FDA warns of potential risk from Hologic's devices implanted in soft tissue

The headquarters of the U.S. Food and Drug Administration (FDA) is seen in Silver Spring, Maryland November 4, 2009. REUTERS/Jason Reed/File Photo

(Reuters) – The U.S. health regulator on Tuesday warned patients and healthcare providers about the potential risk of serious complications arising from the use of Hologic’s devices that are implanted in soft tissue.

The company’s devices, BioZorb Marker and BioZorb LP Marker, are implanted in soft tissue, including breast tissue, where the site needs to be marked for future procedures, such as radiation for breast cancer treatment.

The Food and Drug Administration said it has received reports on complications related to the use of the devices in breast tissue including infection, fluid buildup, device moving out of its position and breaking through the skin.

It has also received reports of pain, discomfort from feeling the device in the breast along with the need for additional medical treatment for the removal of the device.

Hologic did not immediately respond to a Reuters request for comment.

(Reporting by Sriparna Roy in Bengaluru; Editing by Shailesh Kuber)