Important Notice: Avoid Using BioZorb Marker Implantable Radiographic Marker Devices – FDA Safety Advisory

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Date Issued: October 25, 2024

The U.S. Food and Drug Administration (FDA) alerts consumers, healthcare providers, and health facilities about the potential dangers associated with BioZorb Markers and BioZorb LP Markers manufactured by Hologic Inc.

On October 25, 2024, Hologic announced a voluntary recall of all unused BioZorb Markers following reports of serious adverse events in patients with implanted devices in breast tissue.

This communiqué is intended to inform you about the latest recall notice from the manufacturer and the recommended next steps.

Patient and Caregiver Recommendations

• Contact your healthcare provider immediately if you experience any adverse effects from the BioZorb Marker.
• Removal of the device is not necessary unless instructed by your healthcare provider.
• Discuss possible risks with your provider if you are undergoing radiation therapy. The FDA has not approved BioZorb Marker for radiation treatment.
• Report any issues regarding your BioZorb Marker to the FDA.

Guidelines for Healthcare Providers and Facilities

• Do not implant BioZorb Markers.
• Isolate and return all unused BioZorb Markers to Hologic.
• Review the recommendations for patients with BioZorb Markers with your patients.
• Stay informed on reports of serious adverse events related to BioZorb Markers.
• Monitor patients with implanted BioZorb Markers for any adverse signs.
• Remember, the FDA has not approved the use of BioZorb Markers for enhancing cosmetic results or for initial marking for radiation treatment.
• Report any patient complications to the FDA.

Device Overview

BioZorb Markers are implantable devices for use in soft tissue, including breast tissue. They consist of a dissolvable plastic component and a permanent titanium component.

The intended use of BioZorb Markers is for the radiographic marking of soft tissue sites. However, they are not indicated for enhancing cosmetic results, filling tissue space, or serving as a marker during radiation therapy.

Associated Risks with BioZorb Markers

Complications reported with BioZorb Markers include:

• Pain
• Infection
• Rash
• Device migration
• Device erosion
• Seroma
• Discomfort
• Other complications related to the presence of the device in the breast

Some patients required additional medical intervention, including device removal.

FDA Oversight

The FDA will continue collaborating with Hologic to monitor ongoing issues related to BioZorb Markers and keep the public updated with any significant developments.