FDA Decides Not To Allow Market Reentry of Silicone Breast Implants, Requests Additional Study
The FDA on Thursday rejected the recommendation of an advisory committee to allow market reentry for silicone breast implants manufactured by California-based Inamed and said that "more research was necessary to prove their safety," the Los Angeles Times reports (Kemper, Los Angeles Times, 1/9). In October, an FDA advisory panel voted 9-6 in favor of market reentry for silicone breast implants after a two-day hearing that included testimony from 107 witnesses, such as researchers, Inamed officials and patients who had received the 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. Under current FDA rules, only women who seek breast enlargement or reconstruction surgery as part of clinical trials can receive silicone breast implants (California Healthline, 10/16/03). The FDA sent Inamed officials a "non-approval" letter for their application to market silicone breast implants for widespread use. According to Dr. David Feigal, chief regulator of medical devices for the FDA, the letter is "not a final action," and the Inamed application "is still under review." However, to determine the safety and efficacy of silicone breast implants, Inamed will have to conduct new studies and address additional concerns raised by the FDA, Feigal said (Los Angeles Times, 1/9). Although "a lot of information has been developed over the last 10 years that increases our assurance of the safety" of silicone breast implants, "there is additional information that we think is necessary for this product to pass the threshold of what we would consider necessary," Feigal said (Kolata, New York Times, 1/9). He added, "It's important that people who decide to use these products know how they perform. And it's important that women who have complications understand what they can expect" (Kaufman, Washington Post, 1/9).
The FDA has asked Inamed to conduct "rigorous mechanical tests under conditions more similar to those in a woman's body" to determine the safety and efficacy of silicone breast implants, the Los Angeles Times reports. According to Dan Cohen, vice president for global government affairs for Inamed, the company has not conducted such studies in the past (Los Angeles Times, 1/9). The FDA also requested that Inamed conduct additional studies to determine:
- The length of time that silicone breast implants last;
- Why the implants might leak or rupture;
- How women can identify leaks or ruptures in the implants;
- The effect that leaks and ruptures have on the health of women (Bell/Niedowski, Baltimore Sun, 1/9);
- The rate and forms of leaks and ruptures in the implants; and
- The treatments available to remove damaged implants (Higgins, Washington Times, 1/9).
Teti on Thursday said that Inamed considers the FDA decision "a setback, but by no means do we see this as the end of the road" (Los Angeles Times, 1/9). He added that Inamed plans to "work aggressively and cooperatively" with the FDA to receive approval for the application for market entry of silicone breast implants. Sidney Wolfe, director of the Health Research Group at Public Citizen, said, "The FDA appears to be raising the threshold of approval by requiring these companies to provide more information" (Washington Times, 1/9). He added in a statement that the decision "is a rejection of what would have been the most dangerous, defective medical device ever approved by the FDA despite advanced knowledge of its dangers" (Public Citizen release, 1/8). Cynthia Pearson, executive director of the National Women's Health Network, said that the FDA "sent a message that the current implants don't have enough safety data for women to make an informed decision, yet at the same time, they said, we want implants, but we want safe and effective implants. That's as good as it gets" (New York Times, 1/9). National Organization of Women President Kim Gandy said, "I am relieved to hear that the full FDA is taking the health of women more seriously" than the panel that recommended approval in October (NOW release, 1/8). Diana Zuckerman, president for the National Center for Policy Research for Women and Families, said that the group supports the FDA decision, adding, "Even the FDA advisers who recommended approval all agreed that we don't know the long-term safety" of the devices (USA Today, 1/9). American Society of Plastic Surgeons President Rod Rohrich said that the FDA decision was "reasonable" but would likely "delay the introduction of silicone implants in this country for several years" (Wall Street Journal, 1/9).
NPR's "All Things Considered" on Thursday reported on the FDA decision. The segment includes comments from Dr. Marcia Angell, former editor of the New England Journal of Medicine; Pearson; Dr. Daniel Schultz, director of device evaluation for the Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices at the FDA; and Wolfe (Knox, "All Things Considered," NPR, 1/8). The complete segment is available online in RealPlayer. In addition, PBS' "NewsHour with Jim Lehrer" on Thursday reported on the FDA decision. The segment includes comments from Feigal, FDA Commissioner Mark McClellan and Zuckerman ("NewsHour with Jim Lehrer," PBS, 1/8). The complete transcript of the segment is available online.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.