BioZorb — previously made by Focal Therapeutics, which Hologic bought out in 2018 — is an implantable radiographic marker used to mark soft tissue (such as breast tissue) for future medical procedures, such as radiation. It features two components. One, a permanent component, is made of titanium metal. The other is a resorbable component made of a plastic material that resorbs over time. The company designed it as a sterile device for one-time use.
Hologic recalled the marker due to complications and adverse events reported with implanted devices. The recall is a correction, not a product removal.
Complaints included reports of pain, infection, rash, device migration, device erosion, seroma, discomfort or other complications from feeling the device in the breast. The company received reports of the need for additional medical treatment to remove the device as well.
To date, Hologic has received 71 reports of injuries and zero reports of death, according to an FDA notice.
Hologic’s recall extends to nine models of the BioZorb device distributed between April 29, 2019, and April 1, 2024. The company initiated the recall, which affected 53,492 total devices, on March 14, 2023.
In a letter to affected customers, the company requested that patients contact providers if they experience adverse events following BioZorb placement. They should also discuss the benefits and possible risks of the devices with their healthcare provider.
Hologic statement
A Hologic spokesperson shared the following statement with MassDevice via email:
“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. 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.”
