FDA Committee Opposes Inamed Silicone Breast Implant Application
An FDA advisory committee on Tuesday voted 5-4 to recommend against agency approval of an application submitted by medical device company Inamed to allow the company to sell silicone breast implants to the general population because of concerns about a lack of long-term safety data, the Wall Street Journal reports (Wilde Mathews, Wall Street Journal, 4/13). On Monday, the committee began three days of hearings to determine whether to recommend the removal of a ban on the sale of silicone breast implants.
FDA in January 2004 rejected the recommendation of a previous agency advisory committee to allow market re-entry for silicone breast implants manufactured by 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 a clinical trial can receive silicone breast implants. Medical device company Mentor also has filed an application to sell silicone breast implants (California Healthline, 4/12).
Inamed officials on Tuesday presented rupture data from a study of 940 women who received silicone breast implants manufactured by the company for reconstruction after breast cancer, replacement of previous implants or breast augmentation. According to the data, the silicone breast implants had an average annual rupture rate of 1.4% over three years. Inamed estimated that the silicone breast implants would have a rupture rate of 14% over 10 years based on the data (Rubin, USA Today, 4/13).
However, FDA medical officers Sahar Dawisha and Pablo Bonangelino said that such estimates are not possible (Kaufman, Washington Post, 4/13). FDA officials presented a series of mathematical estimates in which the 10-year rupture rates ranged from 5% to 29% for women who received silicone breast implants in cosmetic surgeries and from 39% to 95% for those who received the implants in reconstructive surgeries (Alonso-Zaldivar, Los Angeles Times, 4/13).
In addition, FDA officials said that -- based on the Inamed data, which found that 86% of women who experienced ruptured silicone breast implants were not aware of the problem -- the "only way to study rupture rates rigorously is to screen implant patients regularly" with MRIs, the New York Times reports (Harris, New York Times, 4/13). According to Inamed officials, the high percentage of women who were not aware of ruptures demonstrated the structural integrity of silicone breast implants, but FDA officials and some committee members said that the "silent leaks could be worrisome because small amounts of silicone could leak out over years," the Post reports.
Inamed also presented data on silicone breast implants from abroad -- where they are sold to the general population -- that indicated low rupture rates when they were properly implanted.
Committee members said that the safety data presented by Inamed was incomplete and that the company must submit more data on the causes of leaks in silicone breast implants, the effects of leakage and the long-term health risks of intact implants. Committee member Amy Newburger, a dermatologist who voted against the Inamed application, said that the "hearing was premature," adding, "I don't feel secure about the safety issue. I don't see how we can get or give adequate informed consent for our patients based on the data we've seen" (Washington Post, 4/13). Newburger added, "We have to be really stringent in terms of determining these risks. We're looking at big, big numbers of people who will take advantage of the availability of these devices" (Henderson, Boston Globe, 4/13).
Committee members also raised concerns about silicone breast implant model 153, which appeared to have higher rupture rates than other models. According to committee member Stephen Li, president of a Florida company that tests medical devices who also voted against the Inamed application, silicone breast implants probably become more likely to rupture over time. "It just makes sense that the longer something goes on, the more failures you're going to get," he said (Wall Street Journal, 4/13). Li added that his was the "weakest of the no" votes on the committee and that he "would have voted unequivocally yes if we had (additional) data." He said, "We really don't know why this device is failing when it fails" (Los Angeles Times, 4/13).
Committee member Michael Miller, a plastic surgeon who voted in favor of the Inamed application, said that women who have a favorable risk-benefit profile "should be allowed to have the device" (Wall Street Journal, 4/13). "There are women who would benefit from these devices who don't have access to them," Miller said (New York Times, 4/13). He added, "I would love to know everything about the device," but that is "an impossible standard" (Boston Globe, 4/13).
Dan Cohen, vice president of global government and corporate affairs at Inamed, said that the company was "disappointed in the decision of the panel" but will "continue to work with the FDA to get this into approvable form" (Wall Street Journal, 4/13). He added, "We believe in our data and think it was strong."
Cohen said that Inamed will continue to develop silicone breast implants (Washington Post, 4/13). In addition, Inamed will continue the silicone breast implant study for a total of 10 years as planned, he said (USA Today, 4/13).
The committee will vote on the Mentor application on Wednesday, but "panel members are likely to have the same questions" about the safety and long-term health effects of silicone breast implants manufactured by the company, the Journal reports. Mentor has about one fewer years of silicone breast implant safety data than Inamed (Wall Street Journal, 4/13).
Thomas Gunderson, a Piper Jaffray analyst, said, "If Inamed doesn't make it, then Mentor won't. That's the way to handicap it: A negative for one is a negative for both" (Boston Globe, 4/13).
However, plastic surgeon and Mentor consultant Scot Glasberg said that the amount of silicone breast implant safety data presented by Mentor and Inamed might not "be different, but the data are different," adding, "Hopefully, the panelists will start fresh in their evaluation" (USA Today, 4/13). The Mentor data indicate that silicone breast implants manufactured by the company have less than a 5% rupture rate over three years (Neergaard, AP/Long Island Newsday, 4/13).
FDA could make a decision on the recommendations of the committee in six weeks to several months. FDA does not have to follow the recommendations of the committee. However, Diana Zuckerman, president of the National Research Center for Women and Families, said, "I don't think the FDA can afford to do anything embarrassing. Approving this product after this kind of vote would be very embarrassing" (Alonso-Zaldivar, Los Angeles Times, 4/13).
The "narrow debate" over whether to allow the sale of silicone breast implants to the general population is "missing ... the broader cultural questions, such as why a 17-year-old girl asks her parents for breast implants for a high school graduation gift," a Los Angeles Times editorial states.
"There may be little use in trying to restrict breast implants," but FDA could "insist" on "a sterner warning for what's become so casual a surgery," the editorial continues. Lawmakers also could "focus on ways of encouraging anti-implant campaigns, maybe even by subsidizing public service campaigns on the benefits of a really good push-up bra," the editorial states (Los Angeles Times, 4/13).
Several programs reported on the FDA advisory committee recommendation against the Inamed application:
- ABCNews' "World News Tonight": ABCNews' Lisa Stark discusses the recommendation (Stark, "World News Tonight," ABCNews, 4/12).
- NPR's "All Things Considered": NPR's Joanne Silberner discusses the recommendation (Silberner, "All Things Considered," NPR, 4/12). The complete segment is available online in RealPlayer.
- NPR's "Morning Edition": The segment includes comments from Laurie Casas, a plastic surgeon; Li; Zuckerman; and women who testified at the hearings (Silberner, "Morning Edition," NPR, 4/13). The complete segment is available online in RealPlayer.