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Lauran Neergaard

Thursday, Apr 14, 2005 12:34 PM UTC

FDA panel backs lifting breast implant ban

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WASHINGTON (AP) — Silicone-gel breast implants, virtually banned for 13 years, would return to the market if the government heeds a surprising recommendation from its scientific advisers.

After three days of wrenchingly emotional debate, advisers to the Food and Drug Administration said Mentor Corp. should be able to sell its gel implants — but only if it meets strict conditions.

Topping that list: ensuring women understand the devices may silently break inside their bodies; recommending that they get regular, and expensive, MRI exams to check for those breaks; limiting implant insertion to specially trained plastic surgeons; and new studies to prove how long implants last.

Just a day earlier, the advisers narrowly rejected sale of rival manufacturer Inamed Corp.’s silicone implants, citing lingering questions about how long they last and what happens when silicone oozes into the breast, or beyond.

By a 7-2 vote, the FDA advisers said Mentor’s research was more compelling than its competitors’ that it was time to lift restrictions that, because of health concerns, limited gel implants to special research studies since 1992.

“Patients can determine whether or not for them it is worth it to have a device that might need to be replaced within a 10-year period of time,” said Dr. Marilyn Leitch, a cancer surgeon at the University of Texas Southwestern Medical Center.

Mentor hasn’t proved they’ll last even 10 years, argued New York dermatologist Dr. Amy Newburger, who opposed lifting restrictions. Instead, it closely studied patients for just three years and didn’t settle concern about the consequences of silicone leaks.

“I don’t have the assurance that it’s safe,” Newburger said. “My concern was, since hundreds of thousands of patients will be exposed to this, I felt that the urgency (to sell) was not warranted at this time.”

The FDA isn’t bound by its advisers’ recommendations. Just 15 months ago the FDA overruled a recommendation to bring back gel implants, telling manufacturers it needed better data on durability and silicone leakage.

Still, the decision was sure to delight patients who contend silicone-gel implants look and feel more natural than the salt water-filled implants sold without restriction.

“If I had the option today, I would choose silicone over saline,” Arlene Nicole Cummings, a saline implant recipient who runs a Web site for women considering breast implants, told the FDA advisers. “Women, along with their surgeons, should be allowed to choose. … We are neither ignorant nor shallow.”

The decision was a blow to dozens of other women who told the panel of silicone oozing out of their bodies and of years of pain and other symptoms they blame on faulty implants.

“These conditions are unenforceable,” said Sybil Goldrich, a breast cancer survivor who went through four sets of broken implants in the 1980s. “Who’s going to pay for that MRI?”

The advisers acted on “wishful thinking” instead of data, said Cynthia Pearson of the National Women’s Health Network. “How can you ask women to consent based on a lot of unknowns?”

Silicone-gel breast implants began selling in 1962, before the FDA required proof that all medical devices are safe and effective. The FDA imposed its ban on most use of the implants in 1992 amid fears that leaking silicone was dangerous.

Today, gel implants largely have been exonerated of causing serious or chronic illnesses such as cancer or lupus. But aside from the risk of breakage, they can cause infection and painful, rocklike scar tissue.

Mentor’s chief study tracked about 400 women for three years and found 1.4 percent suffered implant ruptures. It also cited 100 patients given Mentor implants by a British doctor, whose own tracking found 5 percent broke within about nine years of insertion.

FDA scientists said Mentor’s data was too limited to settle durability questions and that the British research was skewed because it included only volunteers and excluded patients at highest risk of implant rupture — those with serious scar tissue.

But the advisers found the data reassuring, saying it was supplemented by state-of-the-art mechanical testing that suggests the implants are strong.

The panel harshly criticized Inamed Corp., which had tracked about 900 patients for three or four years to find between 2 percent and 10 percent implant breakage.

The turnaround shocked Inamed Vice President Dan Cohen, who said the panel had made “bizarre and strange decisions” in demanding stricter data from one firm than the other. He said his company would pursue approval.

The two devices are different and Mentor’s studies were better, FDA adviser Stephen Li, a Florida medical device-testing expert, said to explain the differing views.

“We are holding it to higher standards than other implants,” Li said. “This device has a 30-year history that, at best, is checkered. Given that history, it behooves us to have a higher standard.”

About 264,000 breast enlargements and 63,000 breast reconstructions were performed in the United States last year.

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