Fixation of light weight polypropylene mesh with n-butyl-2-cyanocrylate in pelvic floor surgery: Experimental design approach in sheep for effectiveness evaluation

Abstract

Objective. The aim of this study was to find a proper experimental design and to evaluate n-butyl-2-cyanoacrylate (Histoacryl) as a fixation method for a light-weight and large pore PP mesh (Synthetic PP Mesh-1) using the sheep as an animal model. Methods. Posterior vaginal implantation by means of episiotomy was used to implant 8 ewes which were evaluated macroscopically and histologically at 3 months (n = 4) and 6 months (n = 4) post-surgery. In previous pilot studies anterior vaginal implantation was evaluated, as well as different synthetic mesh materials, sizes and fixation methods (n = 1 to 3) during three weeks. In all cases a clinical evaluation of the animal was performed. Results. A reduction in the mesh size (Synthetic PP Mesh-1) together with precise application of the surgical glue Histoacryl to fix the mesh yielded significantly better histocompatibility results (P < 0.01) compared to larger size or other fixation methods. Conclusion. The combination of Synthetic PP Mesh-1 with Histoacryl offered a high degree of graft integration without vaginal ulceration and a minimal foreign body reaction, being the sheep a proper animal model to test these types of medical devices.