Pharmaceutical

Recalled product inserted in patient

After suffering months of excruciating pain following surgery, a Virginia Beach, Va., woman learned yesterday that a recalled mesh patch had been used by the hospital where she underwent a hernia operation nearly a year ago. The Kugel Mesh patch, made by Davol Incorporated, was recalled by the FDA because it breaks up after insertion in patients, which can result in serious injury.

A report on WAVY TV-10 in Virgina Beach said the hospital initially denied using the recalled product on the patient, Judith Coyne. But Coyne and her son, who uncovered the mesh patch recall alert while researching possible reasons for his mother’s pain, found that the ID number on the hospital’s records for the mesh patch used during Judith’s surgery matched the product code and lot number for the recalled product.

The day after the initial television report, the hospital admitted it had made a mistake, and that doctors did, in fact, use the recalled product in Ms. Coyne’s procedure.

Judith Coyne is fearful about what happens next, as surgery to remove the damaged mesh patch could be life-threatening.