In early April, the FDA's General and Plastic Surgery Advisory Panel recommended that the FDA approve Mentor Corp.'s implants, one day after recommending rejection of a similar application from Inamed Corp. The FDA has 180 days from the date of premarket application (PMA) hearings to decide for or against approval.
Already, controversy has arisen over the panel's recommendation that only board-certified plastic surgeons should perform implant procedures.Examining rupture rates According to George Orloff, M.D., chief of plastic surgery, Providence St. Joseph Medical Center, Burbank, Calif., "What they found out by looking at the facts was that a lot of the ruptures that occurred happened at the time of surgery. The FDA was motivated by that fact (to recommend) that surgeons must be appropriately trained.
Restricting implant procedures to plastic surgeons "would be the ultimate high road, because that's who is trained to put these in, not just in their residency or a weekend course, but they're trained to do implants in general," according to Rod J. Rohrich, M.D., chairman of plastic surgery, University of Texas Southwestern, and past president of the American Society of Plastic Surgeons (ASPS).
But due to the political element of the FDA process, he says, "it's probably going to turn out that one will have to be a properly trained, board-certified physician."
Restriction able to be upheld? Already, the proposed restriction may be moot. In late June, Miriam Provost, Ph.D., acting director, division of general, restorative and neurological devices, FDA Center for Devices and Radiological Health, sent a letter to Claude H. Crockett, Jr., M.D., F.A.C.S., American Academy of Cosmetic Surgery president stating, "FDA does not consider that particular Panel recommendation to be enforceable by the FDA." The statement reiterates the position she took during the April meeting.
"The FDA cannot enforce anything except approval or non-approval of a device," according to Laurie Casas, M.D., Evanston Northwestern Healthcare, and associate professor of surgery, Feinberg School of Medicine, Northwestern University. "In fact, enforcement is up to doctors, and the way we police in this country is through hospital privileges. When it comes to plastic surgery, I tell my patients, 'Be sure your physician has privileges to perform the (desired) procedure in a hospital setting.' Otherwise, patients may be putting themselves at risk of having an unqualified physician perform their surgery, which may lead to complications."
Future of silicone implants At press time, sources declined to speculate about the FDA's final answer, or when it will arrive.