Vaginal mesh kits linked with higher re-operation rates

Chicago-Although overall complication rates are similar after traditional surgery, sacral colpopexy, or vaginal mesh kit repair for apical vaginal prolapse, the mesh kit procedures are associated with higher total reoperation rates due to a higher rate of surgical intervention for managing complications, according to a meta-analysis undertaken by researchers at the Cleveland Clinic.

The study, presented at the American Urogynecologic Society annual scientific meeting, included data from 16,891 women enrolled in 111 studies. Fifty-four studies reported outcomes for about 7,800 women who underwent traditional vaginal procedures, including McCall culdoplasty or uterosacral ligament, sacrospinous ligament, or iliococcygeus fascial suspension. There were 51 studies providing outcomes on open and laparoscopic sacral colpopexy in about 5,600 women, but only 24 published studies reporting on about 3,400 women who underwent a mesh kit procedure.

The rate of reoperation for prolapse recurrence was lower in the vaginal mesh kit group than in both traditional surgery and sacral colpopexy (1.3% vs. 3.9% and 2.3%), but the mesh kit group had a total reoperation rate of 8.5% compared with 5.8% for traditional surgery and 7.1% for sacral colpopexy. The highest reoperation rate in the mesh kit group occurred even though it had the shortest mean follow-up period. Average duration of follow-up after mesh kit surgery was only 17.1 months compared with 26.5 months for sacral colpopexy and 32.6 months for traditional surgery, reported first author Gouri B. Diwadkar, MD, a urogynecology and pelvic reconstructive surgery fellow at the Cleveland Clinic working under the direction of John Jelovsek, MD, and colleagues.

"The findings of this meta-analysis looking at reoperations for prolapse recurrence and complications support the use of the traditional surgical approaches over these 'cutting-edge' mesh kits. However, data from further follow-up in more patients are needed to more definitively characterize the outcomes after vaginal mesh kit repairs."

Complication rates

The study was undertaken to address the absence of any meta-analysis comparing these three approaches for surgical repair of apical vaginal prolapse. Studies were identified via a search of the English literature and encompassed the period from January 1985 to January 2008. To be included in the meta-analysis, a study had to describe complication, recurrence, or reoperation rates, enroll at least 50 subjects, and report follow-up of at least 3 months. Both randomized, controlled trials and observational studies were included.

Complications reported in each paper were classified using the Dindo grading system, which is a validated system for grading complications based on the invasiveness of the intervention used for management.

Grade I describes complications treated with antiemetic, antipyretic, or analgesic medication. Grade II includes complications managed with other pharmacologic treatment or blood transfusion. Grade III complications require surgical management and are further divided as to whether general anesthesia is (IIIb) or is not (IIIa) required. Grade IV complications are life-threatening events requiring intensive care management, and fatalities are categorized as grade V.

Total complication rates ranged from 14.5% in the mesh kit group to 17.1% in the sacral colpopexy group. Grade IV and V complications occurred only in the traditional surgery group, each at a rate of 0.1%.

The traditional surgeries were associated with the highest rates of grade I and II complications, followed by sacral colpopexy and then the mesh kit group. Rates of grade IIIa complications were ≤1.3% across all groups, but grade IIIb complications occurred at a rate of 7.2% in the mesh kit group compared with 4.8% for sacral colpopexy and 1.9% for traditional surgery.

"The higher rate of grade IIIb complications associated with the mesh kit repairs primarily reflected a 5.8% rate of mesh erosion and infection in this group, and the mesh kit repair group also had a slightly higher rate of fistula. The visceral injury rate was highest in the sacral colpopexy group, but generally, complications associated with these procedures and traditional surgery could be managed with medications or an in-office procedure," Dr. Diwadkar said.

One of the co-authors on this study has received grant/research support from American Medical Systems.