Since the ban on the use of vaginal meshes in most countries, sacrocolpopexy has become the treatment of choice for pelvic organ prolapse. The purpose of the current study was to assess the safety and efficacy of a polypropylene mesh (Sacromesh®) used for sacrocolpopexy in the long term follow-up.

Between 2009 and 2023, an open-label multi-centered observational study was conducted to investigate patients’ treatment and functional outcome, to collect any complications following the placement of Sacromesh®, and to assess real-life use of the mesh. Pre-operative, operative and short term post-operative date was collected retrospectively from patients’ medical files while long term post-operative efficacy and quality of life data were collected prospectively. The primary endpoint for evaluating efficacy was the rate of re-intervention and safety was assessed by the rate of complications.

A total of 290 women were enrolled in the study with a mean follow-up of 5.9 ± 2.7 years, a mean age of 62.0 ± 9.5 years, a mean Body Mass Index (BMI) of 25.0 ± 3.7. Most patients (95.8%) had sacrocolpopexy for a cystocele-predominant prolapse. Thirty-one patients (10.9%) required reinterventions: 4.9% for de novo Stress Urinary Incontinence (SUI), 1.8% for prolapse recurrence, 1% for pain, 0.7% for vaginal erosion, 0.3% for bowel obstruction, 0.3% for sigmoid fistula and 0.3% for mesh infection. Of these complications, only 3 surgical reinterventions were directly related to the mesh and led to total mesh removal. Post-operative mean PFIQ-7 score was found to be 14.03 ± 24.7 (scale from 0 to 100), mean PFDI-20 score was e 53.53 ± 50.17 (scale from 0 to 300). Postoperative pain was assessed through a Visual Analogy Scale (VAS) with a mean score of 1.86 ± 7.39. No deaths or device deficiencies or Unanticipated Serious Device Effects (USADEs) were reported in the course of study follow-up.

As concerns the primary endpoint, only 3 surgical reinterventions (1.1% of total study population) in the present study were deemed definitely related to the device and led to total device removal. Device-related reintervention rate results are very favorable as compared to data reported in literature (2.2% in Fritel et al. 2022, 1.1% in the present study).
Concerning the PFIQ-7 score, most patients were not hindered in everyday life activities by either urinary, bowel or vaginal symptoms at any time during the follow-up extending up to 12 years. The PFDI-20 questionnaire showed that prolapse symptoms, colo-recto-anal distress and urinary distress symptoms were at optimal levels, with a mean score of 53.53 ± 50.17 (scale from 0 to 300). Postoperative pain Visual Analogic Score (VAS) proved that most patients had no pain.

The present study confirms the beneficial outcome of sacrocolpopexy with the Sacromesh® mesh in terms of safety and efficacy. Quality of life seems to be preserved in the long term.

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