Health

FDA refuses to allow gel implants

WASHINGTON - The government will continue its decade-plus ban on most silicone gel breast implants, health officials said Thursday, saying they have serious questions about how often the devices break apart and the damage that can result.

The Food and Drug Administration rejected Inamed Corp.'s bid to bring back silicone implants and outlined new guidelines for all manufacturers on the scientific issues that must be settled if the devices are to return to the market.

Key is answering questions about the gel that can ooze into a woman's breast, and sometimes beyond, when the implant breaks.

"We're quite convinced that there are women who have these products and get a very satisfactory result," said FDA medical device chief Dr. David Feigal. "The point isn't to talk about how many have a good result and how many have a rupture. What you really need to know is, for someone who has a rupture, what are the consequences of that?"

The FDA's decision was a surprise because the agency's scientific advisers in October had reluctantly recommended, on a 9-6 vote, approving Inamed's implants. Instead, FDA incorporated that panel's lingering concerns into the new guidelines. Companies must: settle whether women whose implants leak silicone without symptoms need them removed, do mechanical testing to predict how long implants will last before rupturing and do more detailed exams of what happens when silicone leaks beyond the breast.

"The products do not have to be complication-free," Feigal stressed - no medical device is. "We very much would like to work with manufacturers so they can find products which will provide options and will have an acceptable" list of side effects.

The FDA's move doesn't end controlled studies that make the once popular implants available to some women with breast cancer and a few other conditions.

But it could delay for several more years the return of silicone implants, meaning the main option for most women, especially those who want bigger breasts, will remain implants filled with salt water. Some 236,000 American women underwent breast enlargement in 2002.

Inamed was disappointed but pledged to seek FDA approval again.

"We see this as a setback but by no means do we see this as the end of the road," Inamed chief executive Nick Teti said. "We are confident we can provide the information," but he wouldn't estimate how long it would take.

Inamed had argued silicone implants break no more frequently and are no riskier than saline-filled ones. In studies tracking women for three years, up to 46 percent of Inamed recipients needed additional surgeries because of painful scar tissue and other complications, and up to a quarter had to have the devices removed or replaced.

Mentor Corp., a competitor, filed an FDA application for its silicone implants last month, and didn't immediately comment on whether it could meet the guidelines.

The decision delighted women's and consumer advocacy groups that had intensely lobbied the FDA to keep the implants banned.

"At last they've heard us," said Sybil Goldrich, a breast cancer survivor who complained about implants to the FDA 15 years ago. Goldrich went through four sets of broken implants in the 1980s.

Now that FDA has provided explicit advice to manufacturers, "I really hope they'll be able to make a product that works," she said. "If we can put a man on the moon and get a little machine to explore Mars, it seems to me you could make a good breast implant."

But the move disappointed plastic surgeons, who say silicone implants have been exonerated as causes of serious disease and are more natural looking than saline alternatives - and recipients understand that, just like pacemakers or artificial hips, they don't last forever.

"We support the scientific process" but "it seems they're changing the rules in the middle of the game here," said Dr. Rod Rohrich of the University of Texas Southwestern Medical Center, who is president of the American Society of Plastic Surgeons.

"It would have been laudable for the FDA to give these guidelines to the manufacturers a long time ago."

But Feigal said evolving science raised new questions which researchers now should be able to answer.

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