Sacrocolpopexy using mesh to repair vaginal vault prolapse

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 Incidence of death was not statistically significantly different between women treated by abdominal sacrocolpopexy (SCP) using mesh (0/503) and women treated using native tissue (less than 1% [1/582], odds ratio [OR] 0.14; 95% confidence interval [CI] 0.003 to 6.97) in the analysis of comparative studies reported in a systematic review and meta-analysis of 1,176 women. Postoperative admission to intensive care was not statistically significantly different between the SCP using mesh group (1% [3/561]) and the native tissue repair group (0/506, OR 4.64; 95% CI 0.42 to 50.6) in the analysis of comparative studies in the same systematic review.

5.2 Deep vein thrombosis or pulmonary embolism was not statistically significantly different between the SCP using mesh group (less than 1% [2/569]) and the native tissue repair group (less than 1% [1/599], OR 1.36; 95% CI 0.14 to 13.7) in the same analysis of comparative studies.

5.3 Mesh or suture complications were statistically significantly more frequent in women treated by SCP using mesh (4% [28/650]) than in women who had native tissue repair (1% [6/537], OR 3.26; 95% CI 1.62 to 6.56) in an analysis of comparative studies in the systematic review of 1,176 women. Mesh or suture complications were statistically significantly more frequent in women treated by SCP using mesh (4% [348/7,831]) than in women treated by native tissue repair (less than 1% [13/1,169], p<0.001) in an analysis of 40 SCP compared with 11 native tissue repair non-comparative studies. Mesh erosion was not statistically significantly different between robot-assisted sacrocolpopexy (RASC) and laparoscopic sacrocolpopexy (LSC; OR 1.82; 95% CI 0.51 to 6.45 [n=438], I²=0%, p=0.86) in a systematic review of 1,488 women. Mesh erosion was statistically significantly lower in women treated by RASC with supracervical hysterectomy (0%) than in women treated by RASC after total hysterectomy (14%, p=0.008) in 1 comparative study included in the same systematic review. Mesh erosion was reported in 1% (1/99) of women treated by LSC at 12 months and in 3% (2/85) at 60 months in a prospective case series of 101 women.

5.4 Reoperation rates were similar for women treated by SCP or sacrospinous ligament fixation (13% [6/46] compared with 16% [7/43], p=0.67) in an RCT (reported in the systematic review of 1,176 women) with follow-up of 6 to 66 months. Pooled reoperation rates were 7% (46/615) for SCP and 10% (51/511) for native tissue repair (OR 0.76, 95% CI 0.28 to 1.09) in 7 comparative studies from the same systematic review and meta-analysis. Pooled reoperation rates in non-comparative studies were 5% (367/7,218) for SCP and 3% (114/3,872) for native tissue repair (p=0.28) in the systematic review of 1,176 women. The reoperation rate was 3% (23/687) in women treated by RASC in the systematic review and meta-analysis of 1,488 women from 27 studies. A feeling of traction needing reoperation was reported in less than 1% (2/1,118) of the women treated by RASC in the same systematic review. Reoperation for stress urinary incontinence in women treated by LSC was reported in 15% (15/99) and 19% (16/85) of women at 12 and 60 months respectively in the prospective case series of 101 women. Reoperation rates in women treated by RASC were 2%, 5% and 10% at years 1, 3 and 6 respectively in a prospective case series of 70 women.

5.5 The vaginotomy rate in women treated by RASC was 1% (14/1,488) in the systematic review and meta-analysis of 1,488 women from 27 studies.

5.6 Urinary tract injury was not statistically significantly different in women treated by SCP using mesh (2% [20/1,068]) compared with women treated by native tissue repair (1% [9/1,108], OR 1.68; 95% CI 0.79 to 3.55) in 8 comparative studies from the systematic review of 1,176 women. Urinary tract injury was statistically significantly higher in women treated by SCP using mesh (2% [113/6,894]) compared with native tissue repair (1% [46/5,111], p<0.05) in the analysis of non-comparative studies from the same review. Bladder injury in women treated by RASC was 2% (26/1,488) in the systematic review of 1,488 women. Ureteral injury was less than 1% (1/1,488) in women from the same systematic review.

