Feb. 3, 2006 -- A report issued Friday cautions against the likely return of silicone breast implants to the U.S. market, warning that companies have not performed long-term safety studies in breast cancer patients.
The FDA is expected to soon clear two companies' silicone implants for U.S. sales after a nearly 14-year partial ban.
The implants are used for women seeking cosmetic breast enhancement and breast cancer patients and others needing reconstruction after mastectomies. Concerns over ruptures and the possible health effects of silicone leakage into the body had kept silicone implants off the cosmetic surgery market.
Friday's report concludes that the companies have not properly studied the implants' safety in women with cancer.
"The main focus of this report is really the missing data, the research that hasn't been done," says Diana Zuckerman, PhD, president of the National Research Center for Women and Families, which issued the report.
Last April, an FDA advisory panel voted 5 to 4 to reject Inamed's bid to sell silicone implants, citing a lack of long-term safety data. The next day the panel voted 7 to 2 to allow Mentor to sell its implant, which appeared to be more durable and less likely to rupture.
Inamed's study showed that 5% of women with the implants experienced ruptures within three years of surgery. Company projections concluded that 14% of the implants could be expected to break after 10 years of use, but patients were not actually followed for that period of time.
Inamed officials say that they could not link any of the ruptures in their study to serious health effects and instead only found an increased likelihood of local symptoms like pain and breast hardness around broken implants.
But experts at the time criticized the company for not conducting long-term safety trials. An FDA analysis projected that as many as 93% of women could experience ruptures after 10 years of use.