FDA Advises Against Use of BioZorb Markers in Breast Cancer and Other Indications

The FDA has advised that consumers, health care providers, and health care facilities not use the implantable radiographic biomarker devices BioZorb Markers and BioZorb LP Markers.¹

The alert follows an October 25, 2024, announcement from Hologic of a voluntary recall for removal of all lots of unused BioZorb Markers. The recall is due to reports of serious adverse effects (AEs) occurring in patients who had the devices implanted in breast tissue. Hologic first alerted health care providers regarding the possible health risks reported with the BioZorb Marker devices on February 27, 2024.²

Hologic received complaints from patients describing AEs including pain, infection, rash, device migration, device erosion, seroma, discomfort, and/or other complications from feeling the device in the breast, which, in some instances, required additional treatment, including having the device removed from the body. The company noted that out of the 91,531 devices sold since 2015, there were 399 complaints, of which 188 were associated with AEs as of October 16, 2024. The request for return of the unused BioZorb Markers was taken as a cautionary measure, according to Hologic.

BioZorb Markers are implantable devices used in soft tissues, including tissue of the breast. The devices are made up of 2 parts: a plastic component that is intended to dissolve in the patient’s body over the course of 1 year or more, as well as a permanent titanium component. The devices are indicated for radiographic marking of sites in soft tissue and are also indicated in instances where the sites need to be marked for future treatment. BioZorb Markers are not indicated to improve cosmetic outcomes following procedures, fill space in the tissue, or to be a marker for radiation therapy.¹

The FDA issued the following recommendations for patients and care givers regarding the BioZorb Marker devices:

• If patients experience any AEs with the device, they should contact their health care provider.
• Patients who have already had the device implanted do not need to have the device removed, unless advised by a health care provider.
• If radiation therapy is being planned, patients should discuss the possible risks with health care providers. The FDA has not cleared or approved the BioZorb Marker for use as a marker for radiation treatment.
• Patients should report any problems or complications with a device to the FDA.

For health care providers and facilities, the FDA recommended:

• Do not implant BioZorb Markers.
• Quarantine and return all lots of unused BioZorb Markers to Hologic.
• Review and discuss the previously listed recommendations for patients with those who have received a BioZorb Marker implant.
• Be aware of serious AEs following the placement of a BioZorb Marker in breast tissue.
• Continue to monitor patients with an implanted BioZorb Marker for signs of AEs.
• Be aware that the FDA has not cleared or approved the use of the devices to fill space in the tissue or to improve cosmetic outcomes following procedures or as a marker for radiation treatment.
• Report any problems or complications experienced by experience after the placement of BioZorb Marker devices to the FDA.

The FDA indicated that it will continue to collaborate with Hologic to monitor reports of issues with BioZorb Markers, including those that may develop over time. The organization will also continue to keep the public informed if significant new information becomes available. The FDA encouraged individuals to report any problems they experience with the devices via the MedWatch Voluntary Reporting Form.

References

1. Update: do not use BioZorb marker implantable radiographic marker devices: FDA safety communication. FDA. October 25, 2024. Accessed October 29, 2024. https://www.fda.gov/medical-devices/safety-communications/update-do-not-use-biozorb-marker-implantable-radiographic-marker-devices-fda-safety-communication
2. Urgent: medical device recall BioZorb® 3D bioabsorbable marker. News release. Hologic. October 24, 2024. Accessed October 30, 2024. https://www.hologic.com/biozorb-3d-bioabsorbable-marker-important-recall-information