"We feel that this is an unfair decision, particularly because a major portion of those who participated in the clinical trials that led to this decision were cosmetic surgeons," says Claude H. Crockett Jr., M.D., F.A.C.S., president of the American Academy of Cosmetic Surgery (AACS). "We're working towards overturning this suggestion and implementing fairness in the inserting of these implants."
"This recommendation may not be sustainable for many reasons," says plastic surgeon V. Leroy Young, M.D., of the BodyAesthetic Plastic Surgery and Care Center, St. Louis."The very fact that there may be an antitrust issue involved due to the recommendation's limitations, and the fact that some general surgeons are much more qualified to insert implants than a first-year plastic surgeon, are reasons that are powerful enough (to overturn this recommendation) prior to the final ruling."
But even with scientific data indicating that Mentor's implants show a rare breakage rate of about 1.4 percent over three years, and some evidence indicating that they may last as long as 10 years, FDA advisers were firm in stressing that sales of the implants should resume only if Mentor meets the following strict conditions:
Other recommendations The panel also recommended that patients get an MRI scan five years after the insertion of the implants and every two years thereafter. Consideration of removing broken implants is also suggested to minimize the risk of silicone migrating into the breast or beyond.
Although the suggested restrictions were designed to support patient safety, the recommendation to limit who inserts the devices has caused consternation among cosmetic surgeons.
Proper training is key While the rationale for the limitation is that it theoretically will reduce the complication rate, the key is to make certain that proper training is part of the equation, according to Michael J. Olding, M.D., chief of plastic surgery, George Washington University Medical Center, and spokesman for the American Society of Plastic Surgeons.
"These should be implanted by those who have a full understanding of who best benefits from silicone — very thin women with small breasts and those with very little subcutaneous tissue, such as breast reconstruction patients.
"The panel wants to make certain that patients have every opportunity to have the best results," says Dr. Olding, who served on a 2003 FDA panel that reviewed a pre-market approval bid by Inamed for its silicone-gel implant. Although the panel recommended approval, the FDA turned the request down.
"Understandably, not every cosmetic surgeon performs breast implants," Dr. Crockett says. "But a majority (of implant procedures) are completed by non-plastic surgeons. The panel's recommendation is not only being looked at closely by the AACS, but also by the manufacturers."