Science, Politics in FDA Decision Not To Allow Market Reentry of Silicone Breast Implants Examined
The Baltimore Sun on Monday examined the debate over the science and politics in the FDA decision last week not to allow market reentry of silicone breast implants (Niedowski, Baltimore Sun, 1/12). 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 the company must conduct additional research to prove the efficacy and safety of 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, 1/9). According to the Sun, although several studies have found no link between silicone breast implants and cancer and autoimmune diseases such as lupus and rheumatoid arthritis, opponents of market reentry for the implants have raised concerns about other health risks related to potential ruptures or leaks. However, supporters of market reentry of silicone breast implants maintain that most FDA-approved products have some health risks and "wonder whether any amount of data will satisfy the agency against a backdrop of public skepticism" about widespread use of the implants, the Sun reports.
Nora Jacobsen, a public health sciences professor at the University of Toronto, said, "The science is political. If you look at the things the FDA considers in making decisions, values are part of the way those decisions are made and (part of) the way you weigh certain risks and benefits." Dr. Sheri Slezak, an associate professor of plastic surgery at the University of Maryland School of Medicine, said, "I thought the decision in '92 was totally political," adding, "People emotionally and fervently believe in whatever side they are on." Marcia Angell, senior lecturer on social medicine at Harvard Medical School and former editor of the New England Journal of Medicine, said, "I find it a little paternalistic that the FDA, which I think is perhaps not fastidious enough about drugs and other devices, is so very fastidious about this device" (Baltimore Sun, 1/12).
The "scaremongers win again" as a result of the FDA decision not to allow market reentry of silicone breast implants, according to a Wall Street Journal editorial. The FDA decision is an "unhappy surprise" because "study after study has failed to substantiate" claims that silicone breast implants "were poisoning women to death, causing systemic diseases such as cancer and autoimmune disorders," the editorial states. The FDA, which made the decision "in the midst of a media/trial lawyer-driven hysteria," is "holding silicone implants to ever higher and shifting standards," the editorial continues. The FDA should have allowed market reentry of silicone breast implants and required Inamed to maintain a registry of women who receive them to track their health and provide long-term information, according to the Journal. However, "instead of going with science here, the FDA has sided with the fears," the editorial states, adding that the agency should "stop moving the goalposts" (Wall Street Journal, 1/13).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.