FDA Safety Warning and Recall for BioZorb Markers

Did you know? The FDA Issued a Safety Warning and Recall for BioZorb Markers

Date Issued: October 25, 2024

The U.S. Food and Drug Administration (FDA) has issued a critical safety alert advising consumers, healthcare providers, and facilities not to use BioZorb Markers, including BioZorb LP Markers, manufactured by Hologic Inc. This comes after the manufacturer announced a voluntary recall of all unused BioZorb Markers due to reports of serious adverse events experienced by patients with these devices implanted in breast tissue.

Key Details of the Recall

Hologic’s recall aims to remove all lots of BioZorb Markers from circulation following numerous reports of complications, ranging from mild discomfort to severe medical issues requiring additional treatment. The FDA emphasizes the importance of healthcare professionals and patients understanding the risks associated with these devices and taking appropriate actions to mitigate potential harm.

Recommendations for Patients with BioZorb Markers

If you or a loved one has a BioZorb Marker implanted, here’s what you need to know:

• Monitor for Complications: Be vigilant for any pain, infection, rash, or unusual discomfort. Report symptoms to your healthcare provider immediately.
• Device Removal: Removal (explantation) is generally not necessary unless your healthcare provider advises it based on your symptoms or risks.
• Radiation Therapy Risks: Discuss any upcoming radiation treatments with your provider, as BioZorb Markers are not FDA-approved for use as radiation treatment markers.
• Report Issues: You can report any problems or complications related to your BioZorb Marker directly to the FDA.
• Call an Attorney: You should get a free consultation from a BioZorb lawsuit attorney at our office at any time. This way you can get advice on what to do.

Guidance for Healthcare Providers

If you work in a healthcare setting, follow these actions:

• Cease Use: Do not implant BioZorb Markers under any circumstances.
• Return Unused Devices: Quarantine and return all unused BioZorb Marker lots to Hologic.
• Monitor Patients: Carefully monitor patients with implanted BioZorb Markers for adverse events and address concerns promptly.
• Inform Patients: Ensure patients understand the risks, particularly if they are undergoing radiation therapy or experiencing symptoms linked to the implant.

What Are BioZorb Markers?

BioZorb Markers are radiographic implants designed to mark soft tissue sites for medical procedures. The device consists of two components:

• A plastic structure intended to dissolve over one year or more.
• A titanium metal component that remains permanently in the body.

Despite their intended use for marking soft tissue, BioZorb Markers have not been FDA-approved for improving cosmetic outcomes, tissue filling, or use as markers in radiation therapy.

Serious Risks Linked to BioZorb Markers

The FDA has received reports of the following complications:

• Pain, infection, and rashes.
• Device migration (movement from its original position).
• Device erosion (protruding through the skin).
• Seroma formation (fluid buildup near the implant).
• Discomfort from feeling the device within the breast tissue.

In some cases, patients required additional medical intervention, including surgical removal of the device.

FDA’s Commitment to Public Safety

The FDA is actively working with Hologic to monitor BioZorb-related incidents and will provide further updates if new risks or developments emerge. To aid in tracking these devices, the FDA has implemented the Unique Device Identifier (UDI) system, which allows for accurate reporting and analysis of adverse events.

What You Should Do

• Patients: If you are experiencing issues, consult your healthcare provider and report complications to the FDA here.
• Healthcare Providers: Review patient cases, cease device use, and follow FDA guidelines for reporting adverse events.

For more information, visit the FDA’s Medical Device Safety page.

Stay informed and vigilant to ensure the safety and well-being of patients impacted by BioZorb Markers.