Uterine suspension using mesh (including sacrohysteropexy) to repair uterine 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 Mesh complications were reported in 3% (2/74) of women in the laparoscopic hysteropexy group (1 excision and 1 spontaneous resolution) and in 7% (5/77) of women in the vaginal mesh hysteropexy group (treated by excision in 3 and observation in 2) in a non-randomised comparative study of 151 patients. Tape erosion into the bladder occurred in 1 non-pregnant woman who had grade 3 uterine prolapse recurrence after open sacrohysteropexy, in a case series of 194 premenopausal women with uterine prolapse treated by pectineal ligament hysteropexy (PLH). Further treatment details were not reported. In a systematic review of surgery for women with apical prolapse including 183 women with uterine prolapse (2 randomised controlled trials [RCTs]) comparing abdominal sacrohysteropexy (open or laparoscopic approach) with vaginal hysterectomy and vault repair/support, evidence from 1 RCT (n=82) did not show a statistically significant difference between vaginal hysterectomy with vault support and abdominal sacrohysteropexy in the rate of mesh exposure (risk ratio [RR] 0.20, 95% confidence interval [CI] 0.01 to 4.04), or the need for repeat operation for mesh exposure (RR 0.20, 95% CI 0.01 to 4.04).

5.2 In the systematic review including 183 women with uterine prolapse, evidence from 1 RCT (n=82) did not show a statistically significant difference in the rate of bowel injury between vaginal hysterectomy with vault support and abdominal sacrohysteropexy (RR 3.00, 95% CI 0.13 to 71.56). Small bowel injuries were reported in 3% (2/74) of women in the laparoscopic hysteropexy group and bladder injuries were reported in 4% (3/77) of women in the vaginal mesh hysteropexy group, in the non-randomised comparative study of 151 women.

5.3 Bowel obstructions were reported in 2 women in a case series of 159 women treated by modified single-sheet mesh sacrohysteropexy. Both needed surgical re-intervention to release bowel adhesions. Adhesions were noted between bowel and non-peritonised mesh in less than 1% (3/507) of women who reported lower abdominal pain 4 to 8 months after surgery, in a case series of 507 women treated by laparoscopic hysteropexy. These were carefully divided. Damage to surrounding organs causing haemorrhage was reported in less than 1% (3/507) of women in the same study.

5.4 Infections were reported in 1 RCT, 1 non-randomised comparative study, and 1 case series included in a systematic review of 239 women. In the RCT, infections were reported as vault abscess during admission (2/41), infected implant needing surgery (2/41) and fever of unknown origin (3/41). In total, 17% (7/41) of women had an infection after sacrohysteropexy compared with 5% (2/41) in the vaginal hysterectomy group. The outcome was reported as wound infection and fever in the non-randomised comparative study. Three cases of infection (3/39) occurred in the hysterectomy followed by sacrocolpopexy group, and 1 (1/36) occurred in the sacrohysteropexy group. In the case series, 1 urinary tract infection (1/30) and 1 wound infection (1/30) were reported after sacrohysteropexy.

5.5 In the systematic review including 183 women with uterine prolapse, evidence from 1 RCT (n=82) did not show a statistically significant difference between vaginal hysterectomy with vault support and abdominal sacrohysteropexy in the need for a blood transfusion (RR 2.00, 95% CI 0.19 to 21.21).

5.6 Other serious adverse effects reported in the systematic review of 239 women included incisional hernia in 4 women and 1 intestinal occlusion by the mesh after sacrohysteropexy. Pulmonary embolism was reported in 2 women in the case series of 507 women treated by laparoscopic sacrohysteropexy.

5.7 Other complications including perineal infection in 3% (16/507) of women, urinary tract infections in 1% (6/507) and voiding difficulties in 2% (11/507) were reported in the case series of 507 women treated by laparoscopic sacrohysteropexy. In a case series of 245 patients, after 1 year, 2% of women had urinary retention needing treatment, 2% had de novo stress urinary incontinence, 5% had urgency, 5% developed de novo constipation and 5% reported de novo dyspareunia. Overactive bladder occurred in 6% (3/54) of women treated by robotic or laparoscopic sacrohysteropexy and in 18% (10/57) treated by open sacrohysteropexy in the non-randomised study of 111 women (median follow‑up of 30 months). One patient reported a feeling of traction in the abdomen that reduced after the mesh was partially removed several weeks after robotic sacrohysteropexy, in a case series of 100 women. The study also reported ileus (n=1), oedema of the right arm leading to temporary sensitive malfunction (n=1) and de novo stress urinary incontinence (n=13). All patients reported postoperative dragging pain, at the points where the mesh was fixed to the abdominal wall, in a case series of 28 women.

5.8 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: sacral discitis. They considered that the following were theoretical adverse events: risk related to sacral promontory mesh fixation (vascular damage and discitis) and risk of performing a hysterectomy after a hysteropexy.

5.9 Twenty one commentaries from patients who had experience of this procedure were received, which were discussed by the committee.