A Colorado woman who developed a rare form of cancer linked to her breast implants is suing Allergan Inc., the maker of the breast implants, alleging the company knew for more than a decade that its silicone-filled breast implants were linked to anaplastic large cell lymphoma, or BIA-ALCL, but failed to warn women or their doctors of this risk, Law360 reported.
The lawsuit was filed by Kendra Poniatowski, who claims that she underwent a breast augmentation in 2010. Sometime later, her right breast became swollen and painful. In 2017, she was diagnosed with early stage BIA-ALCL and her implants were removed. Poniatowski claims in her lawsuit that had she known the risks associated with Allergan’s breast implants, she would not have had the company’s products implanted in her body.
According to the lawsuit, Allergan did not fully reveal to the FDA information about the implants’ performance or whether they contributed to patient injuries. The company also failed to report manufacturing deficiencies such as improper testing and issues with the sterilization of its implants and gels. Instead, Allergan aggressively promoted its implants, essentially dismissing emerging evidence that linked breast implants to BIA-ALCL.
Poniatowski’s lawsuit comes four months after the FDA issued a Safety Communication that it had received more reports of BIA-ALCL, and advised women considering getting the implants to weigh the risks and benefits. The agency also cautioned doctors to be aware of the risk of BIA-ALCL in patients with breast implants. Women who had implants were advised to consult with their doctors if they have any BIA-ALCL symptoms, such as pain or swelling around the implant.
According to the February 2019 announcement, the agency conducted a thorough analysis of adverse events with breast implants and determined than it had received 457 cases of BIA-ALCL, including nine patient deaths.
Beasley Allen investigates claims related to defective medical devices. If you feel you may have a case related to breast implants and BIA-ALCL, contact Melissa Prickett, a lawyer in our Mass Torts Section.