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.

Mesh erosion

Abdominal sacrocolpopexy with concomitant hysterectomy

5.1 The risk of mesh erosion varied across 4 studies on abdominal sacrocolpopexy with concomitant hysterectomy to repair uterine prolapse included in a systematic review.

  • Mesh erosion was reported in 4% (1/23) of women treated by hysterectomy with concomitant sacrocolpopexy in a randomised controlled trial of 47 women available as a conference abstract (mean follow‑up 33 months).

  • In a non-randomised comparative study of 75 women, mesh erosion occurred in 8% (3/39) of women treated by hysterectomy with concomitant sacrocolpopexy and in no women (0/36) in the sacrohysteropexy group (mean follow‑up 51 months); all women with mesh erosion needed further surgery.

  • In another non-randomised comparative study of 88 women, erosion rates of 11% (8/76) were reported in women treated by total hysterectomy with concomitant sacrocolpopexy and in 4% (1/28) of women treated by supracervical hysterectomy with concomitant sacrocolpopexy (median follow‑up 4 months); 4 of the 8 women with mesh erosion needed further surgery.

  • In a case series of 324 women, 7% (7/101) of women reported mesh erosion after hysterectomy with concomitant sacrocolpopexy at a median follow‑up of 8.4 months (range 1.4 to 13 months).

5.2 In a retrospective non-randomised comparative study of 179 women, mesh erosion was reported in 6.5% (5/74) of women in the hysterectomy with concomitant sacrocolpopexy group, in 5.9% (3/51) of women in the sacrohysteropexy group and in 7.4% (4/54) of women in the sacrocolpopexy group with previous hysterectomy at a mean follow‑up 57 months. The time to mesh erosion ranged from 2 to 66 months. Four erosions were asymptomatic and 5 presented with vaginal bleeding, associated with dyspareunia in 2 women and infection in 3 women. In all women, surgery was needed to remove the mesh because conservative management did not work.

5.3 In a case-control study of 336 women treated by abdominal sacrocolpopexy (ASC n=43, control n=147) or vaginal mesh procedure (VMP n=41, control n=105) with concomitant hysterectomy, concomitant hysterectomy was associated with mesh extrusion among women who had ASC (odds ratio [OR], 3.18; 95% confidence interval [CI] 1.27 to 7.93, p=0.01) and VMP (OR 3.72, 95% CI 1.20 to 11.54, p=0.02).

5.4 In a retrospective non-randomised comparative study of 292 women treated by ASC (74 with concomitant hysterectomy, 218 with previous hysterectomy), the rates of mesh exposure were lower in women with previous hysterectomy (mesh erosion 53% [10/19] versus no erosion 76% [208/273], p=0.03) at a median follow‑up of 42 months. Also, the study found that concomitant hysterectomy (mesh erosion 47% [9/19] versus no erosion 24% [65/273], p=0.03) or 3 or more additional procedures (mesh erosion 32% [6/19] versus no erosion 11% [31/273], p=0.02) increased the risk of mesh exposure.

Robotic assisted sacrocolpopexy with concomitant hysterectomy

5.5 Mesh erosion rate after robotic assisted sacrocolpopexy (RASC) with a concomitant hysterectomy or RASC alone was not significantly different (2.7% [3/112] versus 5.1% [6/118]; p=0.50) in a retrospective non-randomised comparative study of 230 women at 6‑week follow‑up. The 2.7% (3/79) of mesh exposures in the hysterectomy group were associated with total hysterectomy and none with supracervical hysterectomy (n=33), this difference was not significant (p=0.50). In another retrospective non-randomised comparative study, there was a mesh exposure rate of 14% (8/57) in the combined RASC with total hysterectomy group compared with 0% (0/45) in the RASC with supracervical hysterectomy group (p<0.01) at 3‑month follow‑up. All erosions occurred at the vaginal apex.

