From the AP wire. FDA advisers back lifting breast implant ban, in turnaround

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% 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. 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.

This week my [father][1] went to Washington, DC to testify before the FDA advisory panel on silicone breast implants. As a point of reference both my father and I are investigators for the Mentor Corporation for the silicone breast implants. The FDA may have a problem with point number two of their stricter criteria. Most surgeon who actually put in breast implants are probably not “board-certified plastic surgeons”. Most are “cosmetic” surgeons that come from a wide variety of training including having board-certification in plastic surgery, general surgery, ENT, Dermatology, OB/Gyn and others. I think that if the FDA tries to enforce this second point they are opening themselves up to a restraint of trade lawsuit. But IANAL. Emphasis is mine. [1]: http://www.fragencosmeticsurgery.com/