The Food and Drug Administration has recommended that silicone breast implants remain on the American market even though there is no data proving their safety while it considers new tests submitted by the manufacturers.
Pressure from women’s and other health groups resulted in FDA hearings in late November to determine whether the implants should be removed from the market.
Although silicone gel bags have been implanted in some 2 million American women in the last 27 years, the FDA never required safety effectiveness tests because the devices were marketed prior to the 1976 medical devices law requiring proof of safety and effectiveness.
In the hearings, the Public Citizen Health Research Group, founded by consumer advocate Ralph Nader, estimated that 155,500 women have had problems with ruptured or infected implants, and 123,300 others suffered from ones that hardened.
The FDA accepts that the implants have certain known risks and encourages plastic surgeons to discuss them with women prior to having surgery. These included a hardening of scar tissue around the implant, which sometimes causes pain, and a risk of the silicon seeping into the body, causing autoimmune diseases like rheumatoid arthritis or lupus. Breast implants can also hide suspicious lumps or confuse mammogram results, the agency said.
Although the agency has kept the devices on the market, some wonder whether they may not change their mind following review in early January of new evidence being submitted by plastic surgeon manufacturers. For one thing, no company has submitted information about the experiences of women with implants for more than a few months after the surgery.
The lack of conclusive evidence, remarked the panel during the hearing, was “appalling.”