May 22 (Reuters) - The U.S. Food and Drug Administration
on Wednesday classified a recall of Hologic's ( HOLX ) 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 ( HOLX ) 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 ( HOLX ) 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.