Allergan BIOCELL® Breast Implants Linked to Cancer
Allergan has announced a global recall of their BIOCELL® textured breast implants and tissue expanders that have been linked to a rare cancer. The worldwide recall was initiated at the request of the U.S. Food and Drug Administration due to reports from women who have developed anaplastic large cell lymphoma, likely from implants. According to the FDA, there have been 573 cases of anaplastic large cell lymphoma associated with textured implants and 33 deaths. The agency reported that 481 of the cases were attributed to implants manufactured by Allergen.
News reports indicate the FDA had been concerned about the implants since 2011. According to the FDA statement, the FDA asked Allergan to recall the BIOCELL® textured implant “once evidence indicated that a specific manufacturer’s product appeared to be directly linked to significant patient harm, including death.”
“Based on new data, our team concluded that action is necessary at this time to protect the public health,” said FDA Principal Deputy Commissioner Amy Abernethy.
Nearly 314,000 women in the United States received breast implants in 2018, according to the American Society of Plastic Surgeons. The Society of Plastic surgeons does not distinguish between textured and smooth, but surgeons have shared that approximately five percent of U.S. women with implants received textured implants and are at risk.
Whether it is the texturing directly causing the cancer or if there is simply a higher incidence associated is being considered. Medical experts are considering whether lymphoma develops as the body generates an immune response to the textured surface interacting with surrounding scar tissue. The FDA has advised consumers not to have asymptomatic textured implants removed but to follow up with healthcare providers. All healthcare providers have been instructed to no longer implant the BIOCELL® implants and return unused products.
Martin & Jones attorneys are currently reviewing breast implant injury cases from all 50 states. If you or somebody you know has been implanted with textured silicone breast implants and has been diagnosed with lymphoma or cancer, please contact our firm immediately for a free consultation.