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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 announced 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.
A timeline and summary of the FDA's previous communications related to these devices is provided below.
| Date | Event |
|---|---|
| 02/27/2024 | The FDA issued a safety communication about the potential risk of serious complications with the use of BioZorb Marker and BioZorb LP Marker devices by Hologic, Inc. |
Unique Device Identifier
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 devices can be identified, and problems potentially corrected more quickly.
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, contact CDRH's Division of Industry and Consumer Education (DICE).
