Allergan Biocell Breast Implants and Increased Lymphoma Risks Class Action

This class action, against Allergan, Inc., Allergan USA, Inc., and Allergan plc, takes on a serious subject. The complaint alleges that women who have Biocell textured breast implants and tissue expanders have a higher risk of breast-implant-associated anaplastic large cell lymphoma (BIA-ALCL), which is “a deadly cancer of the immune system.”

The Food and Drug Administration (FDA) received reports that Biocell implants were associated with cases of BIA-ALCL, the complaint says: “Of the 573 known cases of BIA_ALCL, 481 (or about 84%) were attributed to Allergan products, and of the 33 reported deaths, ’12 of the 13 patients for which the manufacturer of the implant is known are confirmed to have an Allergan breast implant[.]’”

A long list of implant models are contained in the complaint, which is linked below. The complaint says, “According to the FDA, the risk of BIA-ALCL is six times higher with Allergan’s textured implants than [with] textured implants from other manufacturers.”

The complaint alleges that Allergan knew of the increased risks of this disease as early as 2011, it failed to warn women about them. (Allergan was formerly known as Inamed Corporation.)

According to the complaint, “In December 2018, Allergan textured breast implants lost their European certification and subsequently were suspended from the European and Brazilian markets.”

The FDA requested that Allergan issue a recall, which Allergan announced on July 14, 2019. 

However, it seems that Allergan is unwilling to do much more than that. The complaint claims, “Allergan has refused to pay for the removal of the recalled products or any of the consequences of additional surgery that women who choose removal will have to undergo, or for medical monitoring of the substantially increased risk of BIA-ALCL that all women implanted with the devices have been subjected to.” It’s fair to wonder, then, what a “recall” means for women who are already implanted with the Biocell products.

The plaintiffs in this case are identified only by their initials. All of them have Biocell implants, and a significant proportion of them have begun to show what the complaint alleges are symptoms of BIA-ALCL, including pain, swelling, asymmetry, itchiness, and achiness in the breasts.

The Nationwide Class is all individuals in the US who implanted Biocell saline-filled or silicone-filled breast implants or tissue expanders that have been recalled by the FDA. The Calfornia Subclass is all individuals who implanted Biocell saline-filled or silicone-filled breast implants or tissue expanders that have been recalled by the FDA while in California.

Article Type: Lawsuit
Topic: Medical Devices
Tags: Cancer Risk, Defective Medical Devices, Medical Devices