gandy. "It is absolutely critical that the Food and Drug Administration (FDA) demand long-term safety data, conduct a thorough review of all data submitted from silicone gel-filled breast implant makers, and listen to the advice of agency scientists who are advocating against any approval of these devices."

On April 11, 2005, Gandy will testify before an FDA Advisory Panel about the health dangers of silicone gel-filled breast implants. The Panel is considering whether to recommend that the FDA approve silicone gel-filled breast implants made by Inamed Corporation and Mentor Corporation. In January 2004, the FDA decided to retain restrictions on the availability of these implants because the data submitted by the manufacturers was insufficient to provide a reasonable assurance of safety. Recent disclosures about the FDA's vulnerability to influence from drug manufacturers pressuring them to rush poorly tested medication to market are cause for alarm, and it appears that the same thing is happening in this case.

"The FDA will put hundreds of thousands of women at risk for potentially devastating long-term consequences and high rates of complications if they allow politics and profits to trump science," said Gandy. "Tens of thousands of individuals may have suffered a stroke or heart attack and died after using popular arthritis drugs that were railroaded through the FDA approval process. We must stop this cycle of negligent behavior." Silicone gel-filled breast implants were taken off the market in 1992 after complaints emerged from patients about ruptures, leakages and a variety of illnesses. Since then the courts have recognized their harm to women's health in a $2.35 billion class action settlement - one of the largest in U.S. history.

The risks facing women with silicone implants are real and serious. Concerns about silicone leakage, increased risk of death from suicide, brain cancer and lung cancer have been documented by clinical research and recognized by the FDA. Yet both breast implant makers and plastic surgeons stand to reap enormous profits should silicone gel-filled implants be approved by FDA for general use.

"A decision in favor of silicone gel implants would severely compromise the FDA's scientific integrity and demonstrate their utter disregard for women's health," said Gandy. "The FDA's decision will either be a wake-up call to manufacturers for better research and safer products or a rubber stamp that will harm generations of women to come."

CONTACT: JENNY THALHEIMER, 202-628-8669 x 116