Mechanical biocompatibility of prosthetic meshes: A comprehensive protocol for mechanical characterization

Journal of the Mechanical Behavior of Biomedical Materials

Volumn 40, Issue , 2014, Pages 42-58

  Maurer, M M ^a   Rohrnbauer B ^a   Feola, A ^b   Deprest, J ^b   Mazza, E ^a,c  

^a Institute of Mechanical Systems (IMES)   (Switzerland)

^b Center for Surgical Technologies Leuven   (Belgium)

^c SWISS FEDERAL LABORATORIES FOR MATERIALS SCIENCE AND TECHNOLOGY   (Switzerland)

Author keywords

Anisotropy; Cyclic behavior; Mechanical biocompatibility; Mechanical testing; Mesh prostheses; Multiaxial stiffness

Indexed keywords

ANISOTROPY; BIOCOMPATIBILITY; DEFORMATION; MECHANICAL TESTING; MESH GENERATION; PROSTHETICS; STIFFNESS; STIFFNESS MATRIX;

COMPREHENSIVE PROTOCOLS; CYCLIC BEHAVIOR; EXPERIMENTAL PROTOCOLS; MECHANICAL BIOCOMPATIBILITY; MECHANICAL CHARACTERIZATIONS; MULTIAXIAL; QUANTITATIVE ASSESSMENTS; UNIAXIAL AND BIAXIAL LOADINGS;

MECHANISMS;

ARTICLE; BIOCOMPATIBILITY; MEASUREMENT; MECHANICS; PARAMETERS; PROSTHETIC MESH; STRESS STRAIN RELATIONSHIP; SURGICAL MESH; DEVICES; MATERIALS TESTING; PROCEDURES; PROSTHESES AND ORTHOSES; WEIGHT BEARING;

ELASTOMER;

ELASTOMERS; MATERIALS TESTING; MECHANICAL PROCESSES; PROSTHESES AND IMPLANTS; WEIGHT-BEARING;

EID: 84907618572     PISSN: 17516161     EISSN: 18780180     Source Type: Journal    
DOI: 10.1016/j.jmbbm.2014.08.005     Document Type: Article

References (54)

