A group of women is accusing breast implant manufacturer Allergan of intentionally keeping the public in the dark about the cancer risk their product poses. Six women filed lawsuits against the company for its understated label warnings regarding BIOCELL textured implants, and the plaintiffs explain other ways in which the company’s cloak-and-dagger reporting tactics put the women in harm’s way.
Specifically, the lawsuits contend that Allergan kept a tight lid on its annual status report to the U.S. Food and Drug Administration (FDA). The company shielded its report from the public, thereby preventing would-be implant recipients from making a more informed choice about their procedures. Furthermore, the plaintiffs allege that the defendant submitted other reports under code names, thereby skirting any association with their company’s products. The suits also claim that Allergan presented inaccurate medical information in its reports.
Evidence of the misinformation appears in one report, in which the writers stated that the Allergan breast implants presented “no adverse event.” This characterization contradicts another Allergen report, which points to the risk of lymphoma, but refers to it as a non-breast cancer.
In August 2019, the FDA requested that Allergan issue a voluntary recall of its BIOCELL textured breast implants and tissue expanders. The request came on the heels of newly submitted Medical Device Reports. These documents contained data connecting the BIOCELL implants with 481 breast-implant-associated anaplastic large cell lymphoma (BIA-ALCL) cases from across the globe—some proving fatal.
The FDA weighed this new data with its analysis and concluded that BIOCELL textured implant recipients suffer a risk of BIA-ALCL around six times greater than they would with other manufacturers’ implants. The agency thereby concluded that the implants cause “serious, adverse health consequences and potentially death.” Allergan complied with the FDA request, recalling more than 30 of its BIOCELL products in the summer of 2019.
Although ALCL is a relatively rare form of cancer, the FDA attributes over 80 percent of currently known cases of this cancer to various Allergan breast implants. A form of non-Hodgkin’s lymphoma, the cancer generally appears in implant-adjacent fluid and scar tissue. Although the risk of developing ALCL is low, a diagnosis can end in death, particularly in cases of late diagnosis and treatment.
The women who filed their lawsuits in state Superior Court in Morristown, NJ, last month represent only the latest plaintiffs to come after Allergan. Although none are currently diagnosed with ALCL, they are suing the implant manufacturer for the fact that the plaintiffs now suffer a greater chance of developing the cancer. The cost of removing the implants—a procedure that each plaintiff either plans to undergo or has already undergone—is hefty and will likely be included in the damages they seek. Furthermore, the suits describe the physical disfigurement and emotional pain these women have endured at the hands of a company that knew their products were dangerous—and sold them anyway.
As of February 2020, Allergan has been named as the defendant in similar lawsuits from more implant recipients from New Jersey, Massachusetts, and Florida.