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Public Citizen, a consumer watchdog group, indicates that the FDA did not go far enough in warning women about the risks associated with silicone breast implants last week, suggesting that women should be advised against having the implants.
Last week, on June 22, the FDA issued new safety data for silicone breast implants, indicating that the agency has found no link between the breast implants and breast cancer.
Although the agency said that the silicone implants have a “reasonable assurance of safety”, they also indidicated that “the longer a woman has (silicone) breast implants, the more likely she is to experience local complications or adverse outcomes.”
In a statement released last week, Public Citizen called the agency’s stance shortsighted and contradictory.
The FDA has acknowledged that while there appears to be no link to breast cancer, there are other common side effects and complications with silicone breast implants, such as ruptures, scarring, tightening of the skin around the implant, pain and infections. Despite these problems, the agency has determined that silicone implants are safe and effective when used properly, but the FDA is continuing to gather data.
In 2006, the FDA allowed silicone gel-filled breast implants to return to the market after having requiring a silicone breast implant recall in 1992 due to a failure by manufacturers, Allergan and Mentor Corp., to turn over requested clinical trial data and suspicions that the implants could cause breast cancer. The FDA’s subsequent studies found no links to breast cancer and the manufacturers turned over preliminary trial data, paving the way for their return to the market.
Breast implant manufacturers have complained that they have had trouble keeping women enrolled in silicone breast implant studies, and last week the FDA urged women to remain a part of those studies so that the effects of silicone breast implants over long-term use could be better understood.
Public Citizen has opposed the re-approval of silicone breast implants, arguing that the FDA’s lack of data and the reliance on post-marketing observation of women who have received breast implants makes the return of silicone breast implants to the market resemble an experiment on women. The group also pointed out that the report comes just months after the FDA warned that both silicone and saline breast implants could be linked to lymphoma.
In January, the FDA also warned that both silicone and saline breast implants may be linked to a form of cancer known as anaplastic large cell lymphoma (ALCL). While it can form in the breasts, it is not considered breast cancer. Shortly after the FDA issued the warning, the American Society of Plastic Surgeons (ASPS) and the American Society for Aesthetic Plastic Surgery (ASAPS) put up an online video, called a webinar, that appeared to many critics to be urging plastic surgeons to downplay the FDA warning and avoid using the word cancer.
A concerned plastic surgeon sent Public Citizen a transcript of the webinar, during which ASPS President Dr. Phil Haeck said plastic surgeons were justified in “downplaying” the malignant potential of ALCL tumors. The webinar also instructed plastic surgeons to tell patients that cancer surgery was curative, which Public Citizen says is inaccurate. Public Citizen expressed concerns and called on the FDA to take action. The information was taken down after the FDA contacted the two groups.
Public Citizen said that the incident highlights concerns that women who participate in studies or receive breast implants may not be adequately educated enough to provide informed consent.