This article has been updated with comments from Allergan.
Textured breast implants have been linked to BIA-ALCL, a type of non-Hodgkin’s lymphoma. The FDA asked Allergan to recall its Biocell textured implants in July 2019. Five months earlier, the agency said it had received reports of 457 unique cases of BIA-ALCL related to breast implants since 2010, including nine patient deaths.
In a recall letter sent to patients, Allergan offered to replace the textured implants with non-textured ones at no cost, according to an emergency memorandum the women filed Saturday in New Jersey federal court as part of their class action against Allergan. The recall letter does not advise class members or their surgeons of the need to sign a release to get the benefits of Allergan’s warranty coverage, inform them of the class action, or of their rights to pursue additional claims for damages against Allergan, the memorandum says.
The women asked the court to order Allergan to stop asking women seeking reimbursement to release the company from liability and to prevent the company from using those releases to protect itself.
“Patient safety is a priority for Allergan and we are committed to ensuring the safe and effective use of our products,” Allergan said in an email to MassDevice. “The motion filed Saturday contains many factual misrepresentations about Allergan’s breast implant warranty programs. As one example, contrary to plaintiffs’ core assertion, Allergan’s Biocell Replacement Warranty does not require participants to sign a release of liability. Accordingly, there is no support for the relief requested and we believe the court should deny the motion.”