Independent FDA Committee Begins Two-Day Hearing on Silicone Breast Implants
An independent FDA committee on Tuesday began a two-day hearing to consider a request by California-based Inamed that the agency allow market reentry of silicone breast implants for general use, the AP/Las Vegas Sun reports. Under current FDA rules, only patients who seek breast enlargement or reconstruction surgery as part of clinical trials can receive silicone breast implants; other consumers have to receive saline implants (Neergaard, AP/Las Vegas Sun, 10/14). The FDA limited the availability of silicone breast implants in 1992 to consider safety concerns, such as the effects of implants with leaks or ruptures. A number of studies conducted since the FDA limited the use of silicone breast implants have not settled questions about their safety (California Healthline, 10/2).
The 19-member FDA committee, headed by Dr. Thomas Whalen, chief of pediatric surgery at the Robert Wood Johnson Medical School, on Tuesday heard testimony from physicians, plastic surgeons and patients who had received silicone breast implants. The committee also questioned Inamed officials about the incidence of ruptures, the effects of implant replacements and other complications. Inamed officials "often did not respond with specific answers" but cited a three-year study that found high satisfaction with silicone breast implants, the New York Times reports (Kolata, New York Times, 10/15). The study, which began in 1999, involved 940 women who received silicone breast implants. According to the study, 20% of participants who had breast enlargement surgery had complications within three years that required additional surgery, and 40% of women who had breast reconstruction surgery had complications. The study also found that participants had "consistently more health complaints" in eight areas, the Washington Post reports. In addition, the study found that participants were satisfied with their silicone breast implants, although their satisfaction decreased over time (Kauffman, Washington Post, 10/14). FDA and Inamed officials agree that studies have not indicated a link between silicone breast implants and serious disorders such as lupus (AP/Las Vegas Sun, 10/14). However, testimony from Inamed officials "contrasted sharply" with testimony from more than 20 women who described the adverse effects that resulted from their silicone breast implants, the Los Angeles Times reports (Kemper, Los Angeles Times, 10/15). The committee will likely to issue a recommendation on the Inamed request on Wednesday after the hearing ends. The FDA will likely follow the recommendation of the committee (Martin, Chicago Tribune, 10/15).
Several broadcast programs reported on the FDA committee hearing on silicone breast implants:
- CBS' "Evening News": The segment includes comments from Dr. Nolan Karp of the New York University School of Medicine, Joanne Kuhne of Inamed and Dr. Sidney Wolfe, director of the Health Research Group at Public Citizen (Kaledin, "Evening News," CBS, 10/14). The full segment is available online in RealPlayer.
- CNN's "Live Today": The segment includes comments from witnesses at the hearing (Cohen, "Live Today," CNN, 10/14). The full transcript of the segment is available online.
- MPR's "Marketplace": The segment includes comments from Dr. James Wells, president of the American Society of Plastic Surgeons and Inamed Executive Vice President Hani Zeini (Henn, "Marketplace," MPR, 10/13). The full segment is available online in RealPlayer.