On October 25, 2024, the U.S. Food and Drug Administration (FDA) issued a critical advisory, cautioning consumers, healthcare professionals, and medical facilities against the use of BioZorb Markers and BioZorb LP Markers, two implantable radiographic devices designed for breast tissue applications. 

This warning follows a voluntary recall by the manufacturer, Hologic, after the devices were associated with serious adverse effects (AEs) in patients.

The recall stems from growing concerns over patient safety. Although initially introduced as a helpful tool for radiographic imaging and treatment planning, BioZorb Markers became the subject of complaints from patients and healthcare providers. 

These complaints highlighted complications that included:

• Persistent pain
• Infections
• Skin rashes
• Erosion of the device into surrounding areas
• Seromas (fluid buildup at the implant site)
• Migration or movement of the device within breast tissue
• General discomfort or heightened awareness of the device

Between 2015 and October 2024, 91,531 BioZorb devices were distributed globally. Of these, 399 complaints were officially recorded, with 188 directly linked to adverse effects. Although this accounts for less than 0.5% of the devices sold, the recall was issued as a precautionary step to mitigate further risks. Importantly, the recall applies only to unused devices, while implanted markers will remain under clinical surveillance.

What Are BioZorb Markers?

BioZorb Markers are implantable devices designed to help healthcare providers mark soft tissue areas, such as those in the breast, for imaging purposes or for guiding future treatment decisions. Each device has two distinct components:

1. Dissolvable Plastic Framework: This component gradually breaks down within the body over the course of a year or more.
2. Permanent Titanium Clips: These clips stay embedded in the tissue indefinitely, serving as a long-term radiographic marker.

Despite their usefulness, BioZorb Markers are not authorized for marking locations for radiation therapy or for cosmetic uses like enhancing breast contour or filling tissue gaps.

To help patients deal with their worries with BioZorb Markers, the FDA has provided the following particular recommendations:

1. Be Aware of Symptoms: Patients should seek examination from their healthcare practitioner right away if they develop discomfort, irritation, or other issues.
2. No Automatic Removal Needed: Unless it is absolutely required by a doctor, most patients with implanted devices are not encouraged to have them removed. A provider’s clinical judgment and the patient’s symptoms should guide this choice.
3. Talk About Possible Radiation Therapy Risks: It’s crucial for anyone thinking about radiation therapy to speak with a doctor in order to assess the dangers of utilizing the marker.
4. Report Adverse Reactions: Patients having issues are encouraged to file complaints via the FDA’s MedWatch Voluntary Reporting Form.

Recommendation for healthcare providers 

Healthcare institutions and providers are essential in reducing potential risks related to BioZorb Markers. The following measures have been suggested by the FDA:

• Stop implantation of BioZorb Markers immediately.
• Return Unused Devices: Put unused inventory in quarantine and work with Hologic to arrange returns.
• Observe Current Patients: Pay close attention to patients who have previously had the markers implanted and take quick action to resolve any issues.
• Educate and Communicate: Let patients know about the device’s recall and possible hazards.
• Report Incidents: The FDA should be notified right away of any negative effects or device problems.

Additionally, providers are cautioned that the FDA has not approved BioZorb Markers for use as instruments for radiation therapy marking or for cosmetic modifications.

This recall emphasizes how important it is to actively monitor medical devices, particularly those with comparatively low rates of problems. To guarantee thorough risk evaluation, the FDA and Hologic continue to keep an eye on reports of side effects connected to BioZorb Markers. Updates to the public will be given if new information on long-term safety issues or other hazards becomes available.

This recall serves as a reminder to healthcare systems of the need of following FDA-approved indications for medical devices and keeping up-to-date post-market monitoring systems.

Patient and Provider Collaboration

The FDA actively promotes open communication between patients and their healthcare providers in order to minimize risks and ensure patient safety. It is recommended that people with BioZorb Markers stay aware of the possible risks associated with the device and work with their providers to decide on the best course of action.

The FDA’s MedWatch Program, which continues to be an essential instrument for obtaining information to guide regulatory decisions and improve public safety, allows users to report difficulties or negative effects.

The BioZorb Markers recall emphasizes how crucial it is to continue to strictly monitor medical devices and put patient safety first. Better health outcomes for everyone can be ensured by promoting cooperation between regulators, manufacturers, and healthcare practitioners in order to better identify and minimize the risks associated with medical breakthroughs.

In the quickly changing world of medical device technology, this example serves as a reminder of the ongoing need for attentiveness, openness, and flexibility.