Feb. 8, 2000 (Washington) -- An FDA expert panel meeting, soon to be held, is going to attempt to finally address the safety issues surrounding breast implants. Although the panel meeting probably will offer implant recipients some element of further confidence in their decision, experts say the conclusion most likely will be that the final decision for augmentation always rests with patients and their confidence in their physician.
At that March meeting, the FDA panel will hear that breast implants are safe and effective medical devices and that almost all patients are aware of the risks before undergoing surgery, Bruce Cunnigham, MD, MS, director of the department of plastic and reconstructive surgery at the University of Minnesota in Minneapolis, tells WebMD. "In my mind," says Cunningham, who was the lead researcher of the safety studies to be submitted to the FDA on behalf of the manufacturers, "there is no question that they represent an acceptable risk."
In the study headed by Cunningham, the overall risk of device failure was about 5% per device per year, or about 10% per patient, in contrast to the manufacturers' original estimates of about 2.5% per device. But in terms of complications, such as capsular contracture, which is when the outside of the implant shrinks, and infection, those risks currently are estimated properly on the label, Cunningham notes. In addition, he tells WebMD that a survey of the patients participating in his study showed that about 90% of the patients were aware of these risks.
Those figures, however, are contrary to other published studies, but it is unlikely that manufacturers are withholding known safety data, according to Leroy Young, MD, a professor of surgery at Washington University in St. Louis. The big question at the panel meeting, Young tells WebMD, probably will be concerning the rupture rate of the implants and what that figure means in terms of whether the implants eventually need to be removed or replaced. "I tell most of my patients that their implants probably will have to be replaced over the next 10 years," he says.