Removal of Faulty Mesh for Incontinence
Experts say there's still no clear-cut answer as to whether or not to have surgery
The study, however, had its own limits. The researchers sent surveys to nearly 700 women who'd had surgery at their center, but only one-third responded. It's possible that women who'd continued to have problems were more likely to respond.
So what should women do? Zimmern said that despite the good results in his study, women should not rush into surgery.
"We can only say that in this subset of patients, the outcomes were better than we expected," Zimmern said.
It can't be assumed that the results would extend to women more generally. For one, Zimmern explained, pain was the only reason for device removal, and it's not clear that the outcomes would be the same for women who had pain and other symptoms.
Plus, Zimmern said, the study included no patients who'd gone with nonsurgical options -- like physical therapy for the pelvic floor muscles, or "trigger point" injections with medications that ease pain and inflammation.
"This study might have included a select group of women," Zimmern said.
The issue is complicated, agreed Dr. Tomas Griebling, a professor of urology at the University of Kansas Medical Center in Kansas City.
"I think most [doctors] would advise patients with no adverse signs or symptoms that they do not need to undergo surgical removal of mesh implants," said Griebling, who was scheduled to moderate a discussion of the studies at the meeting.
But when it comes to women who are having symptoms, the decision about what to do is not clear-cut.
Zimmern suggested that the safest course is to try nonsurgical options first. When women do opt for surgery, they need to realize that some symptoms might improve while others might get worse, Griebling said.
If you had incontinence before the mesh was implanted, then developed pain because of mesh erosion, removing it might ease your pain. "But you might experience worse incontinence," Griebling said.
He and Zimmern both suggested that women read the FDA recommendations on the devices, available on the agency's website.
The implants are still in use, and the recent FDA action applies only to vaginal mesh used for pelvic organ prolapse -- and not the other uses for mesh implants. They are often used to treat stress incontinence and as part of abdominal surgery for pelvic organ prolapse, for example.
Because these studies were presented at a meeting, findings should be viewed as preliminary until they've been published in a peer-reviewed journal.