According to a national vaginal mesh trial led by the University of Aberdeen in Scotland, the device is not better than standard repair surgery and even poses unnecessary risks.
Mesh, used as a treatment for pelvic organ prolapse (POP), can cause severe damage. The largest randomized vaginal mesh trial shows vaginal mesh implants “have been found to be no more effective than the existing standard repair technique, up to two years after surgery”.
Why is vaginal mesh controversial?
Doctors introduced vaginal mesh as a treatment for POP in the 1970s. It was initially regarded as a more effective option than traditional reparative surgery. Though non-absorbable mesh was believed to be better, there was no clear research illustrating the side effects of mesh, nor how the device impacts the overall quality of life.
“There was not enough information about adverse effects to enable women and their doctors to judge which operation was safest,” according to the University of Aberdeen News.
More than one in ten women who had synthetic mesh experienced a complication.
Complications arising from vaginal mesh use include:
- Erosion (also called exposure, extrusion or protrusion)
- Abdominal pain
- Urinary problems
- Organ perforation
- Recurrent prolapse
- Neuro-muscular problems
- Vaginal scarring/shrinkage
- Emotional problems
- Sexual problems
Vaginal Mesh Trial
The PROSPECT study, or PROlapseSurgery: Pragmatic Evaluation and Randomized Controlled Trials, was conducted by researchers at the University of Aberdeen. The study focused on developing a better understanding of the risks and effectiveness of non-absorbable synthetic mesh or biological grafts.
The study was funded by a National Health Service (NHS) research grant. Published in peer-reviewed journal, The Lancet, the research also included contributions from Glasgow Caledonian University, NHS Grampian, Plymouth Hospitals NHS Trust, Central Manchester University Hospitals, and NHS Foundation Trust.
The national project compared the synthetic mesh or biological grafts to traditional surgery, also referred to as native tissue repairs. The study included 1,348 women and is considered to be the largest randomized trial of the use of mesh or graft in transvaginal prolapse surgery.
Researchers conducted two parallel randomized trials in 35 different U.K. hospitals. Mesh used to treat POP was implanted by more than 100 doctors between January 2010 and August 2013. Women then responded to a questionnaire, called the Pelvic Organ Prolapse Symptom Score or POP-SS, to assess symptoms and side effects.
The mesh created complications and did not offer benefits that differed from traditional methods. Researchers deemed vaginal mesh repairs an “unnecessary risk” without clear benefits, which may result in the need for additional surgeries.
Researchers recommend synthetic mesh should only be used in clinical trials to identify better materials or to improve insertion methods.
“Because mesh did result in a number of complications, with no clear benefits, we conclude its use for these procedures could be considered an unnecessary risk,” Professor Cathryn Glazener told the University of Aberdeen News. “Therefore we consider that mesh should only be used in the future in high-quality clinical trials aimed at improving the results of vaginal prolapse surgery.”
POP affects an estimated 40 percent of women, often during the aging process. About one in 20 women will require reparative surgery and three in 10 will require additional surgery 12 years later.
In June 2014, Scotland banned vaginal mesh for its lack of a clear safety profile. However, the Food and Drug Administration still allows vaginal mesh to be implanted in women across the United States.
PROSPECT (PROlapse Surgery: Pragmatic Evaluation and randomised Controlled Trials). University of Aberdeen. December 20, 2016.