Surgical mesh designed to help women has been the focus of an FDA investigation, lawsuits, and even a move to have them recalled.
More than 15 hundred reports of complications have been made relating to the mesh, which is implanted during pelvic repair procedures.
Four years after pelvic surgery, Sonnia Andino came to see Dr. Vivian Aguilar at Cleveland Clinic Florida, reporting uncomfortable symptoms “like something pulling me. [I was] in pain and I couldn't stretch my leg or bend like that because I feel the pressure.”
Mesh had been implanted transvaginally to help fix pelvic organ prolapse, or POP, which occurs when the bladder or uterus drop into the vaginal area.
“What we've seen with these meshes in certain patients [is] the meshes aren't healing well. They are either eroding through the vagina or causing vaginal strictures or bands that are painful to the patient,” explained Dr. Aguilar.
In July, the FDA issued an alert about the use of surgical mesh for transvaginal POP surgery, stating serious complications are not rare, using mesh may expose patients to greater risk, and there's no evidence of any added benefit.
When problems develop, surgeons have to try to remove the mesh.
“It's technically difficult to remove the mesh, because the tissue grows into it so well and scars into place that sometimes it's very difficult," said Aguilar. "You have to take someone back multiple times to remove the mesh."
Andino has already had one removal surgery, but still has issues with bladder control and pain. She faces another operation after the new year.
Dr. Aguilar says mesh should be avoided in women who are sexually active, but might be helpful after menopause when tissues are more fragile and need extra support.
Published at 10:33 PM EDT on Oct 19, 2011 | Updated at 10:40 PM EDT on Oct 19, 2011