FDA announces class 1 recall for radiographic breast tissue marker

Editor's Note

The US Food and Drug Administration (FDA) has designated the recall of Hologic Inc.’s BioZorb Marker a class 1, indicating a risk of serious injury or death.

BioZorb is an implantable radiographic marker used to mark soft tissue (such as breast tissue) for future medical procedures. Provided sterile and meant for one-time use, the device combines a permanent titanium component with plastic material that reabsorbs over time. According to the May 22 announcement, reasons for the recall include reports of pain, infection, rash, device migration, device erosion, seroma, discomfort, and other complications from feeling the device in the breast, as well as the need for additional medical treatment to remove the device. 

FDA reports 71 injuries and no deaths related to these products. In a March 13 letter to patients and providers, Hologic warned affected parties to discuss the benefits and possible risks of implantable breast tissue markers for cancer procedures and to submit complaints to [email protected] and to the FDA’s MedWatch Adverse Event Reporting program.