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FDA Urged to Hold Off on Approving Silicone-Gel Implants

Posted on: Wednesday, 10 August 2005, 06:00 CDT

WASHINGTON -- A coalition of health advocacy groups urged the Food and Drug Administration on Tuesday to refrain from approving silicone-gel breast implants until the manufacturer provides long-term data about the devices' safety.

"We can't risk another Dalkon shield," said Cindy Pearson, executive director of the National Women's Health Network. The Dalkon shield intrauterine contraceptive device, or IUD, came on the U.S. market in 1971 and was pulled in 1974 amid claims that it caused pelvic inflammatory disease, which can leave women infertile.

The groups also called on Congress to investigate what they described as the FDA's lowered safety standards for silicone-gel implants. Since 1992, the implants have been available to U.S. women only in clinical trials, and then only to those who have had a mastectomy, were born with a deformity or needed to replace other implants.

An FDA advisory panel voted 7-2 in April to recommend approving Mentor Corp.'s application to market silicone-gel implants if certain conditions, such as collecting long-term safety data, were met. At the meeting, the company provided only three years' worth of information.

"We know that implants do break in the body," Diana Zuckerman, head of the National Research Center for Women & Families, said at the advocates' news conference. "We need to know what happens to women when that silicone is leaking in their body."

On July 28, the FDA sent Mentor a letter stating that its silicone-gel implants would be approved if certain questions were resolved.

"(FDA Commissioner) Lester Crawford is a veterinarian, and now he's treating women like dogs," said National Organization for Women president Kim Gandy.

The FDA wouldn't reveal the contents of the letter. Gandy says her group has submitted a Freedom of Information Act request seeking details about the agency's conditions for approval. NOW also is seeking documents related to a now-closed criminal investigation of Mentor related to allegations of falsified data about its silicone-gel implants. No charges were filed.

FDA spokeswoman Julie Zawisza said Tuesday that the agency is prohibited by law from releasing any information about products that are under review. "We did issue this approvable letter, but we can't discuss what's in the letter. Only the company can do that."

On the day the FDA issued the approvable letter, Mentor CEO Josh Levine would say only that the agency's conditions were similar to the advisory committee's.

Levine called the activist groups' allegations unfounded. "The FDA and its advisory panel rigorously and objectively reviewed Mentor's data and related science," he said in a statement Tuesday. "We remain confident this scientific process will not be complicated by old accusations from parties with agendas that go well beyond the safety and efficacy of these products."

Neither the FDA nor Levine would say when a final decision on Mentor's application is expected.

Source: USA TODAY

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