Pelvic organ prolapse and urinary incontinence are common conditions in women that significantly diminish quality of life. With roughly 225,000-280,000 women requiring surgery each year in the United States alone, societal costs are over a billion dollars annually (1). While repair with synthetic mesh products have become the surgical treatment of choice, these meshes require very little premarket testing because they are based on previously approved abdominal wall hernia products (510K devices). Thus, there is little scientific data on the efficacy of meshes for gynecological surgery. Moreover, with the recent FDA warning citing large numbers of unreported complications in patients, there is growing concern about the use of gynaecological mesh, especially for transvaginal placement (2). Thus, there is a need to examine the ex-vivo properties of these meshes and relate them to their in-vivo function and outcomes for gynecological applications. Historically, stiffer mesh materials have been associated with increased rates of complications including erosions, infection, pain, and scarring. Based on poor initial clinical outcomes, companies have continued to alter their products and market them to clinicians as "improved" without much data to back these claims. Therefore, our objective was 2-fold: 1) to characterize three commonly used synthetic prolapse meshes, Gynecare (Ethicon), UltraPro (Ethicon) and Restorelle (Mpathy), prior to implantation by examining mesh porosity, architecture, and structural properties, and 2) to characterize the host response to mesh in a non-human primate model at 3 months following implantation based on histological appearance, passive structural properties and active contractile behavior of the mesh-tissue complex relative to sham controls. We hypothesize that stiffer meshes induce a stress-shielding response in vaginal tissues that results in inferior tissue incorporation and tissue function following implantation.
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