Hologic BioZorb Marker Recall Identified as Class I

Hologic’s recall of its BioZorb Markers due to complications with the implanted device were recently identified as Class I by FDA after 71 injuries were reported as being related to BioZorb Markers. The recall is considered a correction, not a product removal.

The BioZorb marker, which was previously made by Focal Therapeutics, is an implantable radiographic marker used to mark soft tissue, like breast tissue, for future medical procedures like radiation. The device includes two components: a permanent component made of titanium and a resorbable component made of a plastic material. Meant for one-time use, BioZorb is provided sterile for implantation.

Hologic announced the recall after reports of complications and adverse events (AEs) connected to the implanted devices. Such complaints included pain, infection, rash, device migration, device erosion, seroma, discomfort, feeling the device in the breast, and the need for additional medical treatment to remove the device. Currently, there have been no reports of death associated with the recall.

On March 13, Hologic sent all affected customers an Important Medical Device Safety Notification requesting that patients contact a healthcare provider if they experience any adverse events following the placement of a BioZorb marker and discuss the risks and benefits of implanting the device. The letter also requested that healthcare providers be aware of any reported serious AEs following BioZorb Marker implantation, to continue monitoring patients who have the implants, and report any issues associated with the device.

This is just the latest chapter in an ongoing saga of issues concerning the Hologic BioZorb markers in 2024. In February, FDA announced through a safety communication that it was advising patients and healthcare providers to be aware of potential risks of serious complications when using the BioZorb Marker and BioZorb LP Marker devices. In the communication, the agency highlighted reports and published literature describing SAEs in patients who were implanted with the device in breast tissue.

At the time of the notice, FDA wrote that it had received reports of SAEs in patients undergoing breast conservation procedures like lumpectomy. These complications, in part, could be related to the BioZorb Makers extended resorption time of several years, according to FDA. Additionally, it was reported that similar AEs were seen in literature, including the device breaking through the skin of the nipple and moving out of position from where it was initially implanted. Consequences of such migration could lead to potential breakthrough of the chest cavity or blood vessels, which could be life-threatening and impact future targeting of radiation to the intended site.

"Hologic and the FDA issued a safety notification in February to help ensure patients and healthcare providers had the most up-to-date information regarding BioZorb," a Hologic spokesperson told MD+DI. "The recent administrative classification of the Safety Notification posted on the FDA’s website was an expected step in the regulatory process. BioZorb continues to be offered and used safely and successfully with patients undergoing radiation treatment following breast conserving surgery. Patient safety is, and has always been, our top priority."