Objective Define the impact of prolapse mesh on the biomechanical properties of the vagina by comparing the prototype Gynemesh PS (Ethicon, Somerville, NJ) to 2 new generation lower stiffness meshes, SmartMesh (Coloplast, Minneapolis, MN) and UltraPro (Ethicon). Design A study employing a non-human primate model Setting University of Pittsburgh Population 45 parous rhesus macaques Methods Meshes were implanted via sacrocolpexy after hysterectomy and compared to Sham. Because its stiffness is highly directional UltraPro was implanted in two directions: UltraPro Perpendicular (less stiff) and UltraPro Parallel (more stiff), with the indicated direction referring to the blue orientation lines. The mesh-vaginal complex (MVC) was excised en toto after 3 months. Main Outcome Measures Active mechanical properties were quantified as contractile force generated in the presence of 120 mM KCl. Passive mechanical properties (a tissues ability to resist an applied force) were measured using a multi-axial protocol. Results Vaginal contractility decreased 80% following implantation with the Gynemesh PS (p=0.001), 48% after SmartMesh (p=0.001), 68% after UltraPro parallel (p=0.001) and was highly variable after UltraPro perpendicular (p =0.16). The tissue contribution to the passive mechanical behavior of the MVC was drastically reduced for Gynemesh PS (p=0.003) but not SmartMesh (p=0.9) or UltraPro independent of the direction of implantation (p=0.68 and p=0.66, respectively). Conclusions Deterioration of the mechanical properties of the vagina was highest following implantation with the stiffest mesh, Gynemesh PS. Such a decrease associated with implantation of a device of increased stiffness is consistent with findings from other systems employing prostheses for support.

BACKGROUND Although synthetic mesh is associated with superior anatomic outcomes for the repair of pelvic organ prolapse, the benefits of mesh have been questioned because of the relatively high complication rates. To date, the mechanisms that result in such complications are poorly understood, yet the textile characteristics of mesh products are believed to play an important role. Interestingly, the pore diameter of synthetic mesh has been shown to impact the host response after hernia repair greatly, and such findings have served as design criteria for prolapse meshes, with larger pores viewed as more favorable. Although pore size and porosity are well-characterized before implantation, the changes in these textile properties after implantation are unclear; the application of mechanical forces has the potential to greatly alter pore geometries in vivo. Understanding the impact of mechanical loading on the textile properties of mesh is essential for the development of more effective devices for prolapse repair. OBJECTIVE The objective of this study was to determine the effect of tensile loading and pore orientation on mesh porosity and pore dimensions. STUDY DESIGN In this study, the porosity and pore diameter of 4 currently available prolapse meshes were examined in response to uniaxial tensile loads of 0.1, 5, and 10 N while mimicking clinical loading conditions. The textile properties were compared with those observed for the unloaded mesh. Meshes included Gynemesh PS (Ethicon, Somerville, NJ), UltraPro (Artisyn; Ethicon), Restorelle (Coloplast, Minneapolis, MN), and Alyte Y-mesh (Bard, Covington, GA). In addition to the various pore geometries, 3 orientations of Restorelle (0-, 5-, 45-degree offset) and 2 orientations of UltraPro (0-, 90-degree offset) were examined. RESULTS In response to uniaxial loading, both porosity and pore diameter dramatically decreased for most mesh products. The application of 5 N led to reductions in porosity for nearly all groups, with values decreasing by as much as 87% (P < .05). On loading to 10 N of force, nearly all mesh products that were tested were found to have porosities that approached 0% and 0 pores with diameters >1 mm. CONCLUSION In this study, it was shown that the pore size of current prolapse meshes dramatically decreases in response to mechanical loading. These findings suggest that prolapse meshes, which are more likely to experience tensile forces in vivo relative to hernia repair meshes, have pores that are unfavorable for tissue integration after surgical tensioning and/or loading in urogynecologic surgeries. Such decreases in pore geometry support the hypothesis that regional increases in the concentration of mesh leads to an enhanced local foreign body response. Although pore deformation in transvaginal meshes requires further characterization, the findings presented here provide a mechanical understanding that can be used to recognize potential areas of concern for complex mesh geometries. Understanding mesh mechanics in response to surgical and...

Introduction and hypothesis The use of polypropylene meshes for surgical repair of pelvic organ prolapse (POP) has been limited by complications, including mesh exposure, encapsulation, and pain. Numerous products are available with a wide array of textile and structural properties. It is thought that complications may be related, in part, to mesh structural properties. However, few descriptions of these properties exists to directly compare products. The aim of this study was to determine the textile and structural properties of five commonly used prolapse mesh products using a ball-burst failure protocol. Methods Porosity, anisotropic index, and stiffness of Gynemesh PS (n=8), the prototype polypropylene mesh for prolapse repair, was compared with four newer-generation mesh produces: UltraPro (n=5), SmartMesh (n=5), Novasilk (n=5), and Polyform (n=5). Results SmartMesh was found to be the most porous, at 78 %±1.4 %. This value decreased by 21 % for Gynemesh PS (p<0.001), 14 % for UltraPro and Novasilk (p<0.001), and 28 % for Polyform (p<0.001). Based on the knit pattern, SmartMesh and Polyform were the only products considered to be geometrically isotropic, whereas all other meshes were anisotropic. Comparing the structural properties of these meshes, Gynemesh PS and Polyform were the stiffest: 60 % and 42 % stiffer than SmartMesh (p<0.001) and Novasilk (p<0.001), respectively. However, no significant differences were found between these two mesh products and UltraPro. Conclusions Porosity, anisotropy, and biomechanical behavior of these five commonly used polypropylene mesh products were significantly different. This study provides baseline data for future implantation studies of prolapse mesh products.

