FDA Advisory Committee Begins Three Days of Hearings on Safety of Silicone Breast Implants
An FDA advisory committee on Monday began three days of hearings to determine whether to recommend the removal of a 13-year ban on the sale of silicone breast implants to the general population, the AP/Washington Post reports (AP/Washington Post, 4/12).
FDA in January 2004 rejected the recommendation of a previous agency advisory committee to allow market re-entry for silicone breast implants manufactured by medical device company Inamed and said that the company had to conduct new studies to prove the safety of the implants. FDA limited the availability of silicone breast implants in 1992 to consider safety concerns, such as the effects of implants with leaks or ruptures.
Under current FDA rules, only women who seek breast enlargement or reconstructive surgery as part of clinical trials can receive silicone breast implants (California Healthline, 1/9/04). The committee this week will consider more detailed data on the safety of silicone breast implants manufactured by Inamed and Mentor, which have filed applications for agency approval to market the implants.
At the Monday hearing -- which lasted 15 hours -- more than 150 breast cancer survivors, women's rights advocates, plastic surgeons, women who received silicone breast implants and others testified before the committee (Neergaard, AP/Long Island Newsday, 4/12). The committee will consider the applications from Inamed and Mentor on Tuesday and Wednesday (Harris, New York Times, 4/12).
Many witnesses who oppose the removal of the ban on silicone breast implants testified that a link exists between silicone breast implants and higher suicide and cancer rates and other health problems (Henderson, Boston Globe, 4/12). Some researchers and physicians also have cited a link between silicone breast implants and fibromyalgia, a condition similar to chronic fatigue syndrome.
However, studies have failed to indicate a link between silicone breast implants and cancer, connective tissue disease, immune system disorders or other health problems (Alonso-Zaldivar, Los Angeles Times, 4/12). In 1999, the Institute of Medicine said that silicone breast implants are not linked with major diseases (New York Times, 4/12).
Women who support the removal of the ban on silicone breast implants testified that silicone is used in many other medical devices without safety concerns and that the ban has caused them "difficulty in getting what they called the most natural-feeling implant to rebuild cancer-ravaged breasts or to enlarge small ones," the AP/Post reports. Supporters of the removal of the ban on silicone breast implants also testified that the implants are available to the general population in many other nations (AP/Washington Post, 4/12).
Plastic surgeon Edward Melmed testified that he has removed 500 silicone breast implants from women since 1992 and that, among those patients, 50% who had the implants for 10 years experienced ruptures. The rupture rate for silicone breast implants increased to 70% after 15 years and to 94% after 20 years, he said (Boston Globe, 4/12).
Melmed added that most plastic surgeons support the removal of the ban on silicone breast implants because "first, it's a lucrative operation, and second, it's a lucrative operation" (Los Angeles Times, 4/12). According to one analyst, the removal of the ban on silicone breast implants could increase sales for the implants by $75 million by 2006 (Boston Globe, 4/12).
Melmed said, "No doubt there is a group of women who are sickened from their implants. It's usually diseases like fibromyalgia, a disease that there is no proof of. But the patients all feel lousy" (Los Angeles Times, 4/12).
Plastic surgeon Deborah Bash, who has silicone breast implants, testified that women should have the implants replaced every 10 years and that she has not experienced health problems because of the implants (Boston Globe, 4/12).
Inamed and Mentor officials have said that new silicone breast implants are less likely to rupture than earlier versions, although women must have them replaced after a certain number of years. The companies have compared silicone breast implants to hip replacements and pacemakers and have said that data indicate ruptures occur in between 1% and 21% implants in three to four years.
However, in a preliminary analysis, FDA said that the data submitted by the companies has "limited value" (AP/Long Island Newsday, 4/12). In an FDA analysis, researchers found that ruptures could occur in 75% of silicone breast implants in 10 years (AP/Washington Post).
National Organization for Women President Kim Gandy on Monday testified that more studies are required to determine the long-term health effects of silicone breast implants (Rubin, USA Today, 4/12).
Meanwhile, Michael Olding, chief of plastic surgery at George Washington University School of Medicine and Health Sciences and one of two plastic surgeons on the committee, on Monday withdrew because of "last-minute" conflict-of-interest concerns, the Globe reports. Olding also declined a nonvoting seat on the committee. "I regret I having to make this decision, as I possess important experience as a plastic surgeon for the panel to consider," he said. FDA did not name a replacement to the committee.
In addition, officials for the Center for Science in the Public Interest on Monday testified that Michael Miller, the other plastic surgeon on the committee, has a conflict of interest because he accepted $25,000 from Inamed and endorsed silicone breast implants as safe on a CD-ROM he produced that was sponsored by the medical device industry.
Merrill Goozner, integrity in science project director at CSPI, said, "Dr. Miller not only has a conflict of interest, but he has a point of view about the evidence he is about to hear" (Boston Globe, 4/12).
The "time is right" for FDA to remove the ban on silicone breast implants, Sally Satel, a scholar at the American Enterprise Institute, writes in a USA Today opinion piece.
She adds that FDA should "stipulate that augmented women become part of an active post-marketing surveillance" to provide "ample data about rupture rates" and confirm studies that indicate no link "between implants and systemic disease" (Satel, USA Today, 4/11).
Several broadcast programs reported on the FDA advisory committee hearing on silicone breast implants:
- APM's "Marketplace": The segment includes comments from Cybil Goldrich, co-founder of Command Trust Network, a national silicone information group; Dr. Maurice Nahabedian, a plastic surgeon who testified at the hearings; and James Wells, past president of the American Society of Plastic Surgeons; (Palmer, "Marketplace," APM, 4/11). The complete segment is available online in RealPlayer.
- CBS' "Evening News": The segment includes comments from Dr. Scott Spear, president of ASPS, and women who testified at the hearing (Kaledin, "Evening News," CBS, 4/11). The complete segment is available online in RealPlayer.
- NBC's "Nightly News": The segment includes comments from women who testified at the hearing (Bazell, "Nightly News," NBC, 4/11). The complete segment is available online in Windows Media.