FDA Advisory Committee Chair Calls Vote on Silicone Breast Implants ‘Misguided’
The chair of the FDA advisory committee that voted 9-6 last month to recommend allowing silicone breast implants back on the market sent a "highly unusual" letter to FDA Commissioner Dr. Mark McClellan and five members of Congress on Friday urging the rejection of the panel's decision, calling it "misguided" and possibly dangerous to women, the Boston Globe reports. Dr. Thomas Whalen, a four-year member of the FDA's plastic surgery advisory panel and chief of pediatric surgery at the New Jersey-based Robert Wood Johnson Medical School, cited the absence of long-term data provided by California-based silicone implant manufacturer Inamed, which presented safety information on the implants spanning two to three years. He said that the FDA should have required at least 10 years of safety data. Whalen also cited evidence that emerged during the hearings of the possible danger of silicone implants obscuring early signs of cancer in mammograms (Rowland, Boston Globe, 11/5). In addition, he said he found the "enormous costs" that face women if they need additional surgeries or the removal of painful or broken implants "extraordinarily troubling," the AP/Las Vegas Sun reports (AP/Las Vegas Sun, 11/4). Whalen did not cast a vote in the October decision because advisory committee chairs only vote on recommendations in the event of a tie (Boston Globe, 11/5). The FDA panel last month held a two-day hearing on expanding the availability of silicone implants for general use, hearing 25 hours of testimony from 107 witnesses including researchers, Inamed officials and patients who had received the implants. Under current FDA rules, only women who seek breast enlargement or reconstructive 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 then have not settled questions about their safety (California Healthline, 10/16).
Sen. Edward Kennedy (D-Mass.), who received a copy of Whalen's letter, said in a statement, "The chairman's letter raises serious new questions about the issue," adding, "If convincing answers aren't forthcoming, additional research will be needed to demonstrate the implants are safe before any change is made." Cynthia Pearson, executive director of the National Women's Health Network, which opposes approval for silicone implants reentering the market, said, "The fact that the chair of the committee said he was willing to vote against it says this is a question on which really rigorous, very credentialed people can come to the conclusion that we don't know enough." However, some members of the American Society of Plastic Surgeons called Whalen's letter "disingenuous" and "strange," the Globe reports. Dr. James Wells, former president of the society, said, "For him to come out with this kind of letter now is wholly inappropriate," adding, "He had access to a microphone. He could make any comments he wanted, and he chose not to." Whalen said he did not voice his concerns during the hearing because he believed his role as chair required him to remain neutral at that time, according to the Globe. Inamed refused to comment directly on Whalen's letter. The FDA, which almost always follows advisory panel recommendations, also said Tuesday that because officials had just received the letter, there was no comment yet (Boston Globe, 11/5).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.