Date Issued: February 27, 2024

The U.S. Food and Drug Administration (FDA) is informing patients and health care providers about the potential risk of serious complications with the use of BioZorb Marker and BioZorb LP Marker devices by Hologic, Inc. The BioZorb Marker and BioZorb LP Marker are devices implanted in soft tissue, including breast tissue, where the site needs to be marked for future medical procedures, such as radiation for breast cancer treatment.

The FDA has received reports describing complications (adverse events) with the use of BioZorb Marker and BioZorb LP Marker in breast tissue, including infection, fluid buildup (seroma), device moving out of position (migration), device breaking through the skin (erosion), pain, discomfort from feeling the device in the breast, rash, other complications possibly associated with extended resorption time (resorbable component of the device not resorbing in the patient's body for several years), and the need for additional medical treatment to remove the device. The FDA is also aware of literature reports describing similar adverse events including the device breaking through the skin of the nipple (erosion) and the device moving out of position from where it was implanted (migration).

The FDA has cleared BioZorb Marker and BioZorb LP Marker for radiographic marking of sites in soft tissue (including breast). In addition, the markers are indicated in situations where the soft tissue site (including breast) needs to be marked for future medical procedures. The FDA has not cleared or approved these devices to fill space in the tissue or to improve cosmetic outcomes after procedures.

Recommendations for Patients and Caregivers

• Discuss the benefits and risks of all available implantable breast tissue markers for breast cancer procedures with your health care provider.
• If you have any problems with your implanted breast tissue marker, including infection, pain, or feeling that the device has moved, consult with your health care provider.
• Report any problems or complications experienced from BioZorb Marker and BioZorb LP Marker devices, or any other implantable breast tissue markers, to the FDA. Your report, along with information from other sources, can provide information that helps improve patient safety.

Recommendations for Health Care Providers

• Be aware of reports of serious adverse events with use of BioZorb Marker and BioZorb LP Marker devices in breast tissue.
• Continue to monitor patients who have an implanted BioZorb Marker or BioZorb LP Marker for signs of any adverse events.
• Be aware the FDA has not cleared or approved the use of BioZorb Marker and BioZorb LP Marker 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 patient.
• If you plan to implant a marking device during breast conservation surgery, inform your patient which device you plan to use.
• Report any problems or complications experienced by patients from procedures with BioZorb Marker and BioZorb LP Marker, or any other implantable breast tissue markers, to the FDA.

Device Description

BioZorb Marker and BioZorb LP Marker are implantable radiographic markers used to mark soft tissue sites, including breast tissue, for future medical procedures, such as radiation. The BioZorb Marker and BioZorb LP Marker have two components: a resorbable plastic component that is intended to be resorbed completely by the patient's body in one year or longer, and a titanium metal component that is permanent.

Potential Risks Associated with the Use of BioZorb Marker and BioZorb LP Marker devices in Breast Tissue

The FDA has received reports and is aware of published literature describing serious adverse events in patients who were implanted with the BioZorb Marker or BioZorb LP Marker devices in the breast tissue, including during breast conservation procedures such as a lumpectomy.

The potential consequences of the device moving out of position from where it was implanted (migration) and breaking through the chest cavity and/or blood vessels are severe and potentially life-threatening should it occur. Migration of the device may also impact future targeting of radiation to the intended site.

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 this reporting system alone due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about frequency of device use. Because of this, MDRs comprise only one of the FDA's several important postmarket surveillance data sources.

FDA Actions

The FDA is working with Hologic Inc. to evaluate all available information about the safety of BioZorb Marker and BioZorb LP Marker devices and to address potential risks when used in breast tissue.

The FDA will continue to monitor reports of adverse events. The FDA will keep the public informed if significant new information becomes available.

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that problem devices can be identified and corrected more quickly.

• How do I recognize a UDI on a label?
• AccessGUDID database - Identify Your Medical Device
• Benefits of a UDI System

You can find the UDI provided by Hologic, Inc. for BioZorb Marker and BioZorb LP Marker devices by checking the table below.

Version or Model	Device Brand Name	Device Description	Device Identifier (DI) Number
F0405	BioZorb Bioadsorbable Marker	BioZorb Marker 4cm x 5cm	15420045514065
F0404	BioZorb Bioadsorbable Marker	BioZorb Marker 4cm x 4cm	15420045514058
F0304	BioZorb Bioadsorbable Marker	BioZorb Marker 3cm x 4cm	15420045514010
F0303	BioZorb Bioadsorbable Marker	BioZorb Marker 3cm x 3cm	15420045514003
F0203	BioZorb Bioadsorbable Marker	BioZorb Marker 2cm x 3cm	15420045513990
F0202	BioZorb Bioadsorbable Marker	BioZorb Marker 2cm x 2cm	15420045513983
F0331	BioZorb LP Bioadsorbable Marker	BioZorb Marker 1cm x 3cm x 3cm	15420045514041
F0231	BioZorb LP Bioadsorbable Marker	BioZorb Marker 1cm x 3cm x 2cm	15420045514034
F0221	BioZorb LP Bioadsorbable Marker	BioZorb Marker 1cm x 3cm x 2cm	15420045514027

Reporting Problems with Your Device

If you think you had a problem with your device, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.

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

Questions?

If you have questions, email the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV or call 800-638-2041 or 301-796-7100.

Additional Resources

• From Hologic Inc.: Medical Device Safety Notification BioZorb Marker