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FDA panel backs halt to silicone implant ban

Turnaround comes one day after rival product rejected

WASHINGTON -- In a surprising turnaround, federal health advisers yesterday recommended allowing silicone-gel breast implants to return to the US market after a 13-year ban on most uses of the devices -- but only under strict conditions that will limit how easily women can get them.

Mentor Corp. persuaded advisers to the Food and Drug Administration that its newer silicone implants are reasonably safe and more durable than older versions. The 7-2 vote came just one day after a rival manufacturer, Inamed Corp., failed to satisfy lingering concerns about how often the implants break and leak.

The FDA's advisers said Mentor had performed more convincing research that the implants rarely break and only shortly after they're inserted -- about 1.4 percent over three years. They showed some evidence the implants may last up to 10 years. They stressed that sales should resume only if Mentor meets strict conditions:

Patients must sign consent forms acknowledging implant risks, including that they ultimately may break and require removal or replacement.

Mentor may sell silicone implants only to board-certified plastic surgeons who complete special training.

Mentor must open a registry to track how patients fare, and continue more formal studies to nail down how often implants rupture within 10 years, something no one yet knows.

Mentor must warn that because implant breaks don't cause immediate symptoms, patients should get an MRI scan five years after implant insertion and every two years after that.

''We are holding it to higher standards than other implants," said FDA adviser Stephen Li, a Florida medical device-testing expert. ''This device has a 30-year history that, at best, is checkered."

''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," added Dr. Marilyn Leitch, a cancer surgeon at the University of Texas Southwestern Medical Center who also supported Mentor sales.

But Mentor's best research tracked implant recipients for only three years, said New York dermatologist Dr. Amy Newburger, who opposed allowing widespread sales. ''I don't have the assurance that it's safe."

The advisers wrestled with the decision and acknowledged it was a surprise given their harsh criticism of competitor Inamed's bid to sell its own silicone implants. ''They're two different devices. . . . We didn't have nearly the questions on this that we had on the prior application," Li said.

In extended trading on the New York Stock Exchange, Mentor shares surged 12 percent, or $4.27, to $39.60, adding to a 77-cent gain in the regular session, before the FDA news.

The FDA isn't bound by advisers' recommendations. Just 15 months ago the FDA overruled a recommendation by the panel to bring back gel implants, telling manufacturers it needed better data on durability and silicone leakage before lifting restrictions that since 1992 have limited silicone implants to use only in special research studies.

Implant critics bemoaned the latest recommendation.

''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?"

The recommendation was a big boost for Mentor. But Inamed vice president Dan Cohen said his company isn't out of the running, saying the FDA's advisers had made ''bizarre and strange decisions" in demanding stricter data from one firm than the other.

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 health fears.

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.

About 264,000 breast enlargements were performed in the United States last year, and 63,000 breast reconstructions, the vast majority with salt water-filled implants that today are sold without restriction.

Consequently, Newburger estimated that if silicone-gel implants return to the market, 200,000 women might seek them in the first year -- meaning side effects that occur in only one in 10,000 people will become an issue.

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