FDA Issues Safety Communication for Use of BioZorb Markers in Breast Tissue

February 28, 2024

On February 27, 2024, the U.S. Food and Drug Administration (FDA) issued a safety communication (https://www.fda.gov/medical-devices/safety-communications/biozorb-markers-and-potential-risks-use-breast-tissue-fda-safety-communication) to patients and healthcare providers about the potential risk for serious complications with BioZorb Marker and BioZorb LP Marker devices by Hologic, Inc., which are implanted in soft tissue, including breast tissue, to mark a site for medical procedures (e.g., radiation therapy for breast cancer treatment).

FDA update

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:

Version or Model

Device Brand Name

Device Description

Device Identifier (DI) Number

F0405

BioZorb Bioadsorbable Marker

BioZorb Marker 4 cm x 5 cm

15420045514065

F0404

BioZorb Bioadsorbable Marker

BioZorb Marker 4 cm x 4 cm

15420045514058

F0304

BioZorb Bioadsorbable Marker

BioZorb Marker 3 cm x 4 cm

15420045514010

F0303

BioZorb Bioadsorbable Marker

BioZorb Marker 3 cm x 3 cm

15420045514003

F0203

BioZorb Bioadsorbable Marker

BioZorb Marker 2 cm x 3 cm

15420045513990

F0202

BioZorb Bioadsorbable Marker

BioZorb Marker 2 cm x 2 cm

15420045513983

F0331

BioZorb LP Bioadsorbable Marker

BioZorb Marker 1 cm x 3 cm x 3 cm

15420045514041

F0231

BioZorb LP Bioadsorbable Marker

BioZorb Marker 1 cm x 3 cm x 2 cm

15420045514034

F0221

BioZorb LP Bioadsorbable Marker

BioZorb Marker 1 cm x 3 cm x 2 cm

15420045514027

Recommendations for Patients and Caregivers

Recommendations for Healthcare Professionals

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.


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