5.7 Bowel injury in women treated by RASC was less than 1% (4/1,488) in the systematic review of 1,488 women.

5.8 Stress incontinence in women who had not had it before and who were treated by LSC was 24% (24/99) and 38% (32/85) at 12 and 60 months respectively in the case series of 101 women. Postoperative voiding disorders occurred in 8% (8/99) and 13% (11/85) of women at 12 and 60 months respectively in the same patient group. Urge incontinence in women who had not had it before occurred in 2% (2/99) women at 12 months and in 8% (7/85) at 60 months. The detrusor muscle overactivity rate was 9% (15/165) in a case series of 165 women.

5.9 Dyspareunia was statistically significantly lower in women treated by SCP using mesh (5% [23/445]) than in women treated by native tissue repair (12% [46/384], OR 0.42; 95% CI 0.25 to 0.72) from the analysis of 5 comparative studies reported in the systematic review and meta-analysis of 1,176 women. The rate of dyspareunia was similar for SCP using mesh (12% [371/2,986]) and native tissue repair (9% [200/2,180]; p=0.48) in the analysis of non-comparative studies in the same systematic review. Dyspareunia in women who had not had this before who were treated by LSC was 2% (1/47) and 24% (10/41) at 12 and 60 months respectively in the prospective case series of 101 women.

5.10 Rectocele and cystocele incidence in women who had not had these before and who were treated by LSC was 12% (16/138) and 8% (11/183) respectively at 8-year follow-up in the case series of 165 women.

5.11 Infection rates were not statistically significantly different between women treated by SCP using mesh (3% [17/676]) and women treated by native tissue repair (1% [9/617] OR 2.01; 95% CI 0.91 to 4.45) in the analysis of comparative studies reported in the systematic review and meta-analysis of 1,176 women. Infection rates were not statistically significantly different between women treated by mesh SCP (2% [114/5,519]) and women treated by native tissue repair (12% [558/4,743], p=0.6) in the analysis of non-comparative studies for the same systematic review. Abscess formation in women treated by RASC was less than 1% (3/1,118) in the systematic review of 1,488 women. Peritonitis caused by bowel injury was reported in less than 1% (2/1,118) of women in the same review.

5.12 Bleeding rates were not statistically significantly different between women treated by SCP using mesh (3% [43/1,317]) and women treated by native tissue repair (2% [37/1,863] OR 1.00; 95% CI 0.63 to 1.59) in the comparative studies reported in the systematic review of 1,176 women. Bleeding rates were statistically significantly lower in women treated by SCP using mesh (2% [128/6,555]) than in women treated by native tissue repair (5% [367/7,044], p=0.05) in the analysis of non-comparative studies in the same systematic review.

5.13 Ileus or small bowel obstruction was statistically significantly higher in women treated by SCP using mesh (2% [16/814]) than in women treated by native tissue repair (less than 1% [2/780], OR 9.45; 95% CI 3.39 to 26.4) in the analysis of comparative studies reported in the systematic review of 1,176 women. Ileus or small bowel obstruction was also statistically significantly higher in women treated by SCP using mesh (3% [137/4,168]) than in women treated by native tissue repair (less than 1% [3/1,449], p<0.01) in the analysis of non-comparative studies for the same systematic review. Bowel obstruction in women treated by RASC was less than 1% (5/1,118) in the systematic review of 1,488 women. Postoperative constipation in women treated by LSC was 1% (1/99) and 5% (4/85) at 12 and 60 months respectively, in the case series of 101 women.

5.14 Lumbosciatica pain was reported in 3% (5/165) of women treated by LSC in the case series of 165 women.

5.15 Intraoperative complication rates were not statistically significantly different between women treated by RASC and women treated by LSC (OR 1.05; 95% CI 0.52 to 2.12 [n=443], I²=0%, p=0.94) in the systematic review of 1,488 women. Surgical conversion to open surgery was also not statistically significantly different between the RASC and LSC treatment groups (OR 0.89; 95% CI 0.25 to 3.19 [n=443], I²=0%, p=0.72). The incidence of all postoperative complications was not statistically significant between RASC and LSC (OR 1.85; 95% CI 0.96 to 3.75 [n=350], I²=37%, p=0.18) and this was also true for severe postoperative complications (of grade 3 or higher; OR 0.56; 95% CI 0.36 to 2.83 [n=430], I²=24%, p=0.73).

5.16 In addition to 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). The anecdotal adverse events reported for the procedure were osteomyelitis of the sacrum and haemorrhage from left iliac vein.

5.17 Fourteen commentaries from women who had experience of this procedure were received, which were discussed by the committee.