The BioZorb implant, manufactured by Hologic, Inc., is a class II medical device first cleared by the FDA in 2012 under the 510(k) process. It is an implantable radiographic marker composed of a bioabsorbable material (polylactic acid) and six titanium radiopaque clips, which are designed to mark soft tissue sites during radiation therapy following breast cancer surgery. The device is intended to provide a three-dimensional marker for more precise radiation targeting while gradually dissolving in the body over time.
BioZorb works. But it has also been linked to several complications, including prolonged pain, discomfort, infection, device migration, and non-absorption. Many patients have reported the formation of hardened masses, scar tissue, and additional injuries at the implant site. The device has also been associated with increased radiation exposure and adverse reactions requiring further surgeries for removal.