FDA Advisory Panel To Consider Silicone Breast Implant Approval
The FDA has scheduled an Oct. 14 meeting of an advisory panel to consider an application from Santa Barbara, Calif.-based Inamed for approval of its silicone breast implants, the Wall Street Journal reports (Wilde Mathews, Wall Street Journal, 10/2). The FDA in 1992 limited the availability of silicone breast implants to participants in clinical trials conducted to assess safety questions such as the effects of implants with leaks or ruptures (California Healthline, 7/21). Numerous studies conducted since the FDA limited the use of silicone implants "haven't settled the fight" over silicone implants' safety (Wall Street Journal, 10/2). In 1997, a study conducted by researchers at the National Cancer Institute found no conclusive evidence that linked silicone implants to cancer, but it found a slight statistical link between some types of connective tissue disease and leaking breast implants. In addition, the study found that 23% to 64% of removed implants examined had some form of tear (California Healthline, 7/21). Inamed plans to "reope[n] the debate" by asking for FDA approval of a silicone implant that is similar to earlier silicone versions. Inamed officials are scheduled to present the findings from a clinical trial tracking 940 women with silicone breast implants over two to three years. Inamed officials said the new research and older research indicate silicone implants do not pose long-term health risks, but they declined to release details of the research.
The Wall Street Journal reports that the advisory panel meeting is expected to be "an emotionally charged forum" for people on both sides of the issue (Wall Street Journal, 10/2). In anticipation, the FDA has scheduled the first day of the meeting to last from 8 a.m. to 10 p.m. -- about five hours longer than a typical advisory panel meeting -- to accommodate all who wish to speak (Rubin, USA Today, 10/1). Groups opposing approval of the silicone implants, including the National Organization for Women, plan to rally on Wednesday outside HHS headquarters in Washington, D.C. (Wall Street Journal, 10/2). In addition, the consumer advocacy group Public Citizen last week petitioned the FDA to postpone the two-day meeting until the agency releases the names of all the advisory panel members (USA Today, 10/1). Meanwhile, a coalition of breast cancer groups has written to the FDA requesting easier access to silicone implants for breast reconstruction (Wall Street Journal, 10/2).
In related news, three recent studies have found that women who have received cosmetic breast implants are significantly more likely to commit suicide than women who have not, the Washington Post reports. A new study of 2,166 Finnish women published Wednesday in the Annals of Plastic Surgery found that women who received cosmetic implants were more than three times more likely to commit suicide than the general population. The study's findings are similar to those from a study of Swedish women and a study of American women by the National Cancer Institute. The three studies also found that the overall death rate of women with implants was equal or lower than that of the general population, which could indicate that the implants were not causing illness, according to the Post. The studies did not include women who received breast implants after mastectomies. None of the studies determined reasons for the higher suicide rate among women who receive cosmetic implants. Some researchers said the psychological makeup of women who receive cosmetic implants could play a factor in the higher suicide rates because such women may be more likely to have psychological problems than women in general. However, other researchers said the higher suicide rates could be linked to the "difficulties and pain" associated with receiving implants. In an article accompanying the Finnish study, David Sarwer, a professor at the University of Pennsylvania, said that plastic surgeons should take greater care to understand the psychological and emotional states of patients seeking implants (Kaufman, Washington Post, 10/2).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.