Medtech in a Minute: Integra's Bold Decision, and More

Integra Makes a Bold Decision Following a Turbulent Year

Integra Lifesciences is closing its Lafayette, IN-based ACell plant, laying off all but one of the 60 non-union employees currently working at the site. The factory manufactures the Urinary Bladder Matrix portfolio of tissue products designed for hernia and abdominal wall repair. The company's Columbia, MA, factory will take over manufacturing of that product line.

Hologic BioZorb Devices Linked to Serious Complicatins

FDA is warning patients and healthcare providers of the potential risk of serious complications when using the Hologic BioZorb Marker and BioZorb LP Marker devices. The agency highlighted reports and published literature describing serious adverse events in patients who were implanted with the radiographic tissue markers 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. FDA said it has received reports of infection, fluid buildup, the device moving out of position, the device breaking through the skin, pain, discomfort, rash, and complications that may be related to an extended resorption time.