FDA Links 9 Deaths to a Rare Cancer Associated with Breast Implants
A rare type of cancer believed to be caused by breast implants has now been linked to nine deaths. The Food and Drug Administration released an update on Tuesday to a 2011 report about a rare form of cancer called anaplastic large cell lymphoma (ALCL), which is not linked to breast cancer. The agency’s original report stated that this rare form of cancer is believed to be caused by breast implants and is not related or associated with cancer of the breast tissue. Now, six years later, the FDA says they have gathered more information that links nine deaths to anaplastic large cell lymphoma, which its findings have proved is caused by textured implants.
According to the statement, the FDA received 359 reports concerning breast implants and ALCL—included in the reports were nine deaths. Of those reports, 231 included information about the surface of the implants; 203 were textured implants and 28 had a smooth surface. From the data collected, the agency suggests that breast implant–associated anaplastic large cell lymphoma occurs more frequently with breast implants that have textured surfaces rather than those with smooth surfaces.
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According to Old Lyme, CT, plastic surgeon Vinod Pathy, MD, although having breast implants with a textured surface may appear to carry an increased risk for developing this disease, incidents are still uncommon. “While this rare form of cancer appears to occur in patients having breast implants with textured outer surfaces, the occurrence remains exceptionally rare,” says Dr. Pathy. “Additionally, not every textured implant is equivalent, and our national society, the American Society of Plastic Surgeons, continues to monitor the data so that information is not misinterpreted.”
Dr. Pathy says the benefits of using textured implants are twofold: “Textured implants, with their more rough surface, were developed to help limit the chance of excessive scar tissue around the implant, a complication called a capsular contracture that can make them misshapen and hard. The greater benefit with the textured implants, though, may be in their ability to remain relatively more fixed in place because the surrounding tissues can grab onto their implant surface, which can be useful with teardrop-shaped implants.”
The report does not pinpoint why textured implants carry a greater risk of developing this rare form of cancer, but plastic surgeon and researcher at the University of Southern California’s Keck School of Medicine, Dr. Alex K. Wong, told the New York Times that the body reacts differently to textured implants. “When we take these out, you can hear a peeling sound,” said Dr. Wong. “Whereas with a smooth implant, it’s like Jell-O. You can spin it around. It moves really easily.”
The FDA says it will continue to monitor and collect information about the disease, and encourages health care providers to regularly monitor patients with implants. Dr. Pathy doesn’t believe textured implants should totally be avoided at this time. “Avoidance of a textured implant altogether is not supported by the current data or studies,” he says. “There are several factors that are important in choosing a breast implant, whether for aesthetic or reconstructive purposes, and your plastic surgeon should assist you in sifting through all of the options available.”