FDA Warns Hologic BioZorb Marker Implants Pose Serious Risk

March 1, 2024

Soft tissue markers BioZorb and BioZorb LP pose a potential risk of serious complications said the FDA in a safety communication released Tuesday.

Made by Hologic, the markers are implanted in soft tissue where the site needs to be marked for future medical procedures, such as radiation for breast cancer treatment according to the FDA.

The FDA said it has received reports describing complications with the use of the markers in breast tissue, including infection, pain, fluid buildup, the devices moving out of position and/or breaking through the skin as well as the need for additional medical treatment to remove the devices.

Read the FDA safety communication here.

To read the whole story, click here to subscribe.

Related Topics