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 failed to satisfy lingering concerns about how often the implants break apart and leak inside women's bodies.
On Wednesday, FDA's advisers said Mentor had performed more convincing research that the implants only rarely break in the first few years after they're inserted, and some data that they may last as long as 10 years.
But they stressed that sales should resume only if Mentor meets some strict conditions:
Because implant breaks don't cause immediate symptoms, patients should get an MRI scan five years after their implant is inserted and every year or two thereafter — and have broken implants removed to minimize risk of silicone oozing into the breast, or beyond.
"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 FDA adviser Dr. Marilyn Leitch, a cancer surgeon at the University of Texas Southwestern Medical Center who supported Mentor sales.
Silicone-gel breast implants began selling in 1962, before the FDA required proof that all medical devices are safe and effective. The implants were banned back in 1992, after thousands of women complained they ruptured and caused immune system diseases, joint problems and even suicides. But medical studies have never been able to prove the link, and now only women who have had breast cancer can opt for silicone, reports CBS News Correspondent Elizabeth Kaledin.
Thirteen years later, silicone implants largely have been exonerated of causing serious or chronic illnesses such as cancer or lupus. But they can cause side effects, including infection and painful, rocklike scar tissue. Also, they can break, requiring additional surgery to remove or replace them — and those ruptures can result in silicone oozing into the breast and, sometimes, farther into the body.