Objective To evaluate the impact of prolapse meshes on vaginal smooth muscle structure (VaSM) and function, and to evaluate these outcomes in the context of the mechanical and textile properties of the mesh. Design Three months following the implantation of three polypropylene prolapse meshes with distinct textile and mechanical properties, mesh tissue explants were evaluated for smooth muscle contraction, innervation, receptor function, and innervation density. Setting Magee-Womens Research Institute at the University of Pittsburgh. Population Thirty-four parous rhesus macaques of similar age, parity, and pelvic organ prolapse quantification (POP–Q) scores. Methods Macaques were implanted with mesh via sacrocolpopexy. The impact of Gynemesh™ PS (Ethicon; n = 7), Restorelle® (Coloplast; n = 7), UltraPro™ parallel and UltraPro™ perpendicular (Ethicon; n = 6 and 7, respectively) were compared with sham-operated controls (n = 7). Outcomes were analysed by Kruskal–Wallis ANOVA, Mann–Whitney U–tests and multiple regression analysis (P < 0.05). Mean outcome measures Vaginal tissue explants were evaluated for the maximum contractile force generated following muscle, nerve, and receptor stimulation, and for peripheral nerve density. Results Muscle myofibre, nerve, and receptor-mediated contractions were negatively affected by mesh only in the grafted region (P < 0.001, P = 0.002, and P = 0.008, respectively), whereas cholinergic and adrenergic nerve densities were affected in the grafted (P = 0.090 and P = 0.008, respectively) and non-grafted (P = 0.009 and P = 0.005, respectively) regions. The impact varied by mesh property, as mesh stiffness was a significant predictor of the negative affect on muscle function and nerve density (P < 0.001 and P = 0.013, respectively), whereas mesh and weight was a predictor of receptor function (P < 0.001). Conclusions Mesh has an overall negative impact on VaSM, and the effects are a function of mesh properties, most notably, mesh stiffness.

Introduction and hypothesis Parity is the leading risk factor for the development of pelvic organ prolapse. To assess the impact of pregnancy and delivery on vaginal tissue, researchers commonly use nonhuman primate (NHP) and rodent models. The purpose of this study was to evaluate the ewe as an alternative model by investigating the impact of parity on the ewe vaginal mechanical properties and collagen structure. Methods Mechanical properties of 15 nulliparous and parous ewe vaginas were determined via uniaxial tensile tests. Collagen content was determined by hydroxyproline assay and collagen fiber thickness was analyzed using picrosirius red staining. Outcome measures were compared using Independent samples t or Mann–Whitney U tests. ANOVA (Gabriel’s pairwise post-hoc test) or the Welch Alternative for the F-ratio (Games Howell post-hoc test) was used to compare data with previously published NHP and rodent data. Results Vaginal tissue from the nulliparous ewe had a higher tangent modulus and tensile strength compared with the parous ewe (p < 0.025). The parous ewe vagina elongated 42 % more than the nulliparous ewe vagina (p = 0.015). No significant differences were observed in collagen structure among ewe vaginas. The tangent modulus of the nulliparous ewe vagina was not different from that of the NHP or rodent (p = 0.290). Additionally, the tangent moduli of the parous ewe and NHP vaginas did not differ (p = 0.773). Conclusions Parity has a negative impact on the mechanical properties of the ewe vagina, as also observed in the NHP. The ewe may serve as an alternative model for studying parity and ultimately prolapse development.

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The objective of this study was to elucidate the normal functional adaptations of the cervix in pregnancy. Utilizing a Long-Evans rodent model, the cervix was divided into distal and proximal portions for virgin, mid-pregnant, and four weeks postpartum animals. The quasi-linear viscoelastic theory describes the elastic and viscous behavior of the cervix. A hydroxyproline assay was used to measure collagen content. The nonlinearity of the elastic response significantly increased throughout the entire cervix during pregnancy when compared to virgin samples (p < 0.05) and was similar to virgin samples postpartum. All viscous behavior, except for the short-term relaxation of the proximal cervix, significantly differed for pregnant specimens (p < 0.05) and remained similar to pregnant samples postpartum. Collagen content was found to increase by mid-pregnancy only in the proximal cervix when compared to virgin. Distal and proximal portions, however, were found to differ in collagen content at all time points (p < 0.05). This study finds that the cervix becomes elastically stiffer with increasing strain and exhibits increased viscous behavior during pregnancy, with incomplete recovery postpartum. These alterations allow for quick dissipation of loads, and are likely related to altered matrix organization and porosity reported by others.

Exposure following pelvic organ prolapse repair has been observationally associated with wrinkling of the implanted mesh. The purpose of this study was to quantify the impact of variable boundary conditions on the out-of-plane deformations of mesh subjected to tensile loading. Using photogrammetry and surface curvature analyses, deformed geometries were accessed for two commercially available products. Relative to standard clamping methods, the amount of out-of-plane deformation significantly increased when point loads were introduced to simulate suture fixation in-vivo. These data support the hypothesis that regional increases in the concentration of mesh potentially enhance the host’s foreign body response, leading to exposure.