Surgery rate to fix vaginal mesh problems low, says study
Women have brought class-action lawsuits
Despite a growing number of lawsuits linked to the use of vaginal mesh implants, the proportion of women who need reparative surgery for complications from the device is relatively low — at least for those treated for stress incontinence, an Ontario study suggests.
A study by the Institute for Clinical Evaluative Sciences (ICES) found that about three per cent of women treated with a transvaginal mesh sling for stress incontinence — the kind of urine leakage typically brought on by laughing, coughing, sneezing or exercise — have needed surgery to remove or alter the implant.
“Our study shows that, after 10 years of followup, one in 30 Ontario women required mesh revision or removal surgery,” said principal researcher Dr. Blayne Welk, a urologist at St. Joseph’s Hospital in London, Ont., and an adjunct scientist at ICES.
Vaginal mesh implants are made from a polymer plastic and work by supporting the urethra, the tube through which urine flows, he said. “When there’s activity, the urethra can’t move and urine can’t leak out.”
The implants, the most common surgical intervention for female stress incontinence over the past 20 years, are also used to treat pelvic organ prolapse (POP), in which the bladder and uterus have begun to sag.
But in some cases, the slings can cause complications, such as chronic pelvic, genital or groin pain and an inability to properly urinate. Among the most serious adverse effects are infection, tissue erosion and organ perforation.
The 2002-2012 study published in the journal JAMA Surgery, on Sept. 9, examined health records for almost 60,000 Ontario women who received a vaginal mesh implant for stress incontinence. Researchers found that 1,307 were required to have the device removed or altered in some way as a result of complications.
Paul Miller, a partner in the Toronto law firm Will Davidson LLP, said he was surprised at the study’s one-in-30 finding, given that thousands of women in Canada (between 5,000 to 7,000), and the United States (50,000 to 70,000), have been or are plaintiffs in class-action and individual lawsuits against manufacturers of the mesh slings, which include Johnson and Johnson, and its subsidiary Ethicon, Boston Scientific and Atrium.
“One of the things I hear from women all the time — and it’s the saddest thing — is that ‘the doctor says it’s in my head. It’s not the mesh. There’s no problem with the mesh,’” said Miller.