Hologic Breast Care Device Recall: 252 Injuries and Patient Lawsuits

Hologic, a leading mammography vendor, has been in the spotlight after the U.S. Food and Drug Administration issued a recall for certain breast care devices due to 252 reported injuries. This recall affects the BioZorb and BioZorb LP markers, which are typically implanted in soft tissue to guide radiographic procedures. The reported injuries include discomfort, infection, pain, rash, fluid buildup, and other complications associated with these markers.

In response to the recall, over 100 patients have initiated lawsuits against Hologic, with individuals citing issues such as device migration, pain, swelling, and scar tissue formation. The BioZorb device, initially produced by Focal Therapeutics, is designed for radiographic marking of soft tissue, often used in breast cancer procedures. The device consists of titanium marker clips that are meant to remain in place as permanent indicators after the bioabsorbable spacer material is resorbed by the body.

One of the plaintiffs, Mindy Holcomb, underwent a lumpectomy and partial mastectomy and experienced complications related to the BioZorb implant. Similarly, Laura Nudel, another plaintiff, reported severe pain and discomfort following a lumpectomy where the BioZorb was implanted.

Hologic, in its annual report submitted to the Securities Exchange Commission, revealed that it has been dealing with lawsuits related to the BioZorb product since 2022, estimating approximately 100 plaintiffs involved in the legal battles. The company emphasized that while it is prepared to defend its position vigorously, litigation can be unpredictable and costly.

The FDA has issued a Class 1 recall for the BioZorb product, indicating that continued use could lead to serious injury or death. The agency has urged radiologists, radiation oncologists, and facilities to discontinue the use of these markers, quarantine existing products, and report any adverse events or patient complaints.

As investigations and lawsuits continue, Hologic faces a complex legal and regulatory landscape concerning the BioZorb product line. The company must navigate these challenges while prioritizing patient safety and regulatory compliance.