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# Alert Issued on Hologic’s BioZorb Markers
- URL: https://www.fdaweb.com/alert-issued-on-hologics-biozorb-markers/
- Published: 2024-02-27T12:00:00.000Z
- Updated: 2026-09-14T14:23:56.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5156438

An FDA [safety alert](https://www.fda.gov/medical-devices/safety-communications/biozorb-markers-and-potential-risks-use-breast-tissue-fda-safety-communication?utm%5Fmedium=email&utm%5Fsource=govdelivery) is warning patients and healthcare providers about the potential risk of serious complications with Holigic’s BioZorb Marker and BioZorb LP Marker devices, which are implanted in soft tissue (e.g., breast tissue) where the site needs to be marked for future medical procedures, such as breast cancer radiation.

FDA says the alert is based on reports that describe adverse events with use of the devices in breast tissue, including infection, fluid buildup, device migration, device erosion and breaking through the skin, pain, discomfort, rash, and other complications possibly associated with extended resorption time (resorbable component of the device not resorbing in the patient’s body for several years). The agency also says it is aware of literature reports describing similar adverse events including the device breaking through the skin of the nipple and the device moving out of position from where it was implanted.

The alert advises healthcare professionals to monitor patients who have an implanted BioZorb Marker or BioZorb LP Marker for signs of any adverse events.