Animal experimental research assessing urogynecologic surgical mesh implants: Outcome measures describing the host response, a systematic review and meta-analysis.

AIM: Before the introduction of new biomaterials for prolapse surgery, animal studies on the host response are required. Unfortunately, large variation in study design hampers obtaining an overview of the safety and efficacy, and translation to clinical practice. Our aim is to systematically review the literature on all outcome measures describing the host response in animal studies assessing the biocompatibility of urogynecologic surgical mesh implants for prolapse surgery. Furthermore, by meta-analysis, we aim to assess the effect of implantation and compare this to control animals receiving sham surgery or native tissue repair. METHODS: We performed a systematic search from inception to August 2020. Since this is an explorative study we included original, controlled, and noncontrolled animal studies describing any host response to the implant. Quantitative outcome measures reported ≥10 times in ≥2 articles were eligible for meta-analysis. RESULTS: Fifty articles were included in the qualitative synthesis and 36 articles were eligible for meta-analysis. In total, 154 outcome measures were defined and classified into (1) histomorphology, (2) biomechanics and, (3) macroscopic morphology. Animals with vaginal implants demonstrated significantly increased M1 and M2 macrophages, MMP-2, neovascularization, TNF-α, and stiffness, and lower vaginal contractility compared to control animals. CONCLUSION: The host response significantly differs in animals after vaginal mesh implantation compared to control animals, both pro- and anti-inflammatory. However, we observed a paucity in the uniformity of reported outcomes. For future animal studies, we propose the development of a core outcome set, which ideally predicts the host response in women.

Morbidity of a Single Incision Transvaginal Mesh to Correct Apical Prolapse.

STUDY OBJECTIVE: To determine complications and related reintervention rates associated with use of the Uphold Vaginal Support System (Boston Scientific, Boston, MA) for symptomatic vaginal apical prolapse. DESIGN: A multicenter retrospective study. SETTING: Two teaching hospitals. PATIENTS: Fifty-nine women with symptomatic vaginal apical prolapse. INTERVENTION: Vaginal apical prolapse surgery using the Uphold Mesh Kit system with or without other concomitant procedures. MEASUREMENTS AND MAIN RESULTS: A chart review was performed, including the following parameters: perioperative and postoperative complications, repeat surgery, and recurrence rate. A total of 59 patients met the criteria for inclusion in the study. Bladder perforation occurred perioperatively in 1 patient. Postoperative voiding difficulties were observed in 16 patients (27.1%), including 9 women (15.2%) who left the hospital with an indwelling catheter in place. There were 5 cases (8.5%) of transient groin pain, all of which resolved spontaneously. One patient developed a vaginal hematoma. Nine women (15%) required reoperation, including 4 (6.7%) because of recurrent prolapse and 1 (2%) for pelvic pain considered related to the mesh. Three patients (5%) required release of a midurethral sling (MUS) that had been placed concomitantly with the Uphold system. Two patients (3%) required a MUS for de novo stress incontinence. CONCLUSION: Use of the Uphold Vaginal Support System for symptomatic vaginal apical prolapse was associated with a significant risk of obstructed micturition. In our study population, 15% required repeat surgery, mainly for recurrent pelvic organ prolapse and de novo stress urinary incontinence. No surgical-related complication resulted in long-term morbidity.