Study Halted Due to Mesh Complications
This study, Vaginal Mesh for Prolapse: A Randomized Controlled Trial, was published in the August 2010 issue of the journal, Obstetrics & Gynecology. A three month double-blind trial recruited 65 women from three academic sites – Washington Hospital Center, (Washington, D.C.) Stanford University and Yale University. All of the women suffered from pelvic organ prolapse and entered the studies from January 2007 to August 2009.
Some of the women received Prolift synthetic mesh kits donated to the project by Ethicon, a division of Johnson & Johnson. The study authors did not report any potential conflicts of interest with Ethicon . The study was supported by a grant from the AUGS Foundation (American Urogynecologic Society which supports mesh use among other treatments) and the MedStar Health Research Institute Intramural Grant Program.
The women had prolapse in stage 2 -meaning the vaginal wall falls slightly through the vagina up to stage 4 – where the entire vagina protrudes through the opening. Women received sutures of the relaxed vagina with and without mesh. The success was to be measured at three months when the pelvic organ prolapse was expected to be measured at stage 1 or lower.
Here’s what happened
The study was stopped in August 2009 when 15.6% of the women experienced erosion at a median follow-up time period of 9.7 months. Mesh erosion occurred at two weeks, six weeks, seven weeks and 2.1 months and were located along the incision lines. The erosions were seen with propylene mesh and not with sling mesh. Three out of five required additional surgeries to remove the mesh.
The study concluded there was a high vaginal erosion rate of 15.6% with no difference in the cure rates. Because this number had surpassed the criteria of the study of 15%, the trial was halted.
Erosion is a wound breakdown from an infected mesh. It can cause pain, scarring, painful intercourse, bleeding scarring and closing of the vagina eroding into the bladder and bowel. Mesh erosion through the vagina is also called exposure, protrusion or extrusion. Many of these problems required additional medical or surgical treatments and further hospitalizations. #