FDA Safety Communication: BioZorb Markers and Potential Risks Associated with Use in Breast Tissue

The potential risks of the device moving out of its implanted position (migration) and puncturing the chest cavity and/or blood vessels are severe and potentially life-threatening. Device migration could also affect the accuracy of future radiation targeting to the intended site.

The FDA is warning patients and healthcare providers about potential serious complications associated with the use of BioZorb Marker and BioZorb LP Marker devices manufactured by Hologic, Inc. These devices are implanted in soft tissues, including breast tissue, to mark sites for future medical procedures like radiation for breast cancer treatment.

Reports to the FDA have described complications with these devices, including infection, fluid buildup (seroma), device movement (migration), device breaking through the skin (erosion), pain, discomfort, rash, and other issues possibly linked to the device's resorbable component not being absorbed in the body for several years. Literature reports also mention similar adverse events such as device erosion through the nipple skin and device migration from the original implantation site.

While the FDA has cleared these devices for radiographic marking of soft tissue sites, including the breast, and for marking sites for future medical procedures, they have not been cleared or approved for filling tissue space or improving cosmetic outcomes after procedures.

Suggestions for Patients and Caregivers:

1. Have a thorough discussion with your healthcare provider about the advantages and disadvantages of all available breast tissue markers for breast cancer procedures.

2. If you encounter any issues with your implanted breast tissue marker, such as infection, pain, or a sense that the device has shifted, seek advice from your healthcare provider.

3. Notify the FDA of any problems or complications arising from BioZorb Marker and BioZorb LP Marker devices, or any other implantable breast tissue markers. Your report, combined with data from other sources, can contribute to enhancing patient safety.

Guidelines for Healthcare Providers:

1. Stay informed about reports of serious adverse events associated with the use of BioZorb Marker and BioZorb LP Marker devices in breast tissue.

2. Maintain regular monitoring of patients with implanted BioZorb Marker or BioZorb LP Marker for any signs of adverse events.

3. Note that the FDA has not approved the use of BioZorb Marker and BioZorb LP Marker to fill tissue space or improve cosmetic outcomes post-procedure.

4. Engage in thorough discussions with your patients regarding the advantages and risks of all available implantable breast tissue marking devices.

5. If you intend to implant a marking device during breast conservation surgery, inform your patient about the specific device you plan to use.

6. Report any issues or complications experienced by patients from procedures involving BioZorb Marker and BioZorb LP Marker, or any other implantable breast tissue markers, to the FDA.

Device Description:

The BioZorb Marker and BioZorb LP Marker are implantable markers used in radiography to mark soft tissue sites, including breast tissue, for future medical procedures like radiation. They consist of two components: a resorbable plastic part meant to be completely absorbed by the patient's body in one year or longer, and a permanent titanium metal component. Potential Risks Associated with the Use of BioZorb Marker and BioZorb LP Marker in Breast Tissue:

The FDA has received reports and is aware of published literature describing serious adverse events in patients implanted with BioZorb Marker or BioZorb LP Marker in breast tissue, including during procedures like lumpectomies.

The potential risks of the device moving out of its implanted position (migration) and puncturing the chest cavity and/or blood vessels are severe and potentially life-threatening. Device migration could also affect the accuracy of future radiation targeting to the intended site.

While medical device reports (MDRs) provide valuable information, this passive surveillance system has limitations. These include potential submissions of incomplete, inaccurate, untimely, unverified, or biased data. Furthermore, determining the incidence or prevalence of an event solely from this reporting system is challenging due to under-reporting, inaccuracies, lack of verification that the device caused the reported event, and insufficient information about the frequency of device use. Consequently, MDRs are just one of several important post-market surveillance data sources for the FDA.

The FDA is collaborating with Hologic Inc. to assess the safety of BioZorb Marker and BioZorb LP Marker devices in breast tissue and to mitigate potential risks associated with their use. Ongoing monitoring of adverse event reports will be conducted by the FDA, and the public will be updated if significant new information arises.

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