Allergan, Inc. has been hit in the last week with at least two more proposed class action lawsuits over the link between the company’s recalled Biocell textured breast implants and an increased risk of developing breast implant-associated anaplastic large cell lymphoma—BIA-ALCL—a cancer of the immune system.
The cases explain that BIA-ALCL, a type of non-Hodgkin’s lymphoma, is found in the scar tissue and fluid near the breast implant and can potentially spread throughout the body and become fatal. Treatment for BIA-ALCL can involve removal of the implant and surrounding scar tissue and/or chemotherapy and radiation treatment, the suits add. Symptoms of BIA-ALCL include a change in breast shape, persistent swelling, lumps in the breast or armpit, rash, pain, and redness.
The lawsuits, filed in California and New York by pseudonymous plaintiffs, echo previous cases in alleging that defendants Allergan (formerly Inamed Corporation), Allergan USA and Allergan plc knew of the increased risk of BIA-ALCL associated with their Biocell textured implants as early as 2011 yet failed to warn women who considered undergoing implantation. The complaints further charge that although Allergan’s Biocell implants were banned from sale on the European market in December 2018, the New Jersey company continued selling the products in the United States until they were recalled nationwide in July 2019 under pressure from the FDA.
Allergan, the lawsuits allege, attempted to conceal from the public and doctors the BIA-ALCL risk linked to its Biocell products in part by failing to report all adverse events to the FDA. As the suit from New York tells it, Allergan, rather than accurately inform the FDA of adverse events each time an individual injury or malfunction occurred, instead chose to “bury evidence” by reporting ruptures or BIA-ALCL instances as “routine events,” which were not required to be disclosed to the public until 2017.
The lawsuit filed in California’s Northern District alleges that despite the recall, Allergan “refuses to take full responsibility and refuses to cover the significant costs” associated with removal of its Biocell textured implants and subsequent medical monitoring. The plaintiffs in each case say they would not have chosen Allergan’s Biocell textured breast implants had they known they carried a significantly greater risk of developing BIA-ALCL, notwithstanding the costs associated with removal, medical monitoring and further procedures and treatments stemming from the illness.
A full list of the Allergan Biocell textured breast implants and tissue expanders affected by the FDA’s Class I recallcan be found here. Both lawsuits are embedded below.