Host reaction to vaginally inserted collagen containing polypropylene implants in sheep - 17/12/14

Doi : 10.1016/j.ajog.2014.11.008

Andrew Feola, PhD ^a,^b, Masayuki Endo, MD ^a,^b, Iva Urbankova, MD ^a,^b,^d, Jaromír Vlacil, MD ^a,^b,^d, Thomas Deprest, BMSc ^a, Samantha Bettin, BSc ^a, Bernd Klosterhalfen, MD ^e, Jan Deprest, MD, PhD, FRCOG ^a,^b,^c,^⁎
^a Center for Surgical Technologies, Faculty of Medicine, KU Leuven, Leuven, Belgium
^b Department of Development and Regeneration, Organ Systems Cluster, Faculty of Medicine, KU Leuven, Leuven, Belgium
^c Pelvic Floor Unit, University Hospitals, KU Leuven, Leuven, Belgium
^d Institute for Care of Mother and Child, Prague, Czech Republic
^e Institute for Pathology, Düren, Germany

^∗Corresponding author: Jan Deprest, MD, PhD.

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Abstract

Objective

We aimed to characterize the effect of vaginal or abdominal mesh insertion and of different collagen augmentation of polypropylene mesh in a sheep model. Outcome measures were passive and active biomechanical properties and semiquantitative morphometry.

Study Design

Forty-two Texel sheep were used: 6 were nonimplanted controls (n = 6), the rest were implanted with polypropylene mesh (n = 12; Avaulta Solo; Bard Medical, Covington, GA) or collagen-coated meshes: Avaulta Plus (n = 12; Bard Medical) and Ugytex (n = 12; Sofradim International, Trevoux, France). Through a single incision, the rectovaginal septum was dissected and a 35 × 35–mm mesh was sutured to the underlying tissues. Abdominally, a 50 × 50–mm mesh was laid over a primarily sutured full thickness 40-mm longitudinal incisional defect. Animals were explanted after 60 or 180 days (n = 6 per group). Outcome measures were passive biomechanics by biaxial tensiometry, active contractility of vaginal explants, and histologic evidence.

Results

Vaginal explants were 2.4 times stiffer compared with native vaginal tissue (P < .001), but without differences in comfort zone stiffness or slope of the load-elongation in the physiologic range between the products that were tested. Collagen coating was associated with a 16-fold reduction in contractile force at 180 days, compared with native vaginal tissue, both for Avaulta Plus (P = .032) and Ugytex (P = .015). Abdominal explants were 1.3-times stiffer compared with native abdominal wall tissue (P < .001) and were 1.9-times stiffer compared with vaginal explants.

Conclusion

Vaginal mesh implantation yields less stiff explants compared with abdominal explants. Vaginal mesh implantation also alters the passive and active biomechanical properties compared with native vaginal tissues. Collagen matrices did not reduce the number of graft-related complications.

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Key words : biomechanics, collagen, contractility, mesh, sheep

Plan

Materials and Methods

Histologic information

Polymorphonuclear cells

Collagen-coated polypropylene (Ugytex)

Comparison of biomechanics of vaginal explants with vaginal native tissue

Comment

Vaginal polypropylene mesh insertion

Effect of collagen augmentation

Abdominal vs vaginal environment

Limitations and conclusions

	Supported by the European Commission; a Marie Curie Industria-Academia Partnership Program grant (251356; A.F. and M.E) and the FP7 project BIPUpy (NMP Large–310389; I.U. is a researcher); and a grant for fundamental clinical research from the Fonds Wetenschappelijk Onderzoek Vlaanderen (1801207N; J.D.).
	Our research program is supported by unconditional grants from Johnson & Johnson Medical (Norderstedt, Germany), FEG Textil technik (Aachen, Germany), and Blasingame, Burch, Garrard, and Ashley (Atlanta, GA). Agreements are handled via the Leuven Research and Development transfer office. B.K. is a plaintiff’s expert witness in the mesh litigation Cisson v. Bard and a consultant to FEG Textiltechnik. Sponsors did not interfere with the planning, execution, or reporting of this experiment and do not own the results.
	Cite this article as: Feola A, Endo M, Urbankova I, et al. Host reaction to vaginally inserted collagen containing polypropylene implants in sheep. Am J Obstet Gynecol 2014;212:••••.