Characterisation of clinical and newly fabricated meshes for pelvic organ prolapse repair

Abstract

Clinical meshes used in pelvic organ prolapse (POP) repair are predominantly manufactured from monofilament polypropylene (PP). Complications from the use of these meshes in transvaginal kits, including mesh exposure and pain, have prompted two public health notifications by the FDA. The aim of this study was to compare several clinical PP POP meshes to new fabricated POP meshes, knitted from alternative polymers, for their mechanical properties using standard and clinically relevant multi-axial testing methods. Five new meshes were warp knitted to different architectures and weights from polyamide and polyetheretherketone monofilaments. A composite mesh of a polyamide mesh incorporating a gelatin layer was also fabricated to enable the potential delivery of cells on these meshes. Meshes were assessed for their structural characteristics and mechanical properties, using uniaxial stiffness, permanent strain, bending rigidity and multi-axial burst strength methods. Results were compared to three clinical urogynaecological polypropylene meshes: Polyform®, Gynemesh(TM)PS, and IntePro®. New fabricated meshes were uniaxially less stiff (less than 0.24 N/mm and 1.20 N/mm in toe and linear regions, respectively) than the Gynemesh (0.48 N/mm and 2.08 N/mm in toe and linear regions, respectively) and IntePro (0.57 N/mm in toe region) clinical meshes, with the gelatin coated PA mesh exhibiting lower permanent strain than Polyform clinical mesh (8.1% vs. 23.5%). New meshes had lower burst stiffness than Polyform (less than 16.9 N/mm for new meshes and 26.6N/mm for Polyform). Within the new mesh prototypes, the PA meshes, either uncoated (4.7-5.7 μN m) or with gelatin coating (16.7 μN m) possessed lower bending rigidity than both Polyform and Gynemesh (46.2 μN m and 36.4 μN m, respectively). The new fabricated mesh designs were of similar architecture, but with some improved mechanical properties, compared to clinical POP meshes. Multi-axial analysis of new and clinical mesh designs provides greater discriminatory power in analysing mesh mechanical properties for clinical applications.