Infracoccygeal sacropexy 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 Mesh erosion was reported in 11 studies (n=889) of infracoccygeal sacropexy, with rates of 0 to 21% of patients (median 7%), in a systematic review of 7,054 patients. Reoperation for mesh erosion was needed in up to 17% of patients (median 7%, n=678). Mesh erosion was reported in 8% of patients treated by infracoccygeal sacropexy (n=655) in a systematic review of 2,653 patients. Vaginal tape exposure was reported in 10% (50/496) of patients in a case series of 577 patients and surgery to remove the tape was reported in 4% (21/496) of patients. Reoperation for anterior vaginal wall erosion was reported in 10% (2/21) of patients treated by infracoccygeal sacropexy and 8% (2/24) of patients treated by sacrospinous suspension, in an RCT of 49 patients.

5.2 Blood loss needing transfusion was reported in 7 studies (n=383) of infracoccygeal sacropexy, with rates ranging from 0 to 2%, in the systematic review of 7,054 patients.

5.3 Haematoma was reported in 1% of patients treated by infracoccygeal sacropexy (n=655) in the systematic review of 2,653 patients. Haematoma was reported in 3% (4/118) of all patients in the case series of 118 patients with vaginal cuff or utero-vaginal prolapse; 1 patient needed surgical evacuation and blood transfusion.

5.4 Organ damage during the procedure was reported in 0 to 3% of patients (n=684 patients who had infracoccygeal sacropexy) in the systematic review of 7,054 patients. Bladder injury was reported in 2 patients treated by infracoccygeal sacropexy and 1 patient treated by sacrospinous suspension in the RCT of 49 patients.

5.5 Infection was reported in 8 studies (n=698) of infracoccygeal sacropexy, with rates of 0 to 9%, in the systematic review of 7,054 patients. Pararectal abscess was reported in 1 patient treated by infracoccygeal sacropexy in the systematic review of 2,653 patients. Abscess or fistula was reported in 3% (3/118) of patients in the case series of 118 patients; all 3 patients needed surgery. Gluteovaginal sinus formation 3 months after infracoccygeal sacropexy and rectocutaneous fistula 2 months postoperatively were each described in a case report, included in the review of 2,653 patients.

5.6 Dyspareunia was reported in 2% of patients treated by infracoccygeal sacropexy (n=655) in the systematic review of 2,653 patients. De novo dyspareunia was reported in 7% (25/348) of sexually active patients in the case series of 577 patients.

5.7 Prolonged pain was reported in less than 1% of patients (4/655) who had infracoccygeal sacropexy in the systematic review of 2,653 patients.

5.8 De novo urinary urge incontinence or bladder overactivity symptoms were reported in 9% (10/118) of patients and de novo urinary stress incontinence was reported in 6% (7/118) of patients in the case series of 118 patients. De novo urinary symptoms were reported in 6% (29/496) of patients in the case series of 577 patients.

5.9 De novo constipation after the procedure was reported in 6% (7/118) of patients in the case series of 118 patients. Constipation was reported in 2% (2/92) of patients treated by infracoccygeal sacropexy and 9% (9/98) of patients treated by abdominal sacrocolpopexy (p=0.039) in the non-randomised comparative study of 190 patients.

5.10 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 did not list any additional anecdotal or theoretical adverse events.

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