Hologic Has a Serious Recall of the BioZorb Marker

The U.S. Food and Drug Administration (FDA) has deemed Hologic’s recall of its BioZorb Marker due to implanted device complications as Class I, the most serious type of recall.
 
Hologic recalled the BioZorb Markers distributed from April 29, 2019 to April 1, 2024 because of complications and events reported with implanted devices. Complaints included reports of pain, infection, rash, device migration, device erosion, seroma, discomfort, or other complications from feeling the device in the breast. Additional medical treatment was also needed to remove the device.
 
In its March 13, 2024 Important Medical Device Safety Notification, Hologic urged patients to contact their healthcare provider if they have adverse events after BioZorb Market placement. The company also recommended discussing benefits and possible risks of implantable breast tissue markers for breast cancer procedures with their healthcare provider.
 
Healthcare providers were requested to inform all patients on which device will be used if a marking device will be utilized during breast conservation surgery. They should continue to mionitor patients who have an implanted BioZorb marker for signs of adverse events and report problems or complications that patients experience following the device’s placement.
 
So far, Hologic has received reports of 71 injuries related to the recall, with no deaths. The company advised that the recall is a correction, not a product removal.

More about the BioZorb Marker

The BioZorb Marker is an implantable, radiographic marker with a spiral framework to mark soft tissue—such as breast tissue—for future medical procedures like radiation.
 
It has two components: a permanent titanium metal component and resorbable plastic component that resorbs over time. Provided sterile, the BioZorb Marker is meant for one-time use.
 
Hologic acquired the technology from Focal Therapeutics in a $125 million deal in 2018.