Allergan Breast Implant Lawsuit: The BIOCELL Recall

The Recall

In July 2019, at the FDA’s request, Allergan announced a worldwide recall of its BIOCELL textured breast implants and tissue expanders. The reason was a link to breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) — a rare cancer of the immune system (a form of non-Hodgkin lymphoma), not breast cancer. At the time, regulators had recorded hundreds of BIA-ALCL cases worldwide and a number of deaths, with the textured surface of these particular implants over-represented in the reports.

The rough, textured surface — designed to help implants stay in place — was the focus of concern, and the recall removed the affected products from the market.

The Litigation

Patients filed lawsuits alleging that Allergan knew or should have known of the elevated BIA-ALCL risk and failed to adequately warn patients and surgeons. The federal cases were consolidated into a multidistrict litigation in the District of New Jersey. The claims include women who developed BIA-ALCL and, in some suits, those who now face the cost and anxiety of monitoring or removing recalled implants. Allergan set up a limited program to help with some costs of replacing recalled implants, but that is separate from compensation for injury.

At the time of writing there was no global settlement; the litigation remained active.

What Patients Should Know

If you have breast implants, ask your surgeon whether they are the recalled BIOCELL textured type, and learn the symptoms of BIA-ALCL — often swelling or fluid buildup around an implant years after surgery, which is usually treatable when caught early. Health authorities generally do not recommend removing recalled implants that are not causing symptoms; discuss the right approach with your doctor. Keep your implant cards and surgical records.