The agency received reports from nine surgical mesh manufacturers who said patients had experienced erosion through the vagina, infection, pain, urinary problems and recurrence of prolapse or incontinence. There also were reports of bowel, bladder and blood vessel perforation during insertion, the FDA said.
"[The] FDA has received reports of complications associated with the placement of mesh through an incision made in the wall of the vagina," the notice stated. "Although rare, these complications can have serious consequences. The reports have not been linked to a single brand or model of mesh."
In some cases, the notice added, erosion of the mesh and scarring of the vagina led to discomfort and pain. Some patients needed additional surgery to remove the mesh that had eroded into the vagina.
SOURCE: FDANEWS