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Return of silicone implants rejected

The Food and Drug Administration has rejected Inamed Corp.’s bid to bring silicone gel breast implants back on to the market, the company announced.

The government will continue its decade-plus ban on most silicone gel breast implants for now, health officials announced Thursday, saying they still 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 ever 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 move doesn’t end strictly controlled research studies that make the once highly 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 likely to seek approval in future
Inamed expressed disappointment but pledged to seek FDA approval again, although officials didn’t say how quickly they could gather additional evidence.

Inamed had argued that silicone implants break no more frequently and are no riskier than saline-filled ones. In studies tracking women for three years so far, 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 first 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.”

Move disappoints some plastic surgeons
But the move disappointed plastic surgeons, who say silicone implants have been exonerated as causes of serious disease, are more natural-looking than saline alternatives — and that 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 responded that evolving science raised new questions which researchers now should be able to answer.

FDA decision a surprise
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.

Breast implants began selling in 1962, before the law allowed the FDA to require proof that all medical devices are safe and effective. Complaints that they broke and caused illnesses began in the 1980s, and in 1992 the FDA’s virtual ban began.

Thousands of women sued the manufacturers; many suits ended in a major settlement approved in 1999. That same year, the Institute of Medicine declared there was no evidence that implants cause major illnesses like breast cancer or lupus, but warned that breaking, pain and other complications occurred frequently.