Mesh-augmented transvaginal repair of recurrent or complex anterior pelvic organ prolapse in accordance with the SCENIHR opinion

Abstract

Introduction and hypothesis To evaluate the performance of mesh-augmented repair of anterior pelvic organ prolapse (POP) with or without apical vaginal wall involvement in women with recurrent or complex prolapse. Methods This multicenter cohort study included women undergoing surgery with Calistar S (Promedon, Argentina) for anterior POP between 2016 and 2018. The SCENIHR opinion was considered for patient selection, surgeon’s experience and choice of implant. Patients were prospectively invited to assess effectiveness and safety by anamnesis, validated questionnaires and pelvic examination. A composite endpoint defined by POP-Q ≤ 1, absence of a vaginal bulge symptom and repeated surgery for POP was used to define treatment success. Descriptive statistics were applied. McNemar or Wilcoxon signed rank tests were used as paired samples tests. The significance level was set at 5%. Results A total of 107 non-fertile women with a mean age of 70.6 years were enrolled. Ninety-three (86.9%) women presented with recurrent prolapse. The mean follow-up time was 18.5 months. Treatment success was achieved in 76% of cases according the composite endpoint, with 98% reaching POP-Q ≤ 1 and a significant improvement in quality of life (p < 0.001). Mesh exposure occurred in six (5.6%) patients, although none required further surgery. Four (3.7%) patients reported dyspareunia, and a single (0.9%) patient displayed a prominence due to mesh folding. Conclusions Mesh-augmented repair of anterior POP is effective and safe in women with recurrent or complex prolapse. Hence, in a select patient population, the benefits of mesh-augmented POP repair still outweigh the risks.

Predictors of Clinical Outcome in Women with Pelvic Organ Prolapse Who Underwent Transvaginal Mesh Reconstruction Surgery

“…Despite the Uphold system and the Perigee system are not available currently. However, some similar commercial kits, self-tailored meshes, and autologous fasciae remain in use for transvaginal POP reconstruction [9][10][11][12][13][14][15][16][17][18][19][20][21]. Thus, our results could provide as a guide for perioperative consultation, even in the era of native tissue repair.…”

“…Despite the above systems are not available in the market owing to the FDA warning [8]. However, some self-tailored vaginal mesh [9][10][11][12] and transvaginal mesh kits, such as Calistar system (Promedon, Argentine [13,14], Surelift system (Neomedic International, Terrassa, Spain [15]), Pelvimesh system (Herniamehs, Italy [16]), and Seratom ® PA system (Seratex ® PA B2 type, Serag-Wiessner KG, Naila, Germany [17]) are still in use. In the era of native tissue repair, autologous rectus fascia or fascia lata are used for transobturator or sacrospinous fixation [18][19][20][21].…”

Surgical treatment of advanced anterior wall and apical vaginal prolapse using the anchorless self-retaining support implant: long-term follow-up

“…Comparisons may be made with recently reported outcomes for other types of mesh that are still in use. In this respect, Naumann et al [ 24 ] reported outcomes with the Calistar S ® (Promedon, Cordoba, Argentina) implant. They reported an 18-month follow-up with a composite success rate of 76%, mesh erosion in 5.6%, and dyspareunia in 3.7% of the cases.…”

Quo Vadis Urogynecology 2020 – Innovative Treatment Concepts for Urinary Incontinence and Pelvic Organ Prolapse

“…Bei einer mittleren OP-Zeit von 38 min fanden sich keine intraoperativen Komplikationen oder postoperativen Schmerzsyndrome. Sechs Frauen zeigten eine vaginale Netzerosion, die jeweils konservativ mit einer lokalen Estrogenisierung behandelt wurde 26 .…”

“…With a mean operating time of 38 minutes, there were no intraoperative complications and no incidences of postoperative pain syndrome. Six women had vaginal mesh erosion, and all of them were treated conservatively with topical application of estrogen 26 .…”