FDA update
U.S. Food and Drug Administration (FDA)

FDA Issues Safety Communication for Use of BioZorb Markers in Breast Tissue

On February 27, 2024, the U.S. Food and Drug Administration (FDA) issued a safety communication to patients and healthcare providers about the potential risk for serious complications with BioZorb Marker and BioZorb LP Marker devices by Hologic, Inc., which are implanted in soft tissue, including breast tissue, to mark a site for medical procedures (e.g., radiation therapy for breast cancer treatment).

February 28, 2024