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.
The FDA does not comment on upcoming panel meetings. But in a recent letter to House Commerce Chairman Charles Bliley, R-Va., it did say: "The FDA believes that women can evaluate the risks versus the benefits of breast implants for their personal situation if they are well-informed about the rate of infection and other local complications." The Jan. 14 letter was sent in response to a conference call between committee members and the FDA, during which the agency was asked whether it believed that patients are adequately notified of the risks and whether these devices fulfill an important medical need.
The upcoming March meeting, though, is most likely to focus on saline breast implants, which replaced silicone breast implants as a first-line option after the FDA called for a moratorium on the use of silicone in 1992. However, says Harlan Pollock, MD, "There is no question that silicone implants are better in terms of overall results." Pollock, who is the public education chairman for the American Society of Plastic Surgeons, adds that the greatest risk to patients is not from the medical devices, but from unscrupulous surgeons performing procedures outside their specialty.
"It is important to understand that these implants are not sold directly to patients," says David Barella, the executive vice president of marketing for McGhan Medical Corporation of Santa Barbara, Calif. McGhan, the maker of saline implants, includes pages and pages of device information for the physician's review, which Barella believes more than adequately addresses the labeling issues.
The 1992 scare regarding silicone breast implants, "was all based on junk science," he says. Consumers' present interest in breast implants cannot be credited to their growing confidence in the safety of silicone devices since the newer devices are made from saline. "But we do hear from physicians and patients that they prefer silicone implants for their natural feel."
Silicone breast implants presently are being studied again for use in the U.S. But whether consumers actually will return to silicone breast implants remains to be seen. The only given at present is that consumers have regained their interest in breast augmentation. Although the procedure primarily is an elective surgery, about 134,000 procedures were performed in 1998, and "I expect those figures to be about 10-15% higher for 1999," Barella tells WebMD.