Adverse Events Reported for Hologic BioZorb Marker, BioZorb LP Marker

FDA is advising patients and healthcare providers to be aware of potential risk of serious complications when using the Hologic BioZorb Marker and BioZorb LP Marker devices. In a recent safety communication, the agency highlighted reports and published literature describing serious adverse events (AEs) in patients who were implanted with the device in breast tissue.

Both the BioZorb Marker and BioZorb LP Marker are implantable radiographic markers used to mark soft tissue sites, including breast tissue, for future medical procedures like radiation for breast cancer treatment. The devices are comprised of two components — a resorbable plastic component that is intended to be resorbed completely by the patient’s body in a year or longer and a permanent titanium metal component.

The devices are FDA cleared for radiographic marking of sites in soft tissue and are indicated in situations where the soft tissue site needs to be marked for future medical procedures. FDA has not, however, cleared or approved the devices to fill space in the tissue or to improve cosmetic outcomes after procedures.

FDA wrote it has received reports of serious AEs in patients implanted with the devices in the breast tissue, including during breast conservation procedures like lumpectomy. Described complications include infection, fluid buildup, the device moving out of position, the device breaking through the skin, pain, discomfort from feeling the device in the breast, rash, complications possibly related with an extended resorption time — not resorbing in the patient’s body for several years, and the need for additional medical treatment to remove the device. Additionally, literature reports have shown similar AEs including the device breaking through the skin of the nipple and moving out of position from when it was initially implanted.

Consequences for the device migrating from where it was implanted and breaking through the chest cavity or blood vessels can be potentially life-threatening and impact future targeting of radiation to the intended site.

FDA is recommending that healthcare providers continue to monitor patients with the implant for signs of AE’s, discuss the benefits and risks of all available breast tissue marking devices with patients, and if planning to use a marking device during breast conservation surgery, inform the patient of which device is being used. The agency also wrote to be aware that BioZorb Marker and BioZorb LP Marker are not cleared or approved to fill space in the tissue or to improve cosmetic outcomes after procedures.

Working with Hologic, FDA wrote that it will continue to monitor AE reports and encourages the public to report any problems with the device through the MedWatch Voluntary Reporting Form.