Hologic BioZorb Marker Recall Identified as Class I

Hologic's recall of its BioZorb markers due to implanted device-related complications was recently identified as Class I by the FDA after 71 injuries were reported to be linked to BioZorb markers. The recall is considered a correction and not a product withdrawal.

The BioZorb Marker, previously manufactured by Focal Therapeutics, is an implantable radiographic marker used to mark soft tissues, such as breast tissue, for future medical procedures like radiation therapy. The device comprises two components: a permanent titanium component and a resorbable plastic component. Intended for single use, BioZorb is supplied sterile for implantation.

Hologic announced the recall after reports of complications and adverse events (AEs) related to the implanted devices. These complaints included pain, infection, rashes, device migration, device erosion, seroma, discomfort, sensation of the device in the breast, and need for additional medical treatment to remove the device . At this time, no deaths associated with this recall have been reported.

On March 13, Hologic sent an important medical device safety notification to all affected customers directing patients to contact a healthcare provider if they experience adverse events following placement of a BioZorb marker and discuss the risks and benefits of device implantation. The letter also requested that healthcare providers be informed of any serious AEs reported following implantation of the BioZorb Marker, continue to monitor patients with the implants, and report any problems associated with the device.

This is just the latest chapter in an ongoing saga of issues surrounding Hologic BioZorb markers in 2024. In February, the FDA announcement through safety communication informing patients and healthcare providers to be aware of the 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 received the device implanted in breast tissue.

At the time of the notice, The FDA wrote that he had received reports of SAEs in patients undergoing breast conservation procedures such as lumpectomy. These complications, in part, may be related to BioZorb Makers' prolonged absorption time of several years, according to the FDA. Additionally, similar AEs have been reported to have been observed in the literature, including the device piercing the skin of the nipple and moving out of position from where it was initially implanted. The 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 did not respond to MD+DIrequest for comment.