How does a company recall breast implants? The complaint for this class action alleges that Allergan, Inc., Allergan USA, Inc., and Allergan plc have recalled certain of their Biocell implants but that they are not offering surgical fees for replacement of implants already installed in women’s bodies.
The Nationwide Class for this action is all persons in the US who have been implanted with Biocell saline- or silicone-filled breast implants or tissue expanders that have been recalled by the Food and Drug Administration (FDA). State subclasses have also been proposed.
Allergan makes saline- and silicone-filled breast implants and tissue expanders. In 2019, the FDA asked for a recall, which Allergan issued on July 24. The recall was based, the complaint says, on “new information that Allergan’s BIOCELL implants were tied to a vast majority of cases of breast implant-associated anaplastic large cell lymphoma (‘BIA-ALCL’) not seen with other textured implants.” In connection with that recall, “Allergan announced that BIOCELL would no longer be sold or distributed in any market.”
BIA-ALCL is a type of non-Hodgkin’s lymphoma, that is, a cancer of the immune system. The FDA had found 573 cases of BIA-ALCL throughout the world, with 33 deaths. The risk of developing the disease appeared to be about six times higher with the Biocell textured implants than with other textured implants from US manufacturers. The FDA called the recall a “Class I recall, the most serious type of recall” and said that “use of these devices may casue serious injury or death.”
A long list of the specific products recalled can be found on pages 3 through 5 of the complaint, linked below.
On July 30, 2019, a few days after the recall, Allergan sent a letter to their plastic surgery customers. The letter said, in part, that customers who choose to replace their Biocell textured implants with smooth devices would be given smooth replacements for free during a period of twenty-four months. However, the letter also said, “As part of this program, Allergan will not provide surgical fee assistance to revision patients.”
The letter said that decision was “in-line with the FDA’s recommendation not to remove” implants from patients who did not have symptoms of BIA-ALCL because the risks were low. It said that patients who keep their implants will continue to be covered by a warranty that offers $1,000 in diagnostic fees and up to $7,500 in surgical fees for diagnosing and treating BIA-ALCL.
The complaint claims that the refusal to provide surgical fees for implant removal and the limited reimbursement for costs if BIA-ALCL occurs are insufficient.
The complaint also claims that Allergan submitted adverse incident reports with incorrect manufacturer names to hide problems with their implants. It alleges that Allergan had “insufficient follow-up rates and inadequate data” in its post-market compliance, in violation of its legal duties.