Laparoscopic sacrocolpopexy with concomitant hysterectomy

5.6 Mesh erosion rates were higher in women having conventional laparoscopic sacrocolpopexy (LSC) with concomitant total vaginal hysterectomy (TVH) compared with both robotic or conventional sacrocolpopexy after hysterectomy (23% [13/57] versus 5% [5/110]; p=0.003) and robotic LSC with supracervical hysterectomy (23% [13/57] versus 5% [1/21]; p=0.984) in a retrospective cohort study of 188 women (mean follow‑up of 20 weeks). In multivariate regression analysis, the odds ratio of erosion for TVH done at the same time as sacrocolpopexy was 5.67 (95% CI 1.88 to 17.10; p=0.002) compared with sacrocolpopexy with concomitant hysterectomy.

5.7 Mesh exposure was more common when the vaginal cuff was opened, either in the course of hysterectomy or during vaginal attachment of mesh in women with a previous hysterectomy (4.9% [10/205] versus 0.5% [1/185]; relative risk [RR] 9.0; p=0.012) in a retrospective non-randomised comparative study of 390 women at a median follow‑up 26 weeks. In women who had a concomitant hysterectomy, a higher mesh exposure rate was seen in open-cuff hysterectomy (TVH or laparoscopically assisted vaginal hysterectomy [LAVH]) compared with supracervical hysterectomy (4.9% [9/185] versus 0% [0/92], p=0.032). Mesh exposure was more common when the mesh was sutured laparoscopically compared with transvaginally in women treated by open-cuff hysterectomy (14.3% [5/35] versus 2.7% [4/150]; relative risk, 5.4; p=0.013). There was no difference in exposure rates between TVH and LAVH groups (6.8% [4/59] versus 4% [5/126]; p=0.469).The rate of mesh complications was not significantly different among women who had TVH with LSC compared with women who had laparoscopic supracervical hysterectomy (LSCH) with LSC (1.6% [2/123] versus 1.7% [1/59]; p=1.0) in a retrospective non-randomised comparative study of 182 women with a median prospective follow‑up of 9 months.

5.8 Extrusion of permanent suture was more common in women treated by LSCH with LSC compared with women treated by TVH with LSC (5.6% [13/233] versus 0.6% [1/157]; relative risk, 8.8; p=0.010) in a retrospective cohort study of 390 women. Most of these extrusions were asymptomatic and were managed non-surgically. The rate of suture erosion was not significantly different among women who had TVH with LSC compared with women who had LSCH with LSC (1% versus 2%; p=1.0) in the retrospective non-randomised comparative study of 182 women with a median prospective follow‑up of 9 months.

Other complications

5.9 Wound infection was reported in 8% (3/39) of women treated by hysterectomy with concomitant sacrocolpopexy in the non-randomised comparative study of 75 women included in the systematic review.

5.10 The presence of granulation tissue was not significantly different among women who had TVH with LSC compared with women who had LSCH with LSC (10% versus 7%; p=0.6) in the retrospective non-randomised comparative study of 182 women with a median prospective follow‑up of 9 months. This was treated in the operating room.

5.11 Peri-vesical haematoma was reported in 5% (2/36) of women treated by sacrohysteropexy and 10% (4/39) of women who had hysterectomy with concomitant sacrocolpopexy in the non-randomised comparative study of 75 women included in the systematic review. The time of occurrence and further details were not reported.

5.12 Incisional hernia was reported in 5% (2/36) of women treated by sacrohysteropexy and 2% (1/39) of women who had hysterectomy with concomitant sacrocolpopexy in the non-randomised comparative study of 75 women included in the systematic review.

5.13 Severe abdominal pain because of bowel obstruction was reported in 1 patient in the LSCH+LSC group (n=59) in the non-randomised comparative study of 182 women. This was managed by small bowel resection and re-anastomosis of the bowel. The patient recovered completely and there was no evidence of mesh exposure.

5.14 Voiding dysfunction was reported in 11% (4/36) of women treated by sacrohysteropexy and 2% (1/39) of women who had hysterectomy with concomitant sacrocolpopexy in the non-randomised comparative study of 75 women included in the systematic review.

5.15 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). For this procedure, specialist advisers listed the following anecdotal adverse event: osteomyelitis because of vagina being opened and inserting mesh.

5.16 Six 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)