FDA Panel Votes in Favor of Market Reentry of Silicone Breast Implants
An independent FDA advisory committee on Wednesday voted 9-6 to recommend approval of market reentry of silicone breast implants for general use, USA Today reports (Fackelmann, USA Today, 10/16). The committee made the decision after members held a two-day hearing and heard 25 hours of testimony from 107 witnesses, who included researchers, officials from California-based silicone breast implant manufacturer Inamed and patients who had received the implants (Kemper, Los Angeles Times, 10/16). Under current FDA rules, only women who seek breast enlargement or reconstruction surgery as part of clinical trials can receive silicone breast implants. 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. The hearing on Tuesday and Wednesday addressed an application by Inamed to expand the availability of silicone breast implants for general use (California Healthline, 10/15). The committee recommended approval for the application but included an "array of conditions" that Inamed must meet to address concerns about the safety risks of silicone breast implants, the Wall Street Journal reports (Wilde Mathews, Wall Street Journal, 10/16). Under the conditions, Inamed would have to work with the FDA to establish a model consent form for women who seek silicone breast implants; develop patient education materials about the implants; train plastic surgeons to handle the implants and diagnose ruptures; establish a product label that encourages women to seek annual examinations and MRIs every other year to detect ruptures in the implants; and collect information about children of women who receive the implants (Los Angeles Times, 10/16).
Committee members said that they "agonized" over their votes because few experts agree on the safety of silicone breast implants, the New York Times reports (Kolata, New York Times, 10/16). Although committee members "unanimously voiced concern over the lack of long-term data on the health risks," they concluded that the "best available studies showed that they were acceptable," the Washington Post reports (Kaufman, Washington Post, 10/16). Dr. Benjamin Anderson, a professor of surgery at the University of Washington-Seattle who voted in favor of the Inamed application, said, "I believe in the right to choice and informed consent" (Wall Street Journal, 10/16). At the hearing Wednesday, Inamed officials cited product improvements over the past 10 years, such as silicone breast implants with a "thicker shell" and "more cohesive gel" that have a rupture rate of about 1% per year, the New York Times reports. Opponents, however, raised concerns that Inamed did not prove the safety of silicone breast implants and that the conditions recommended by the committee to monitor women who receive the implants were inadequate. Dr. Diana Zuckerman, of the National Center for Policy and Research for Women and Families, said, "This was a triumph of wishful thinking over science" (New York Times, 10/16). The FDA could make a final decision on the Inamed application within a few months (USA Today, 10/16).
Two broadcast programs reported on the committee recommendation on silicone breast implants:
- NBC's "Nightly News": The segment includes comments from Joanne Kuhne of Inamed; Zuckerman; and witnesses at the hearing (Hager, "Nightly News," NBC, 10/15). The full segment is available online in Windows Media.
- NPR's "Morning Edition": The segment includes comments from Cynthia Pearson, executive director of the National Women's Health Network and Dr. Celia Whitten of the FDA (Harris, "Morning Edition," NPR, 10/16). The full segment is available online in RealPlayer.