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FDA classifies recall of Hologic's implant as 'most serious'
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FDA classifies recall of Hologic's implant as 'most serious'
May 22, 2024 11:54 AM

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.

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