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.