1. Afonso J.S., Martins P.a.L.S., Girao M.J.B.C., Natal Jorge R.M., Ferreira a.J.M., Mascarenhas T., Fernandes a.a., Bernardes J., Baracat E.C., Rodrigues de Lima G., Patricio B. Mechanical properties of polypropylene mesh used in pelvic floor repair. Int. Urogynecol. J. Pelvic Floor Dysfunct. 2008, 19:375-380.
2. Arnold G.A., Mathews K.G., Roe S., Mente P., Seaboch T. Biomechanical comparison of four soft tissue replacement materials: an in vitro evaluation of single and multilaminate porcine small intestinal submucosa, canine fascia lata, and polypropylene mesh. Vet. Surg.: VS 2009, 38:834-844.
3. Boukerrou M., Boulanger L., Rubod C., Lambaudie E., Dubois P., Cosson M. Study of the biomechanical properties of synthetic mesh implanted in vivo. Eur. J. Obstet. Gynaecol. Reprod. Biol. 2007, 134:262-267.
4. Choe J.M., Kothandapani R., James L., Bowling D. Autologous, cadaveric, and synthetic materials used in sling surgery: comparative biomechanical analysis. Urology 2001, 58:482-486.
5. Chu C.C., Welch L. Characterization of morphologic and mechanical properties of surgical mesh fabrics. J. Biomed. Mater. Res. 1985, 19:903-916.
6. Cobb W.S., Kercher K.W., Heniford B.T. The argument for lightweight polypropylene mesh in hernia repair. Surg. Innov. 2005, 12:63-69.
7. Coda A., Lamberti R., Martorana S. Classification of prosthetics used in hernia repair based on weight and biomaterial. Hernia: The Journal of Hernias and Abdominal Wall Surgery 2012, 16:9-20.
8. Cosson M., Debodinance P., Boukerrou M., Chauvet M.P., Lobry P., Crépin G., Ego A. Mechanical properties of synthetic implants used in the repair of prolapse and urinary incontinence in women: which is the ideal material?. Int. Urogynecol. J. Pelvic Floor Dysfunc. 2003, 14:169-178. (discussion 178).
9. Deprest J., Zheng F., Konstantinovic M., Spelzini F., Claerhout F., Steensma A., Ozog Y., De Ridder D. The biology behind fascial defects and the use of implants in pelvic organ prolapse repair. Int. Urogynecol. J. Pelvic Floor Dysfunct. 2006, 17(Suppl 1):S16-S25.
10. Dietz H.P., Vancaillie P., Svehla M., Walsh W., Steensma a.B., Vancaillie T.G. Mechanical properties of urogynecologic implant materials. Int. Urogynecol. J. Pelvic Floor Dysfunct. 2003, 14:239-243. (discussion 243).
11. Edwards S.L., Werkmeister J.A., Rosamilia A., Ramshaw J.A.M., White J.F., E G.C. Characterisation of clinical and newly fabricated meshes for pelvic organ prolapse repair. J. Mech. Behav. Biomed. Mater. 2013, 23:53-61.
12. Endo M., Feola A., Sindhwani N., Manodoro S., Vlacil J., Engels A.C., Claus F., Deprest J. Mesh contraction: in vivo documentation of changes in apparent surface area utilizing meshes visible on magnetic resonance imaging in the rabbit abdominal wall model. Int. Urogynecol. J. Online First 2014.
13. FDA, 2012. FDA Centre for Devices and Radiological Health: FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse http://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm262435.htm.
14. Fenner D.E. New surgical mesh. Clin. Obstet. Gynecol. 2000, 43:650-658.
15. Feola A., Abramowitch S., Jallah Z., Stein S., Barone W., Palcsey S., Moalli P. Deterioration in biomechanical properties of the vagina following implantation of a high-stiffness prolapse mesh. BJOG: An International Journal of Obstetrics and Gynaecology 2013, 120:224-232.
16. Feola A., Barone W., Moalli P., Abramowitch S. Characterizing the ex vivo textile and structural properties of synthetic prolapse mesh products. Int. Urogynecol. J. 2013, 24:559-564.
17. Fung Y.C. Biomechanics: Mechanical Properties of Living Tissues 1993, Springer-Verlag, New York.
18. Gabriel B., Rubod C., Brieu M., Dedet B., de Landsheere L., Delmas V., Cosson M. Vagina, abdominal skin, and aponeurosis: do they have similar biomechanical properties?. Int. Urogynecol. J. 2011, 22:23-27.
19. Helström L., Nilsson B. Impact of vaginal surgery on sexuality and quality of life in women with urinary incontinence or genital descensus. Acta Obstet. Gynecol. Scand. 2005, 84:79-84.
20. Hilger W.S., Walter A., Zobitz M.E., Leslie K.O., Magtibay P., Cornella J. Histological and biomechanical evaluation of implanted graft materials in a rabbit vaginal and abdominal model. Am. J. Obstet. Gynecol. 2006, 195:1826-1831.
21. Hollenstein M., Ehret A.E., Itskov M., Mazza E. A novel experimental procedure based on pure shear testing of dermatome-cut samples applied to porcine skin. Biomech. Model. Mechanobiol. 2011, 10:651-661.
22. Jing D., Lien K.-C., Ashton-Miller J., DeLancey J.O.L. Visco-hyperelastic properties of the pelvic floor muscles in healthy women. NACOB 2008, 1-2.
23. Jones K.a., Feola A., Meyn L., Abramowitch S.D., Moalli P.a. Tensile properties of commonly used prolapse meshes. International urogynecology. J. Pelvic Floor Dysfunc. 2009, 20:847-853.
24. Junge K., Klinge U., Prescher A., Giboni P., Niewiera M., Schumpelick V. Elasticity of the anterior abdominal wall and impact for reparation of incisional hernias using mesh implants. Hernia 2001, 5:113-118.
25. Klinge U., Klosterhalfen B. Modified classification of surgical meshes for hernia repair based on the analyses of 1000 explanted meshes. Hernia: The Journal of Hernias and Abdominal Wall Surgery 2012, 16:251-258.
26. Klinge U., Klosterhalfen B., Birkenhauer V., Junge K., Conze J., Schumpelick V. Impact of polymer pore size on the interface scar formation in a rat model. J. Surg. Res. 2002, 103:208-214.
27. Klinge U., Klosterhalfen B., Müller M., Ottinger a.P., Schumpelick V. Shrinking of polypropylene mesh in vivo: an experimental study in dogs. Eur. J. Surg. Acta Chir. 1998, 164:965-969.
28. Klosterhalfen B., Junge K., Klinge U. The lightweight and large porous mesh concept for hernia repair. Exp. Rev. Med. Devices 2005, 2:103-117.
29. Konerding M.a., Chantereau P., Delventhal V., Holste J.-L., Ackermann M. Biomechanical and histological evaluation of abdominal wall compliance with intraperitoneal onlay mesh implants in rabbits: a comparison of six different state-of-the-art meshes. Med. Eng. Phys. 2012, 34:806-816.
30. Konstantinovic M., Ozog Y., Spelzini F., Pottier C., de Ridder D., Deprest J. Biomechanical findings in rats undergoing fascial reconstruction with graft materials suggested as an alternative to polypropylene. Neurourol. Urodyn. 2010, 29:488-493.
31. Konstantinovic M.L., Pille E., Malinowska M., Verbeken E., De Ridder D., Deprest J. Tensile strength and host response towards different polypropylene implant materials used for augmentation of fascial repair in a rat model. Int. Urogynecol. J. Pelvic Floor Dysfunct. 2007, 18:619-626.
32. Krause H., Bennett M., Forwood M., Goh J. Biomechanical properties of raw meshes used in pelvic floor reconstruction. Int. Urogynecol. J. Pelvic Floor Dysfunct. 2008, 19:1677-1681.
33. Liang R., Abramowitch S., Knight K., Palcsey S., Nolfi a., Feola a., Stein S., Moalli P.A. Vaginal degeneration following implantation of synthetic mesh with increased stiffness. BJOG: An International Journal of Obstetrics and Gynaecology 2013, 120:233-243.
34. Lowman J.K., Jones L.a., Woodman P.J., Hale D.S. Does the Prolift system cause dyspareunia?. Am. J. Obstet. Gynecol. 2008, 199. (707.e701-706).
35. Mangera A., Bullock A.J., Chapple C.R., Macneil S. Are biomechanical properties predictive of the success of prostheses used in stress urinary incontinence and pelvic organ prolapse? A systematic review. Neurourol. Urodyn. 2012, 31:13-21.
36. Manodoro S., Endo M., Uvin P., Albersen M., Vlácil J., Engels A., