The use of transvaginal mesh and biological graft in prolapse surgery did not improve outcomes of effectiveness, quality of life, or adverse events, and more than 1 in 10 women had a mesh complication, according to study results published in The Lancet.
The prolapse surgery pragmatic evaluation and randomized controlled trials (PROSPECT) compared outcomes of prolapsed repair involving either synthetic mesh inlays or biological grafts against standard repair in 35 centers in the United Kingdom.
“Our study showed that more than 30% of women who have prolapse surgery have a residual feeling of something coming down and more than 80% have at least one residual prolapse symptom, highlighting the poor short term outcomes of transvaginal anterior or posterior prolapse surgery with or without reinforcement,” the study authors noted. “New research should be aimed at finding and testing methods that will improve those outcomes.”
In the mesh trial, participants were randomly assigned to treatment with either standard repair alone (n=430) or mesh augmentation (n=435). In the graft trial, 367 participants received standard repair alone and 368 were treated with graft augmentation. The primary outcomes of the study were participant-reported prolapse symptoms from the Pelvic Organ Prolapse Symptom Score (POP-SS) and condition-specific quality-of-life scores measured at 1 year and 2 years.
The 1-year POP-SS did not differ substantially between the mesh and graft comparisons (standard, 5.4 vs mesh, 5.5 [mean difference, 0.00]; standard, 5.5 vs graft, 5.6 [mean difference, -0.15]). In addition, the mean prolapsed-related quality of life scores did not differ between the groups at 1 year (standard, 2.0 vs mesh, 2.2 [mean difference, 0.13]; standard, 2.2 vs graft, 2.4 [mean difference, 0.13]).
At 2 years, the mean POP-SS for the trial comparing standard repair with mesh augmentation was 4.9 vs 5.3 (mean difference, 0.32) and the mean for the trial comparing standard repair with graft augmentation was 4.9 vs 5.5 (mean difference, 0.32). The mean prolapsed-related quality of life score for the trial comparing standard repair with mesh augmentation at 2 years was 1.9 vs 2.2 (mean difference, 0.15), and the mean for the trial comparing standard repair with graft augmentation was 2.0 vs 2.2 (mean difference, 0.10).
In the mesh trial, serious adverse events, including infection, urinary retention, or dyspareunia or other pain, occurred in 7% of patients treated with standard repair and 8% treated with mesh (risk ratio, 1.08). In the graft trial, adverse events occurred in 6% of patients treated with standard repair and 10% treated with graft (risk ratio, 1.57).
Of the 434 women who were exposed to synthetic mesh, 12% developed a complication over 2 years.
“Although no evidence was apparent of differences between standard, mesh, or graft repair in other adverse effects up to 2 years after surgery, mesh use did result in the need for additional surgical procedures for exposures and extrusion in the first 2 years, which might be considered to be an unnecessary risk,” the authors concluded.
“This additional risk suggests that in the future mesh should only be used in the context of trials aimed at identifying benefit from modifying mesh type or insertion techniques, or in defined categories of high-risk women.”
- Glazener CMA, Breeman S, Elders A, et al. Mesh, graft, or standard repair for women having primary transvaginal anterior or posterior compartment prolapsed surgery: two parallel-group, multicentre, randomized, controlled trials (PROSPECT). Lancet. 2016. doi:10.1016/s0140-6736(16)31596-3