BioZorb Marker Settlement Reached To Resolve Lawsuits Over Recalled Breast Marker

Judge indicates the global BioZorb settlement will resolve all pending lawsuits over the recalled tissue marker, though no details about the average payouts or terms of the agreement have been publicly released.

Court records indicate that parties involved in BioZorb tissue marker lawsuits have reached a global settlement that will resolve hundreds of claims alleging that the recalled breast implant was defectively designed, leading to injuries, cancer scares and additional surgeries.

The BioZorb was a surgical tissue marker made of biodegradable polylactic acid on a framework with six titanium clips. Designed by Hologic Inc., the implant was meant to assist surgeons and radiologists in identifying areas of the breast previously treated with radiation as part of breast cancer treatment.

Hologic claimed that the implant would gradually dissolve into the body, leaving only the titanium clips behind to serve as markers for previous radiation treatments. However, in May 2024 the U.S. Food and Drug Administration (FDA) announced a BioZorb marker recall, following adverse reports from women complaining of extremely painful complications, indicating the devices failed to dissolve properly, leading to implant migration, infections and other problems.

Following the recall, about 200 BioZorb marker lawsuits were filed by women who allege that the company placed profits over patients’ safety by failing to adequately warn doctors and patients about the true potential risks associated with the implant. Plaintiffs argued that Hologic knew or should have known the tissue marker could fail to dissolve properly, causing serious injuries that often require the BioZorb to be surgically removed.

All of the BioZorb lawsuits were filed in the U.S. District Court for the District of Massachusetts, where Hologic is headquartered, and placed under the purview of U.S. District Judge Allison Burroughs, who has overseen the litigation through coordinated discovery and pretrial proceedings.

In an effort to resolve the litigation swiftly, Judge Burroughs had ordered the parties to prepare for a series of bellwether early test trials, designed to gauge juries’ reactions to evidence and testimony that would have likely been repeated in hundreds of claims. The first trial was expected to begin on January 20, 2026, involving claims brought by Kimberly Taylor. A second bellwether trial was then slated for February 23, with others following on March 30 and April 27, 2026.

However, in November Judge Burroughs announced a stay in the litigation, with the pause lasting through the previously scheduled first trial date. This led to speculation that a BioZorb settlement agreement may be on the horizon.

Judge Burroughs confirmed the settlement in a court order (PDF) issued on February 3, announcing a common benefit fund for the attorneys’ fees. While no details about terms of the settlement or the average BioZorb lawsuit payout amounts women may receive have been announced, the judge indicated that lawyers appointed to various leadership positions will receive 10% of the amount awarded to plaintiffs, taken out of the attorneys fees charged.

The order also announced the selection of a Qualified Settlement Fund Administrator and a special master who will review common benefit fund applications, stating that “the litigation is effectively concluded.”