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.
