Image: FDA adviser Stephen Li
Kevin Wolf  /  AP
FDA adviser Stephen Li questions Inamed executives about silicon implants breaking during a meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee on April 12.
updated 4/14/2005 11:05:41 AM ET 2005-04-14T15:05:41

In a surprising turnaround, federal health advisers Wednesday recommended allowing silicone-gel breast implants to return to the U.S. 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 apart and leak inside women’s bodies.

FDA’s advisers said Wednesday that Mentor had performed more convincing research that the implants only rarely break in the first few years after they’re inserted — about 1.4 percent over three years — and showed some evidence that they may last as long as 10 years.

But they stressed that sales should resume only if Mentor meets some strict conditions:

  • Prospective 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 hands-on training to insert implants in a way that minimizes odds of breakage.
  • Mentor must open a registry to track how patients fare long-term, and continue more formal studies to nail down how often implants rupture within 10 years, something no one yet knows.

Because implant breaks don’t cause immediate symptoms, patients should get an MRI scan five years after their implant is inserted and every two years. They should consider having broken implants removed to minimize risk of silicone oozing into the breast, or beyond.

“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. Given that history, it behooves us to have a higher standard.”

“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.

Women must understand that Mentor’s best research has tracked implant recipients for only three years so far, said New York dermatologist Dr. Amy Newburger, who opposed allowing widespread sales.

“I don’t have the assurance that it’s safe,” Newburger said.

'They're two different devices'
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.

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“They’re two different devices. ... We didn’t have nearly the questions on this that we had on the prior application,” Li said. “Those are the reasons that will let me sleep at night.”

The FDA isn’t bound by its 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.

Silicone-gel breast implants began selling in 1962, before the FDA required proof that all medical devices are safe and effective. In 1992, complaints that the implants broke and caused illnesses prompted the FDA to ban gel implants except for patients with breast cancer or a few other conditions who enrolled in strict research studies.

Thirteen years later, silicone implants largely have been exonerated of causing serious or chronic illnesses such as cancer or lupus. Aside from the risk of breakage, they also can cause infection and painful, rocklike scar tissue.

Some 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.

Like Inamed, Mentor has tracked breakage rates for only three years in a study of about 400 people.

More reassuring to the panelists was research from a British doctor who tracked 100 of his own patients and found 5 percent of Mentor implants had broken by around nine years.

FDA scientists said the British research was skewed because it included only volunteers and excluded women at high risk of implant rupture because of rocklike scar tissue.

More troubling, when women in Mentor’s study chose to have their implants removed and not replaced, they were dropped from the study, Newburger said. That means no one knows if those women continued to suffer side effects.

Mentor pledged to continue study to answer outstanding questions, and it argued that silicone implants provide enough benefit that it’s unfair to withhold them from women in the meantime. Silicone-gel implants look and feel more natural than saline versions — and in Europe, where both types are sold, silicone implants are by far the most popular, the company said.

“Self-esteem ... is as integral to health and well-being as any medical issue,” said Mentor chief executive Josh Levine.

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