FDA classifies recall of Hologic's implant as 'most serious'

Reuters
·1 min read
FILE PHOTO: A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring

(Reuters) -The U.S. Food and Drug Administration on Wednesday classified a recall of Hologic's devices that are implanted in soft tissue such as breast tissue as "most serious", and urged doctors to more actively monitor for side-effects.

The FDA said the recall of the device BioZorb Marker, initiated by Hologic in March, was not a product removal, but a correction.

The agency also urged patients to report any side effects they experience following the placement of the device, which is implanted before future medical procedures, such as radiation for breast cancer treatment.

Hologic was recalling the device after receiving reports of pain, infection or other complications from feeling the device in the breast.

There have been 71 reported injuries and no reports of death, the FDA said.

The health regulator in February warned patients and healthcare providers about the potential risk of serious complications arising from the use of BioZorb Marker.

(Reporting by Mariam Sunny and Sneha S K in Bengaluru; Editing by Shailesh Kuber)