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June 22, 2011

FDA Should Have Advised Women Against Getting Silicone Breast Implants for Cosmetic Reasons

Statement of Dr. Sidney Wolfe, Director, Public Citizen’s Health Research Group

The Food and Drug Administration’s (FDA) update today stating that although silicone breast implants have “a reasonable assurance of safety … the longer a woman has breast implants, the more likely she is to experience local complications or adverse outcomes,” is unquestionably shortsighted as well as contradictory.

Public Citizen continues to oppose the FDA’s 2006 decision to return silicone breast implants to the market for cosmetic use in women for augmentation.

The agency’s newer information about the risk of implant-associated lymphoma and the previously known risks are serious enough to warrant advising women against having these implanted.

The deliberate effort of the two largest plastic surgical organizations to encourage their members to mislead women about the cancer risk, documented in the URLs below, makes it unlikely that, for many women, the FDA mantra that “the benefits and risks of breast implants are sufficiently well understood for women to make informed decisions about their use,” and that “manufacturers and physicians should continue to provide balanced and up-to-date information to women considering breast implants to help inform their decisions,” will be a reality.

Although there are many excellent and ethical plastic surgeons, the fact that many have been informed by their own organizations to downplay the risks of breast implants is incompatible with adequate informed consent for too many women. The FDA’s acknowledged inadequacy of implant company safety studies makes their continued use resemble an experiment on women, rather than a product with “a reasonable assurance of safety.”

Public Citizen first petitioned the FDA in 1988 to ban silicone breast implants because they caused highly malignant cancer in animals tested.

To read about how plastic surgery associations directed their members to mislead patients about the cancer risk of implants, visit: http://www.citizen.org/pressroom/pressroomredirect.cfm?ID=3276 and http://www.citizen.org/pressroom/pressroomredirect.cfm?ID=3285.

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