Long term safety and efficacy assessment of the polypropylene mesh (Sacromesh®) in the treatment of pelvic organ prolapse by sacrocolpopexy

Schaller M1, Benelmir S1, Homa M2, Ramanah R1

Research Type

Clinical

Abstract Category

Pelvic Organ Prolapse

Abstract 627
Open Discussion ePosters
Scientific Open Discussion Session 105
Thursday 24th October 2024
14:40 - 14:45 (ePoster Station 4)
Exhibition Hall
Grafts: Synthetic Pelvic Organ Prolapse Retrospective Study Prolapse Symptoms Surgery
1. Besancon University Medical Centre, 2. Cousin Biotech
Presenter
Links

Poster

Abstract

Hypothesis / aims of study
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.
Study design, materials and methods
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.
Results
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.
Interpretation of results
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.
Concluding message
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.
References
  1. 1. Serious complications and recurrences after pelvic organ prolapse surgery for 2309 women in the VIGI-MESH registry. Fritel X, de Tayrac R, de Keizer J, Campagne-Loiseau S, Cosson M, Ferry P, Deffieux X, Lucot JP, Wagner L, Debodinance P, Saussine C, Pizzoferrato AC, Carlier-Guérin C, Thubert T, Panel L, Bosset PO, Nkounkou E, Ramanah R, et al. BJOG. 2022 Mar;129(4):656-663
  2. 2. Biomechanical interests of supra-cervical hysterectomy with sacrocolpopexy: first study using finite element modeling. Lallemant M, Vega A, Chambert J, Jacquet E, Ramanah R. Int Urogynecol J. 2021 Jun;32(6):1599-1602
  3. 3. Evaluating the morbidity and long-term efficacy of laparoscopic sacrocolpopexy with and without robotic assistance for pelvic organ prolapse. Lallemant M, Tresch C, Puyraveau M, Delplanque S, Cosson M, Ramanah R. J Robot Surg 2020 Nov 27
Disclosures
Funding Cousin Biotech Clinical Trial No Subjects Human Ethics Committee ID-RCB# 2019-A03155-52 Helsinki Yes Informed Consent Yes
14/11/2024 09:29:06