Dr Fragen in the operating room

Silicone Breast Implants Are Back?


From the AP wire.
[FDA advisers back lifting breast implant ban, in turnaround](http://www.usatoday.com/news/washington/2005-04-13-breast-implants_x.htm?csp=34)
>[Mentor Corp](http://www.mentorcorp.com). 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/