FDA Advisory Committee Recommends Approval for Mentor Silicone Breast Implant Application
An FDA advisory committee on Wednesday, in a "surprising reversal," voted 7-2 to recommend the approval of an application submitted by medical device company Mentor to allow the company to sell silicone breast implants to the general population but also called for several conditions to regulate use of the implants, the Wall Street Journal reports (Wilde Mathews, Wall Street Journal, 4/14).
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. The committee on Tuesday voted 5-4 to recommend against approval of an application submitted Inamed to allow the company to sell silicone breast implants because of concerns about a lack of long-term safety data.
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 (California Healthline, 4/13).
Mentor officials on Wednesday presented data from a study of 420 women who received silicone breast implants that found 1.4% of the implants ruptured after two years. Mentor has completed three years of the 10-year study. According to the data, all the ruptures were "silent" -- participants were not aware of them until they underwent an MRI. Study participants received two MRIs during the two-year period (Harris, New York Times, 4/14).
The Mentor data indicated that about one in 200 silicone breast implants rupture within three years of implantation in women who receive them for cosmetic breast augmentation, but the rupture rate was higher in women who receive them for breast reconstruction.
Mentor officials also presented a study conducted by a British physician that indicated silicone breast implants manufactured by the company have a 5.4% rupture rate after an average of nine years. In addition, Mentor officials said that studies have found ruptured silicone breast implants do not cause adverse health effects other than occasional soreness or hardness in the breast (CQ HealthBeat, 4/13).
According to Mentor officials, studies indicate that silicone breast implants manufactured by the company last for 25 to 47 years and that 9% to 15% of women who receive them experience ruptures within 12 years (New York Times, 4/14).
The committee voted to recommend the approval of the Mentor application provided that the company meets nine conditions:
- Women must sign consent forms to acknowledge that they are aware of the potential risks involved with silicone breast implants, such as ruptures that might require replacement or removal;
- Mentor can sell silicone breast implants only to board-certified plastic surgeons who are specially trained to implant them to minimize the risk for ruptures;
- Mentor must establish a patient registry to track the long-term health effects of silicone breast implants;
- Silicone breast implant labels and patient information must advise women to receive an MRI five years after they receive the implants and every two subsequent years and to consider the removal of ruptured implants;
- Mentor must continue the studies on silicone breast implant rupture rates;
- Mentor must have the studies reviewed by an independent data monitor;
- Mentor must include in the studies patient analyses of women who have had silicone breast implants removed and not replaced;
- FDA must publicly review Mentor study data in five years; and
- Mentor must link with a tracking number silicone breast implants to women who receive them (AP/Las Vegas Sun, 4/14).
Committee member Stephen Li, president of Medical Device Testing and Innovations who voted against the Inamed application but in favor of the Mentor application, said that the Mentor data indicated silicone breast implants manufactured by the company "had an extremely low rupture rate" (New York Times, 4/14). "They are two different devices, made by two different companies," Li said (Wall Street Journal, 4/14). However, he said, "We are holding it to higher standards than other implants. This device has a 30-year history that, at best, is checkered" (Neergaard, AP/Boston Globe, 4/14).
Committee member Michael Miller, professor of plastic surgery at the University of Texas who voted in favor of both applications, said, "We don't have exhaustive knowledge about these devices. We have sufficient knowledge to justify their use" (New York Times, 4/14).
Committee member Amy Newburger, a dermatologist who voted against both applications, said, "I don't have the assurance that it's safe" (AP/Boston Globe, 4/14). She added that Inamed and Mentor should have waited to complete the 10-year studies on silicone breast implants before they presented data to FDA (Alonso-Zaldivar, Los Angeles Times, 4/14).
Committee member Brent Blumenstein, a statistician with TriArc Consulting who voted against both applications, said, "I think that there needs to be a lot more study of these things before we can conclude" that silicone implants are safe (CQ HealthBeat, 4/13).
FDA scientists said that the Mentor data was of "limited value." Sahar Dawisha, an FDA reviewer, said that the study of "the expected lifetime rupture rate" for silicone breast implants included only two to three years of data (Wall Street Journal, 4/14). In addition, Dawisha said that the British study presented by Mentor included only 100 women treated by a single physician and that the placement of the implants in the study was different than the placement in the company study (Rubin, USA Today, 4/14).
Diana Zuckerman, president of the National Research Center for Women and Families, said, "Overall, there was a mixed message here, and it's confusing. This will make it hard for the FDA" (Los Angeles Times, 4/14). She added, "Because of all the conditions, it's far from a done deal regarding the FDA. It's not helpful to women to have a product approved on the basis of two years of safety data" (Kaufman, Washington Post, 4/14).
In addition, "FDA has little power to enforce" the conditions recommended by an advisory committee "after it renders an approval," the New York Times reports (New York Times, 4/14).
Mentor President and CEO Joshua Levine said, "We're very gratified that the panel came to the decision they did and hopeful the agency will focus on the same things -- the quality of our science and the quality of our data on safety and efficacy." He added, "I think the panel concluded that not all breast implants are created equally and not all test methods are created equally" (Washington Post, 4/14).
Mentor officials said that the company would follow the conditions of the committee in the event FDA approved the application (New York Times, 4/14).
Dan Cohen, Inamed vice president of global government and corporate affairs, said that the company was "surprised and stunned" by the committee decision to recommend approval of the Mentor application (Wall Street Journal, 4/14). He said on Wednesday that he was "amazed by a bizarre and strange decision by a few panel members who yesterday demanded longer-term safety data and today accepted shorter-term data" (New York Times, 4/14).
Inamed President and CEO Nicholas Teti on Wednesday in a statement said, "Inamed views the panel decision as curious and inconsistent with the decision reached by the panel yesterday on Inamed's (application) -- we look forward to working with ... FDA staff on addressing these inconsistencies" (Washington Post, 4/14).
CBS' "Evening News" on Wednesday reported on the committee decision to recommend approval of the Mentor silicone breast implant application. The segment includes comments from Kimberly Hoffman, a woman who experienced a rupture in silicone breast implants manufactured by Mentor and subsequent illnesses, and Levine (Attkisson, "Evening News," CBS, 4/13). The complete segment is available online in RealPlayer.
In addition, NPR's "All Things Considered" reported on the committee recommendation (Silberner, "All Things Considered," NPR, 4/13). The complete segment is available online in RealPlayer.