An FDA group of advisors has changed its view and recommended allowing women to obtain silicone breast implants, from Mentor Corporation, with certain reservations. It is not clear how this decision relates to a recent ruling we wrote about (Inamed Corp implants). But the FDA advisors have suggested the following set of guidelines, according to the Associated Press:
— 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 it must 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. 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.”
