FDA Warns Against BioZorb Markers Due to Adverse Events
Key Insights
The FDA advises against using BioZorb and BioZorb LP Markers (search) due to reported adverse events following Hologic's voluntary recall.
Hologic recalled all lots of unused BioZorb Markers (search) after receiving complaints of pain, infection, and device migration in breast tissue.
The FDA recommends healthcare providers quarantine and return unused markers and monitor patients with implanted devices for adverse events.
The FDA has issued a safety communication advising against the use of BioZorb Markers (search) and BioZorb LP Markers (search), implantable radiographic biomarkers used in soft tissues, including breast tissue. This alert follows Hologic's voluntary recall on October 25, 2024, of all lots of unused BioZorb Markers due to reports of serious adverse events (AEs) in patients with implanted devices.
Hologic's initial alert to healthcare providers on February 27, 2024, highlighted potential health risks associated with BioZorb Markers (search). As of October 16, 2024, the company had received 399 complaints out of 91,531 devices sold since 2015, with 188 linked to AEs. These complaints included pain, infection, rash, device migration, device erosion, seroma, discomfort, and other complications related to the device's presence in the breast, sometimes requiring device removal.
BioZorb Markers (search) consist of a plastic component designed to dissolve over a year or more and a permanent titanium component. They are indicated for radiographic marking of sites in soft tissue for future treatment. The FDA emphasizes that these markers are not intended to improve cosmetic outcomes, fill space, or serve as markers for radiation therapy.
FDA Recommendations
The FDA has issued specific recommendations for patients and healthcare providers.
For Patients and Caregivers:
- Contact your healthcare provider if you experience any adverse effects with the device.
- Device removal is not necessary unless advised by a healthcare provider.
- Discuss potential risks with healthcare providers if radiation therapy is planned, as the FDA has not cleared or approved BioZorb Markers for this use.
- Report any problems or complications with the device to the FDA.
For Healthcare Providers and Facilities:
- Do not implant BioZorb Markers.
- Quarantine and return all unused BioZorb Markers to Hologic.
- Review and discuss patient recommendations with those who have received a BioZorb Marker implant.
- Be aware of serious AEs following BioZorb Marker placement in breast tissue.
- Continue monitoring patients with implanted BioZorb Markers for signs of AEs.
- Be aware that the FDA has not cleared or approved the devices to fill space in the tissue, improve cosmetic outcomes, or as a marker for radiation treatment.
- Report any problems or complications experienced after BioZorb Marker placement to the FDA.
The FDA will continue collaborating with Hologic to monitor reports of issues with BioZorb Markers (search) and will keep the public informed of any significant new information. Individuals are encouraged to report any problems experienced with the devices via the MedWatch Voluntary Reporting Form.