FDA In Safety Communication Says Do Not Use BioZorb Marker Implantable Radiographic Marker Devices; Hologic Recall Due To Reports Of Serious Adverse Events Occurring In Patients Who Had BioZorb Marker Devices Implanted In Breast Tissue

Benzinga · 10/25 17:13

https://www.fda.gov/medical-devices/safety-communications/update-do-not-use-biozorb-marker-implantable-radiographic-marker-devices-fda-safety-communication#:~:text=The%20FDA%20has%20received%20reports,from%20feeling%20the%20device%20in

 

Date Issued: October 25, 2024

The U.S. Food and Drug Administration (FDA) is alerting consumers, health care providers and health care facilities not to use BioZorb Markers and BioZorb LP Markers (hereafter referred to simply as BioZorb Markers) by Hologic Inc.

On October 25, 2024, Hologic announcedExternal Link Disclaimer a voluntary recall for removal of all lots of unused BioZorb Markers. The recall is due to reports of serious adverse events occurring in patients who had the devices implanted in breast tissue.

The FDA is issuing this communication to help ensure you are aware of the manufacturer's most recent recall notice and the recommended actions.

Recommendations for Patients with a BioZorb Marker and their Caregivers

  • If you experience any adverse events with your BioZorb Marker, please contact your health care provider.
  • There is no need to have the device removed from your body (explanted) unless advised by your health care provider.
  • If your provider is planning radiation therapy treatments, discuss the possible risks with your provider. The FDA has not cleared or approved the use of BioZorb Marker as a marker for radiation treatment.
  • Report any problems or complications with your BioZorb Marker to the FDA.

Recommendations for Health Care Providers and Facilities

  • Do not implant BioZorb Markers.
  • Quarantine and return all lots of unused BioZorb Markers to Hologic.
  • Review and discuss the Recommendations for Patients above with your patients who have a BioZorb Marker.
  • Be aware of reports of serious adverse events following the placement of BioZorb Marker devices in breast tissue.
  • Continue to monitor patients who have an implanted BioZorb Marker for signs of any adverse events.
  • Be aware the FDA has not cleared or approved the use of BioZorb Markers to fill space in the tissue or to improve cosmetic outcomes after procedures, or as a marker for radiation treatment.
  • Report any problems or complications your patients experience following the placement of BioZorb Marker devices to the FDA.

Device Description

BioZorb Markers are implantable devices used in soft tissue sites, including breast tissue. BioZorb Markers have two parts: a plastic component that is intended to be dissolved completely in the patient's body in one year or longer, and a titanium metal component that is permanent.

The BioZorb Marker is indicated for radiographic marking of sites in soft tissue. In addition, the BioZorb Marker is indicated in situations where the soft tissue site needs to be marked for future medical procedures.

The BioZorb Marker is not indicated to improve cosmetic outcomes after procedures, fill space in the tissue, or to be a marker for radiation treatment.

Risks Associated with BioZorb Marker in Breast Tissue

Reported complications and adverse events with BioZorb Marker that include serious injuries are:

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

In some instances, additional medical treatment, including having the device removed from the body (explantation), was needed.

FDA Actions

The FDA will continue to work with Hologic to monitor reports of problems with BioZorb Markers, including issues that may develop over time.

The FDA will continue to keep the public informed if significant new information becomes available.