Roughly one in 30 women who have a vaginal mesh sling inserted to treat incontinence will need surgery again in less than 10 years to remove or replace the implant, according to a study published in JAMA Surgery‘s September issue. With about 100,000 federal lawsuits filed by women who say mesh implants caused them severe injuries, this report is timely. The group of mesh lawsuits is now one of the biggest actions in U.S. history.
The study – led by Dr. Blayne Welk of Department of Surgery, Western University, St Joseph’s Health Care, London, Ontario, Canada – examined the cases of 59, 887 women implanted with mesh for stress urinary incontinence (SUI). The average age of the women studied was 52. The study’s authors found that one in 30 women incurred a risk of undergoing a second surgery within 10 years to either remove or revise the implant.
The authors of the study wrote: “Synthetic mesh slings are the most common surgical treatment for female stress urinary incontinence (SUI). However, the U.S. Food and Drug Administration has released warnings that question the safety of vaginal mesh.”
Study Supports FDA Recommendations
Welk and colleagues say the purpose of the study was to find out how many women needed a second surgery, or revision, after receiving a vaginal mesh implant. The study’s authors also wanted to see if the experience of the surgeon had any bearing on results.
Women in the sample group suffered complications, including erosion, fistulas, pain and retention. The authors stated that patients fared better when their surgeon was more experienced or did a higher volume of these types of surgeries. “These findings support the recommendations of the U.S. Food and Drug Administration related to the use of vaginal mesh for the treatment of SUI,” the authors wrote.
FDA: Mesh Complications ‘Are not Rare’
While some experts say a one in 30 risk of additional surgery and complications is low, the FDA’s own 2011 report says that complications from mesh implants “are not rare.”
Further, the agency acknowledged that these types of surgeries do not necessarily improve a woman’s quality of life. When other procedures for incontinence or prolapse are available, the FDA recommends that doctors use them.
In 2014, the FDA released a new statement about the risks of mesh use to treat pelvic organ prolapse (POP) – a condition causing a woman’s organs to sag into the vagina. The mesh acts like a net to hold up sagging organs.
“The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those risks for more safe and effective products,” said William Maisel, M.D., M.P.H., deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health. “If these proposals are finalized, we will require manufacturers to provide premarket clinical data to demonstrate a reasonable assurance of safety and effectiveness for surgical mesh used to treat transvaginal POP repair.”
Despite the controversy, the FDA actually approved Caldera Medical’s new Vertessa Lite mesh device in April 2015. The agency has yet to take additional action on reclassifying mesh to a high-risk device as it has proposed.