FDA says Hologic recalls breast care devices after 71 injuries

BioZorb is FDA cleared for radiographic marking of soft tissue sites, including the breast. The FDA noted that it is also used to mark places where future medical procedures will be performed. However, the product is not approved for filling spaces in breast tissue or improving cosmetic results after procedures.

The agency is urging radiation oncologists and radiation oncologists to monitor patients implanted with the BioZorb marker for any signs of complications. Physicians should also discuss the potential risks of such tissue marking devices, inform patients about their implantation, and report any problems to the federal government. In the meantime, patients should contact their healthcare provider and report any problems or complications to Hologic at [email protected] and through the FDA’s MedWatch Adverse Event Reporting program.

Hologic did not immediately respond Radiology Business request for comment on Wednesday. However, the Marlborough, Massachusetts-based company issued a statement in February after the initial warning. According to the FDA, the company also issued a medical device safety alert on March 13.

“The safety of patients and healthcare providers is our top priority and we are committed to providing our customers with timely information that allows them to make informed decisions about their treatment,” the company said. “While we want to ensure that customers receive the most up-to-date and accurate information, we have full confidence in the benefits that the BioZorb marker provides for breast cancer patients, and these benefits are supported by extensive clinical literature,” he later added.

Hologic disclosed further details about the circumstances leading up to the stock withdrawal in a May 3 filing with the Securities and Exchange Commission. On November 4, 2022, a class of plaintiffs filed a product liability complaint in Massachusetts state court. Patients claim to have experienced side effects that were not disclosed in the BioZorb marker’s instructions for use, and have subsequently been subject to similar lawsuits.

So far, attorneys have filed complaints on behalf of 88 different plaintiffs, records show.

“Discovery is ongoing,” Hologic wrote on May 3. “While the Company believes it has reasonable defenses and plans to vigorously defend its position, litigation can be costly and unpredictable, and at this early stage the Company is unable to reasonably evaluate the outcome of this matter.”

BioZorb became part of Hologic’s product line following its $125 million acquisition by Focal Therapeutics in 2018. In the same SEC filing, Hologic said it recorded an impairment charge on its balance sheet in the second quarter of 2024 nearly $27 million because the BioZorb group of products is worth less than its original valuation, Hologic said.