The Judicial Panel on Multidistrict Litigation sent four proposed class action lawsuits accusing Allergan of hiding rare cancer risks associated with its textured breast implants to New Jersey federal court, where the company is located and where significant evidence and witness are, the panel said.
The lawsuits claim that the medical device manufacturer didn’t alert the Food and Drug Administration (FDA) about the risk for a rare type of blood cancer associated with its Biocell textured implants until 2017, when the agency stiffened its requirements.
In July, Allergan issued a global recall of its Biocell breast implants and tissue expanders after the FDA boldly called on the company to recall its implants in the U.S. due to the risk of breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL. The FDA said it had identified 573 cases of cancer worldwide in women who had received breast implants, including 33 deaths. Among the cases, 481 were Allergan implants and, among the 33 deaths, only 13 had reported the type of implant used and all but one were Allergan implants.
Allergan went into the breast implant business in 2006, when it purchased Inamed. Inamed had been conducting a long-term safety study on its implants since 2000. The plaintiffs allege that by 2011, Allergan knew its textured implants were associated with BIA-ALCL, but refused to inform federal authorities or the public, as required by law.
The lawsuits are calling for the company to provide medical monitoring for BIA-ALCL and other breast implant-related diseases. The women are also asking for compensation to cover medical costs associated with cancer treatments and revision surgery to replace their current implants with another Allergan implant.