- The Washington Times - Wednesday, April 13, 2005


In a surprising turnaround, federal health advisers yesterday 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 yesterday that Mentor had carried out more convincing research that the implants only rarely break in the first few years after they are inserted — about 1.4 percent over three years — and showed some evidence 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 in the long term, and continue more formal studies to determine how often implants rupture within 10 years.

Because implant ruptures don’t cause immediate symptoms, patients should get a magnetic resonance imaging (MRI) scan five years after their implant is inserted and every two years thereafter. They should consider having ruptured 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,” Dr. Newburger said.

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,” Mr. 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.

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