Public Citizen Opposes FDA on Silicone Breast Implants

The group Public Citizen is blasting the U.S. Food & Drug Administration (FDA) for giving <"">silicone breast implants its seal of approval last week, citing the devices’ association with a variety of complications, including a rare type of lymphoma. In a statement, the consumer advocacy group said it continues to oppose the FDA’s 2006 decision to allow silicone gel breast implants to return to the market, and has advised women not to have them implanted.

In a safety update issued last week, the FDA said silicone gel implants have a “reasonable assurance of safety.” At the same time, the agency acknowledged that the longer a woman has the implants, the more likely it is that she will experience a complication that requires that they be removed or replaced. Possible complications include tightening of the area around the implant (capsular contracture), additional surgeries, and implant removal. Other complications include a tear or hole in the outer shell (implant rupture), wrinkling, uneven appearance (asymmetry), scarring, pain, and infection, the agency said.

Another possible complication is the occurrence of anaplastic large cell lymphoma or ALCL. Earlier this year, the FDA warned that 60 cases of the rare cancer have been reported among the 5 to 10 million patients with both silicone and saline breast implants. The disease – which is not breast cancer – normally occurs in the breast in only 3 in 100 million women.

At one time, silicone breast implants had been banned by the FDA for augmentation use after concerns were raised about their safety risks. They were reapproved in 2006, but the agency required the manufacturers of the devices to conduct more studies to assess their long-term safety. The FDA’s latest silicone breast implant update was based on preliminary results of these studies, which involved 40,000 women

In a statement issued last week, Public Citizen called the FDA’s endorsement of silicone breast implants shortsighted and contradictory. “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,’” the statement said.

Public Citizen also pointed to a webinar sponsored by the American Society of Plastic Surgeons (ASPS) and the American Society for Aesthetic Plastic Surgery (ASAPS) that appears to encourage doctors to downplay the association between ALCL and breast implants. As we reported previously, the groups removed the webinar from their sites after they were contacted by the FDA. But in its most recent statement, Public Citizen said the efforts of the medical groups 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.”

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