FDA Panel Opposes Silicone Gel Implants

A Food and Drug Administration expert panel voted narrowly yesterday against allowing silicone gel breast implants back on the market for general use, saying the available scientific data are too scant to provide assurance that newer versions would be safe.

After two days of emotional and technical testimony, the panel decided 5 to 4 not to recommend that the agency overturn its 1992 partial ban on the implants.

"This hearing was premature," panel member Amy Newburger, a suburban New York dermatologist, said after the vote. "I don't feel secure about the safety issue. I don't see how we can get or give adequate informed consent for our patients based on the data we've seen."

Inamed Corp. sought the new advisory meeting a year after the agency rejected its earlier application and presented one additional year of safety data. While panel members complimented the company on its research, they concluded there was not enough new information on key issues, including why some implants leak, the effect of released silicone and the long-term risks of intact implants.

Company officials appeared stunned by the decision. "We believe in our data and think it was strong," said Dan Cohen, Inamed's vice president of global government and corporate affairs. "I was surprised. . . . The panel's decision was disappointing."

Cohen said the company will continue developing silicone gel implants -- which are still available to women after mastectomies and to some in clinical trials -- and expects to be back before the agency in the future.

The FDA usually follows the recommendations of its advisory panels, but not always. An earlier panel voted 9 to 6 for Inamed's silicone implants in October 2003, but the FDA turned down the application, saying it left unanswered many of the same questions that troubled the panel majority yesterday. After yesterday's vote, Cohen held out the possibility that the agency could again overrule the advisory panel, this time to the company's benefit.

More than 320,000 U.S. women received implants last year, about 260,000 for cosmetic reasons and 60,000 after a mastectomy, and the number has been growing by more than 10 percent a year. Most are the less popular saline-filled implants, which many women believe do not look or feel as good as silicone gel models.

Many plastic surgeons and their patients were among the more than 150 people who testified for and against the silicone gel implants over two days of hearings. They said the devices are safe and women deserve the opportunity to make an informed choice about whether to use them. Dozens of women testified about terrible complications from their implants, often in graphic detail.

Using another full year of data on rupture rates and studies of why the failures occur -- as well as data from abroad, where silicone gel implants are in wide use -- Inamed argued that the number of failures was low and that many were caused by errors by the surgeons who implanted them.

Company officials also said there was no indication that women with gel implants were more prone to connective-tissue disease than other women, a fear that contributed to the 1992 decision to take the implants off the market. Many women have complained of fatigue and sometimes severe joint and muscle problems after getting implants.

Cynthia Pearson, executive director of the National Women's Health Network, cited the complaints in urging the panel to reject the application. "What women want to know is that if I'm healthy when this starts, what's the chance the implant will cause me trouble and how will I feel in the future?" she said.