As of May 22, the company has received 71 injury reports related to nine BioZorb Marker models. There are more than 53,000 devices in the U.S. market, according to the FDA.
The spiral-shaped, bioabsorbable device is designed to mark surgical excision sites. In March, Hologic sent letters to patients and healthcare workers detailing potential adverse events.
“Complaints included reports of pain, infection, rash, device migration, device erosion, seroma, discomfort, or other complications from feeling the device in the breast, and the need for additional medical treatment to remove the device,” the FDA said, adding that this notice is a product correction notice, not a product removal.
At the Becker's 11th Annual IT + Revenue Cycle Conference: The Future of AI & Digital Health, taking place September 14–17 in Chicago, healthcare executives and digital leaders from across the country will come together to explore how AI, interoperability, cybersecurity, and revenue cycle innovation are transforming care delivery, strengthening financial performance, and driving the next era of digital health. Apply for complimentary registration now.
