FDA Issues Urgent Recall of BioZorb Markers Due to Reports of Serious Health Risks

As of October 25, 2024, the U.S. Food and Drug Administration (FDA) announced a significant safety recall concerning BioZorb Markers and BioZorb LP Markers, implantable medical devices produced by Hologic Inc. The FDA states that this recall is due to reported adverse events among patients who had these devices implanted in their breast tissue. Hologic’s voluntary recall involves removing all unused BioZorb Markers from circulation to address potential health risks effectively. The FDA’s immediate communication aims to informin consumers, healthcare providers, and healthcare facilities about the recall and provide guidance on necessary actions. The most recent recall notice can be found here:

https://www.fda.gov/medical-devices/medical-device-recalls/hologic-inc-recalls-biozorb-marker-due-complications-implanted-devices

What are BioZORB Markers?

The BioZorb Marker’s design is for radiographic marking. It is most commonly implanted in patients who have had a breast cancer tumor removed and need radiation therapy following removal.  The BioZorb marker is often used instead of traditional breast clips or markers because the manufacturer marketed the device to doctors as superior to more traditional implants.  It is also believed that the company improperly marketed to doctors that the device would also help fill tissue space or improve cosmetic outcomes, something that the FDA did not give the company permission to do. The FDA’s guidance underscores that BioZorb Markers should not be used beyond their specified indications, as these unapproved uses may pose unnecessary risks to patients.

Risks Associated with BioZORB Markers

The BioZorb Marker, initially approved to mark sites in soft tissue for future procedures, is now known to be associated with severe complications, especially when used in breast tissue. The FDA notes that patients have experienced various adverse reactions, including:

• Pain
• Infection
• Rash
• Device migration (moving out of its original position)
• Device erosion (breaking through the skin)
• Seroma (fluid buildup)
• Discomfort
• Other complications related to feeling the device in the breast

In many cases, these complications required additional medical intervention, including the surgical removal of the device (explantation). The FDA emphasizes that BioZorb Markers are not approved to enhance cosmetic outcomes or to serve as radiation treatment markers, as these uses fall outside the device’s cleared indications.

Recommendations for Patients and Caregivers

The FDA states that patients with an implanted BioZorb Marker should take specific precautions and seek medical guidance if they experience any issues. Here are the FDA’s recommendations for patients and their caregivers:

• Consult Your Healthcare Provider: If you encounter any adverse effects related to 

your BioZorb Marker, immediately contact your healthcare provider.

• Do Not Remove the Device Unless Advised: The FDA notes that patients do not need to have the device removed unless their healthcare provider specifically recommends it.
• Discuss Radiation Treatment Plans: If you are planning radiation therapy, discuss any potential risks of having the BioZorb Marker implanted, as the FDA has not approved it for use as a radiation treatment marker.
• Report Complications: The FDA encourages patients to report any problems associated with BioZorb Markers to their healthcare provider or directly to the FDA’s MedWatch Voluntary Reporting Form.

Guidance for Healthcare Providers and Facilities

For healthcare professionals, the FDA has outlined key recommendations:

• Do Not Use BioZorb Markers: Healthcare providers are advised to avoid implanting BioZorb Markers in any new patients.
• Return Unused Devices: All unused BioZorb Markers should be quarantined and returned to Hologic.
• Review Patient Information: Providers should communicate the FDA’s guidance and potential risks with patients who currently have a BioZorb Marker implanted.
• Monitor for Adverse Events: Providers are urged to closely observe patients with a BioZorb Marker for signs of adverse events and report any complications to the FDA.

These recommendations aim to safeguard patient health and prevent further complications.

KBA Attorneys: Advocating for Patients Affected by BioZORB Markers

KBA Attorneys is dedicated to defending individuals harmed by medical devices and is actively investigating cases involving BioZorb Marker complications. We have had a long-standing commitment to advocating for the rights of patients affected by adverse medical outcomes and will continue to support individuals who have experienced issues with BioZorb Markers. Our lawyers have decades of experience litigating and trying injury cases against pharmaceutical giants.  The firm is accepting cases from individuals impacted by this recent recall and is prepared to pursue justice on behalf of those who have suffered due to adverse events linked to BioZorb Markers.

Patients experiencing pain, infection, device migration, or other complications can turn to KBA Attorneys for legal support as they seek redress for their injuries. KBA Attorneys aims to hold medical device manufacturers accountable for harm caused by their products and ensure affected individuals receive fair compensation.

FDA’s Ongoing Actions and Device Identification

The FDA’s recent actions help assure that patients and doctors collaborate with manufacturer Hologic, Inc. to monitor reported issues involving BioZorb Markers. As more data emerges, the FDA pledges to keep the public informed about significant developments and any further guidance that may become necessary.

To help patients, caregivers, and healthcare providers identify specific BioZorb Marker models, the FDA offers device identifiers and model details. These identifiers aid in accurate reporting, reviewing, and analyzing adverse event reports, which can help isolate problematic devices more quickly.

Device Information Table:

The FDA emphasizes that patients and providers should use these identifiers to verify device details when reviewing cases or reporting issues.

Reporting Problems with BioZORB Markers

For individuals who suspect a problem with their BioZorb Marker, the FDA encourages reporting through the MedWatch Voluntary Reporting Form. This form allows patients, caregivers, and healthcare providers to report adverse events directly to the FDA, which will aid in tracking and responding to issues with these devices.

Conclusion and Disclaimer

The FDA’s recent recall notice on BioZorb Markers emphasizes the importance of safety and the responsibility of both manufacturers and healthcare providers in protecting patient health. Patients who have received BioZorb Markers should consult with their healthcare provider for advice on managing their condition and addressing any complications.

Disclaimer: KBA Attorneys is not providing medical advice through this post. Individuals should consult their healthcare provider to discuss their specific medical needs.