FDA Revisits Silicone-Gel Implant Controversy

A federal advisory committee will soon recommend if silicone gel-filled breast implants should return to the U.S. market, 13 years after they were blocked for all uses except a few procedures such as reconstructive surgery for women who have undergone mastectomies.

For three days starting April 11, an advisory panel of the Food and Drug Administration will review product applications from Mentor (MNT) and Inamed(IMDC). Analysts say a victory for one at the expense of the other would provide a significant boost to the winner in the cosmetic surgery market.

But there's much more to silicone implants than discussions of sales and market share. One big question: How will the FDA react in a climate affected by such controversies as Merck's(MRK) withdrawing of the arthritis drug Vioxx or the use of antidepressants among adolescents that led to the FDA's ordering the most strict warning labels on these drugs?

As befits the passions surrounding silicone implants, the first day of hearings will be devoted solely to comments from the public.

"Don't let the silicone implant industry mislead Congress and the FDA into approving silicone implants for general use," says the National Organization for Women, in a recent message posted on its Web site. "They are simply too risky."

NOW and the consumer group Public Citizen have vigorously opposed silicone implants in the past via petitions and testimony to the FDA. "The risks facing women with silicone implants are real and they are serious," NOW says.

"If we talk about the device alone without the political sideshow, it's a safe device," says Dr. James Wells, a former president of the American Society of Plastic Surgeons.

"This implant has been studied more than any device on record," said Wells, a plastic surgeon based in Long Beach, Calif. "It's been looked at, dissected and re-looked at." Although no drug or device is free from risk, he adds, silicone implants should be allowed on the market if the product is deemed safe and patients are well-informed about risks and benefits.