BioZorb Breast Implant Marker: Class 1 Recall

Publish Date : 10/28/2024

The FDA has issued a safety communication advising against the use of BioZorb Markers, manufactured by Hologic Inc., after the company recalled all unused lots of the device on October 25, 2024. The recall follows reports of serious complications in patients who had the devices implanted in breast tissue. BioZorb Markers are used to mark soft tissue sites for future procedures but are not FDA-approved for improving cosmetic outcomes or as markers for radiation therapy.

BioZorb Markers are implantable devices used in soft tissue sites, including breast tissue. BioZorb Markers have two parts: a plastic component that is intended to be dissolved completely in the patient’s body in one year or longer, and a titanium metal component that is permanent.

For patients with implanted BioZorb Markers, the FDA recommends consulting healthcare providers about any complications but states removal is not necessary unless advised by a physician. Health care providers are urged to avoid implanting BioZorb Markers, quarantine any unused devices, and monitor patients for potential complications such as pain, infection, device migration, and skin erosion.