FDA backs lifting silicone breast implant ban

updated 11:05 a.m. ET April 14, 2005

WASHINGTON - 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.

MORE FROM MORE HEALTH NEWS

More Health News Section Front

One heart, one widow connect suicides of 2 men It’s back-to-school time for bedbugs Now hear this: Don't remove earwax 1 in 10 Native American deaths alcohol related Flying’s a literal headache for many travelers Cells switch identity in biological breakthrough Indonesia's 'tree man' home after surgery Tongue's sixth 'taste' discovered — calcium Spike in vitamin D testing creates confusion Look out! 'Beer goggles' are real More Health News Section Front   Add More Health News headlines to your news reader: