2021 FDA Science Forum
Developing Methods for Accelerated In-Vitro Aging and Testing Flexural Stiffness of Gynecological Surgical Mesh Implants
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Contributing OfficeCenter for Devices and Radiological Health
Abstract
Surgical mesh is a medical device that has been used for various biomedical applications. Surgical mesh had reasonable success in repair of hernia and stress urinary incontinence (SUI), however their use for the repair of pelvic organ prolapse (POP) resulted in high rates of mesh erosion, discomfort, and pain, and did not reduce the need for further surgery compared to native tissue repairs. The high rate of recurrence in case of POP repairs using transvaginal surgical meshes was attributed to high rates of infection due to the surgical technique, mismatch in mechanical properties of the mesh and the pelvic tissues, and post-implantation instability of the surgical mesh materials and their physical structure. The current FDA guidance for surgical mesh does not recommend test methods for aging or provide specific test outputs that should be reported in a PMA submission. This poster presents an aging method for polypropylene surgical mesh implants based on automated reactive accelerated aging (aRAA) systems to simulate and accelerate in vivo-like inflammatory conditions that uses hydrogen peroxide (H2O2) to generate reactive oxygen species. The decomposition kinetics of H2O2 were monitored using a two-electrode system at 85 °C. The oxidation of surgical mesh was monitored using microscopy and Fourier-transform infrared spectroscopy (FTIR). The effect of surface orientation and testing direction on the flexural stiffness of pristine and oxidized meshes were measured based on ASTM F3260 to help determine flexural stiffness acceptability criteria for surgical meshes used for treating POP.
