Symptomatic improvement after mesh removal: a prospective longitudinal study of women with urogynaecological mesh complications.

OBJECTIVE: To compare clinical characteristics and outcomes in patients undergoing excision of polypropylene urogynaecological mesh for pain, mesh exposure or both. DESIGN: Prospective, longitudinal cohort. SETTING: Academic tertiary referral centre. POPULATION: Women undergoing complete vaginal mesh excision for mesh exposure and/or pain. METHODS: Clinical and patient-reported outcomes assessing pain (visual analog scale, VAS), bother (Pelvic Floor Distress Inventory, PFDI) and functional impact (Pelvic Functional Impact Questionnaire, PFIQ) were collected at baseline, 6, 12 and 24 months after complete mesh excision. Outcomes were compared by mesh type (sling, prolapse [transvaginal or sacrocolpopexy mesh], both) and complication (pain, exposure, both). MAIN OUTCOME MEASURES: 'Much better' or 'Very much better' on Patient Global Impression of Improvement (PGI-I) up to 2 years after removal. RESULTS: Of 173 women, 48 underwent removal for pain, 27 for exposure and 98 for exposure plus pain. 'Moderate to severe' baseline symptoms were reported by 75%; the most prevalent and severe symptom was dyspareunia. Patients with pain alone were most bothered (PFDI median 234.2, interquartile range 83, P = 0.02) and had the highest functional impact (PFIQ median 181, interquartile range 138, P < 0.001). After excision, only 33.3% of women with pain alone reported 'improved' symptoms (PGI-I), versus 73.9% with exposure, 58.3% with exposure plus pain (P = 0.03) with no differences in PGI-I by mesh type. VAS scores decreased in all groups, but PFDI and PFIQ did not improve in pain patients. CONCLUSIONS: In women experiencing a pain complication after urogynaecological mesh insertion, mesh removal often does not improve symptoms. TWEETABLE ABSTRACT: Only 33% of women with pain complications have improved symptoms after urogynaecological mesh removal.

The impact of prolapse mesh on vaginal smooth muscle structure and function.

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. TWEETABLE ABSTRACT: Prolapse mesh affects vaginal smooth muscle.

Deterioration in biomechanical properties of the vagina following implantation of a high-stiffness prolapse mesh.

OBJECTIVE: To define the impact of prolapse mesh on the biomechanical properties of the vagina by comparing the prototype Gynemesh PS (Ethicon) to two new-generation lower stiffness meshes, SmartMesh (Coloplast) and UltraPro (Ethicon). DESIGN: A study employing a nonhuman primate model. SETTING: University of Pittsburgh, PA, USA. POPULATION: Forty-five parous rhesus macaques. METHODS: Meshes were implanted via sacrocolpopexy after hysterectomy and compared with 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 position of the blue orientation lines relative to the longitudinal axis of the vagina. The mesh-vaginal complex (MVC) was excised in toto after 3 months. MAIN OUTCOME MEASURES: Active mechanical properties were quantified as the contractile force generated in the presence of 120 mmol/l KCl. Passive mechanical properties (a tissue's ability to resist an applied force) were measured using a multiaxial protocol. RESULTS: Vaginal contractility decreased by 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 behaviour of the MVC was drastically reduced for Gynemesh PS (P = 0.003), but not for 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.

Vaginal degeneration following implantation of synthetic mesh with increased stiffness.

OBJECTIVE: To compare the impact of the prototype prolapse mesh Gynemesh PS with that of two new-generation lower stiffness meshes, UltraPro and SmartMesh, on vaginal morphology and structural composition. DESIGN: A mechanistic study employing a nonhuman primate model. SETTING: Magee-Womens Research Institute at the University of Pittsburgh. POPULATION: Parous rhesus macaques, with similar age, weight, parity and Pelvic Organ Prolapse-Questionnaire scores. METHODS: Following Institutional Animal Care Use Committee approval, 50 rhesus macaques were implanted with Gynemesh PS (n = 12), UltraPro with its blue line perpendicular to the longitudinal axis of vagina (n = 10), UltraPro with its blue line parallel to the longitudinal axis of vagina (n = 8) or SmartMesh (n = 8) via sacrocolpopexy following hysterectomy. Sham-operated animals (n = 12) served as controls. MAIN OUTCOME MEASURES: The mesh-vagina complex was removed after 12 weeks and analysed for histomorphology, in situ cell apoptosis, total collagen, elastin, glycosaminoglycan content and total collagenase activity. Appropriate statistics and correlation analyses were performed accordingly. RESULTS: Relative to sham and the two lower stiffness meshes, Gynemesh PS had the greatest negative impact on vaginal histomorphology and composition. Compared with sham, implantation with Gynemesh PS caused substantial thinning of the smooth muscle layer (1557 ± 499 µm versus 866 ± 210 µm, P = 0.02), increased apoptosis particularly in the area of the mesh fibres (P = 0.01), decreased collagen and elastin content (20%, P = 0.03 and 43%, P = 0.02, respectively) and increased total collagenase activity (135%, P = 0.01). Glycosaminoglycan, a marker of tissue injury, was highest with Gynemesh PS compared with sham and other meshes (P = 0.01). CONCLUSION: Mesh implantation with the stiffer mesh Gynemesh PS induced a maladaptive remodelling response consistent with vaginal degeneration.