FDA said (https://www.fda.gov/medical-devices/safety-communications/biozorb-markers-and-potential-risks-use-breast-tissue-fda-safety-communication) it received reports of adverse events with the use of BioZorb Marker and BioZorb LP Marker in breast tissue, including infection, seroma, migration, erosion, pain, discomfort, rash, other complications possibly associated with extended resorption, and the need for additional medical procedures to remove the device. FDA said that literature reports have described similar adverse events.

The potential consequences of the device moving out of its implanted position (migration) and breaking through the chest cavity or blood vessels are severe and potentially life-threatening, FDA said (https://www.fda.gov/medical-devices/safety-communications/biozorb-markers-and-potential-risks-use-breast-tissue-fda-safety-communication). Migration could  also have implications for targeting future radiation to the intended site.

In the communication, FDA said (https://www.fda.gov/medical-devices/safety-communications/biozorb-markers-and-potential-risks-use-breast-tissue-fda-safety-communication) that it cleared BioZorb Marker and BioZorb LP Marker for radiographic or future procedure marking of soft tissue sites, including the breast, but it has not cleared or approved the devices to fill space in the tissue or to improve cosmetic outcomes after procedures.

The following device products are affected:

Recommendations for Patients and Caregivers

• Discuss the benefits and risks of all available implantable breast tissue markers with your healthcare team.
• If you have any problems with your implanted breast tissue marker, including infection, pain, or feeling that the device has moved, consult with your healthcare team.
• Report any problems or complications (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home) you experience from BioZorb Marker and BioZorb LP Marker devices, or any other implantable breast tissue markers, to FDA. Your report, along with information from other sources, can provide information that helps improve patient safety.

Recommendations for Healthcare Professionals

• Be aware of reports of serious adverse events with use of the BioZorb devices in breast tissue.
• Monitor patients who have an implanted BioZorb Marker or BioZorb LP Marker for signs of any adverse events.
• Be aware that FDA has not cleared or approved the BioZorb markers to fill space in the tissue or to improve cosmetic outcomes after procedures.
• Discuss the benefits and risks of all available implantable breast tissue marking devices with your patients.
• If you plan to implant a marking device during breast conservation surgery, inform your patient which device you use.
• Report any problems or complications (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home) that patients experience from procedures with BioZorb Marker and BioZorb LP Marker or any other implantable breast tissue markers.

FDA also cautioned healthcare professionals that although medical device reports (MDRs) are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from the MDRs system alone because many events are underreported, inaccurate, lack verification that the device caused the event, and lack of information about frequency of device use. FDA noted that MDRs comprise only one of its several postmarket surveillance data sources.

Reporting Problems With BioZorb Markers 

Patients who have a problem with their device should report it through FDA’s MedWatch Voluntary Reporting Form (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home).

Healthcare professionals employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

Patients and healthcare professionals can email any questions to FDA’s Division of Industry and Consumer Education at DICE@f (mailto:DICE@FDA.HHS.GOV)da.hhs.gov (mailto:DICE@FDA.HHS.GOV) or call 800-638-2041 or 301-796-7100.