5 Safety

5 Safety

This section describes safety outcomes from the published literature that the committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.

5.1 Immediate postoperative complications were reported in 4% (20/278) of patients who had anterior prolapse repair with mesh and 4% (343/7643) of patients who had repair without mesh in a cohort study of 18,986 patients. Late postoperative complications were more common in patients who had a mesh repair compared with those who had a non-mesh repair (adjusted incidence rate ratio 3.15, 95% confidence interval [CI] 2.46 to 4.04) in the same study.

5.2 Mesh complications were reported in 12% (51/434) of patients who had a synthetic mesh repair at 2‑year follow‑up in a randomised controlled trial (RCT) of 865 patients. Surgical removal of the mesh was needed in 9% (37/434) of patients in the same study. Mesh complications were reported in less than 1% (2/368) of patients who had a biological graft repair and less than 1% (2/367) of patients who had a standard repair in an RCT of 735 patients. Surgical removal was needed in 3 of the 4 patients. Surgery for mesh complications was reported in 6% of patients who had a mesh repair in a cohort study of 27,809 patients.

5.3 Mesh exposure was reported in 12% (134/2,097) of patients who had a transvaginal permanent mesh repair in a systematic review of 4,023 patients at 1‑ to 3‑year review. Surgery for mesh exposure was reported in 8% (100/1,227) of patients in the same review. The overall rate of graft erosion (by meta-analysis of 110 studies) was 10% (95% CI 10 to 11%) of procedures in a systematic review of 126 studies. Mesh erosion was reported in 5% (32/677) of patients and vesicovaginal fistula with mesh extrusion was reported in less than 1% of patients (2/677) in a case series of 677 patients.

5.4 Serious adverse effects of any kind (excluding mesh complications) were reported in 8% (34/435) of patients who had a synthetic mesh repair and 7% (31/430) of patients who had a standard repair (p=0.73) at 1‑year follow‑up in the RCT of 865 patients. Serious adverse effects of any kind (excluding mesh complications) were reported in 10% (36/368) of patients who had a biological graft repair and 6% (23/367) of patients who had a standard repair (p=0.08) at 1‑year follow‑up in the RCT of 735 patients.

5.5 Bladder injury was more common in women who had a transvaginal permanent mesh repair than those who had a native tissue repair (relative risk [RR] 3.92, 95% CI 1.62 to 9.50, 11 RCTs, n=1,514, I2=0%, moderate-quality evidence) in the systematic review of 4,023 patients. Bowel injury was reported in 1 study in the same systematic review, and there was no evidence of a difference between the 2 groups (RR 3.26, 95% CI 0.13 to 78.81, n=169). Bladder injury and rectal damage were reported in 2% (11/677) and 1% (5/677) of patients respectively in a case series of 677 patients. In 2 patients, urinary tract injury was not recognised at the time of surgery and led to stone formation. One patient needed a laparotomy and removal of the mesh with resection of the bladder wall. Ureteric trauma was reported in 1 patient in the same study; this was treated by ureteroneocystotomy.

5.6 Bleeding more than 500 ml was reported in 2% (15/677) of patients in the case series of 677 patients. Vaginal or pelvic haematoma was reported in 6% (37/677) of patients in a case series of 677 patients. In 10 patients, major vaginal haematomas led to urinary retention or transformed into an abscess. Several of them needed to be drained transcutaneously. Perineal haematoma was reported in 3% (17/677) of patients in the same study.

5.7 Pelvic abscess was reported in 1% (4/677) of patients in the case series of 677 patients. One patient, with a history of intrauterine device inserted 30 years ago, had necrotising fasciitis. The patient developed signs of systemic toxicity 6 days after the prolapse repair. She was treated by fasciotomy and debridement but died after 18 days.

5.8 De novo stress urinary incontinence was more common in patients who had a transvaginal permanent mesh repair than in those who had a native tissue repair (RR 1.39, 95% CI 1.06 to 1.82, 12 RCTs, n=1,512, I2=0%, low-quality evidence) in the systematic review of 4,023 patients. Incontinence surgery admissions were more common after anterior repair with mesh than after anterior repair without mesh (adjusted incidence rate ratio 3.20, 95% CI 2.06 to 4.96) in a cohort study of 18,986 patients.

5.9 Urinary retention within 90 days was more common in patients who had a mesh repair than in those who had a repair without mesh (8% compared with 6%, risk ratio 1.33, 95% CI 1.18 to 1.51) in a cohort study of 27,991 patients.

5.10 The overall rate of dyspareunia (by meta-analysis of 70 studies) was 9% (95% CI 8 to 10%) of procedures in the systematic review of 126 studies. Pain and dyspareunia was reported in 2% (16/677) of patients in the case series of 677 patients.

5.11 As well as safety outcomes reported in the literature, specialist advisers are asked about anecdotal adverse events (events which they have heard about) and about theoretical adverse events (events which they think might possibly occur, even if they have never done so). For this procedure, specialist advisers did not describe any additional anecdotal or theoretical adverse events.

5.12 Sixteen commentaries from patients who had experience of this procedure were received, which were discussed by the committee.

  • National Institute for Health and Care Excellence (NICE)