Jan. 24, 2000 (Washington) -- A new chapter in the ongoing saga of breast implant safety is about to unfold as an expert advisory committee to the FDA will meet in March to discuss the best ways to study the long-term effects of implants.
Underlying the meeting are very clear indications that the FDA is in favor of approving saline-filled breast implants -- products that, while available for a quarter of a century, have never been formally approved by the agency. A decision whether to formally approve silicone-gel implants, which are much more controversial than saline-filled implants, will come later, but all indications are that FDA is favorably disposed to approving them as well.
The public meeting is likely to stimulate media stories about the safety of breast implants, a controversial subject in the last decade due to mass litigation by women who claim to have been harmed from them. Hopefully, the media will cover the story factually, since poor coverage in the early 1990s led many in the public to believe that FDA had found the implants unsafe. In fact, the agency's position was that there was insufficient scientific data to reach any conclusion.
The FDA's task over the next several months is to make sense out of the scientific information about breast implants -- recognizing that the products remain the subject of confusion and emotionalism -- and to make statements that clarify rather than frighten.
A recent letter sent by the FDA to a member of Congress made clear that the agency feels there is a need not only for saline-filled implants, but also for silicone gel-filled implants, at least for reconstruction following breast cancer surgery. "Saline-filled breast implants and new breast surgical techniques are not adequate for all women," the letter stated. "There continues to be a public health need for silicone gel-filled breast implants." The letter was sent to Rep. Thomas Bliley, R-Va., the chairman of the Commerce Committee, which oversees FDA activities.
Further evidence of the agency's views came in a December meeting with women's advocacy groups to discuss how best to inform potential patients about the risks associated with implants. The major topic of discussion was not whether to have breast implants available but rather how to warn women of potential negative effects. The women's groups feel that if implants are approved, women must be notified of their risks in graphic terms, including photos of women whose implants have failed.
Another central issue is what breast implants will be approved for. There are very clear signals that postoperative reconstructive surgery will be accepted by the FDA. It remains to be seen whether cosmetic surgery will be formally approved either for saline-filled or silicone gel-filled products.
Of course, no matter what the products are approved for, plastic surgeons may use them for whatever purpose they feel is in the best interests of their patients. Thus, women will still be able to obtain cosmetic surgery with either saline or silicone. Moreover, breast implants still are advertised to women.
In the letter to Bliley, FDA said that it 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 that occur." The agency cited a study in TheNew England Journal of Medicine published in March 1997 that found that infections occurred in 2.5% of the women undergoing implants. "Other local complications include rupture, pain, ... and disfigurement, all of which may lead to medical interventions and repeat surgeries," the letter stated.
The agency made clear in the Bliley letter that if breast implants are approved, "specific risk-related information will be provided in the product label."
Another sure thing is that if the FDA approves the products, it will require long-term studies of safety. This is the immediate focus of the expert advisory committee meeting in early March.