Infracoccygeal sacropexy using mesh 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 erosion at a median follow‑up of 13 months was reported in 0 to 21% of patients (median 7%, n=889 patients who had infracoccygeal sacropexy) in a systematic review of 7,054 patients who had had various types of surgery using mesh for uterine or vaginal vault prolapse. In a case series of 118 patients who had infracoccygeal sacropexy, mesh erosion happened up to 30 months after the procedure.

5.2 Reoperation for mesh erosion was needed in up to 17% of patients (median 7%, n=678 patients who had infracoccygeal sacropexy), in the systematic review of 7,054 patients with uterine or vaginal vault prolapse. In an RCT of 49 patients, 10% (2/21) of patients who had infracoccygeal sacropexy had reoperation for anterior vaginal wall erosion up to a mean of 17 months after the procedure. In the case series of 118 patients, 2% (2/118) of patients had reoperation for erosion and 3% (3/118) for a fistula during a 59‑month mean follow‑up. In a case series of 577 patients, reoperation was needed in 4% (21/486) of patients to remove the mesh, in 1 patient to loosen the mesh, in 2% (12/496) of patients for stress urinary incontinence, in less than 1% (2/496) for evacuation of an abscess and in 1 patient for persistent dysfunctional uterine bleeding up to 4 years after the procedure.

5.3 Blood loss during the procedure needing transfusion was reported in 0 to 2% of patients (n=383 patients who had infracoccygeal sacropexy) in the systematic review of 7,054 patients with uterine or vaginal vault prolapse.

5.4 Haematoma was reported in 1% of patients (n=655 patients who had infracoccygeal sacropexy) in a systematic review of 2,653 patients who had had various types of surgery using mesh for uterine or vaginal vault prolapse.

5.5 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 with uterine or vaginal vault prolapse.

5.6 Infection was reported in 0 to 9% of patients (n=698 patients who had infracoccygeal sacropexy) in the systematic review of 7,054 patients with uterine or vaginal vault prolapse, at a median follow‑up of 13 months. Pararectal abscess was reported in 1 patient who had infracoccygeal sacropexy in the systematic review of 2,653 patients with uterine or vaginal vault prolapse (timing not reported).

5.7 Gluteovaginal sinus formation 3 months after the procedure and rectocutaneous fistula 2 months after the procedure were each described in a case report, included in the review of 2,653 patients with uterine or vaginal vault prolapse.

5.8 Dyspareunia was reported in 2% of patients (n=655 patients who had infracoccygeal sacropexy) in the systematic review of 2,653 patients with uterine or vaginal vault prolapse, up to a mean follow‑up of 120 weeks.

5.9 Prolonged pain was reported in less than 1% of patients (4/655 patients who had infracoccygeal sacropexy) in the systematic review of 2,653 patients with uterine or vaginal vault prolapse up to a mean follow‑up of 120 weeks.

5.10 Lower urinary tract symptoms were reported in 0 to 6% of patients (n=143 patients who had infracoccygeal sacropexy) in a systematic review of 3,093 patients who had had various types of surgery using mesh for uterine prolapse. De novo urge urinary incontinence or bladder overactivity symptoms were reported in 9% (10/118) of patients and de novo stress urinary incontinence was reported in 6% (7/118) of patients in the case series of 118 patients.

5.11 De novo constipation after the procedure was reported in 6% (7/118) of patients in the case series of 118 patients.

5.12 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 anecdotal adverse events or theoretical adverse events.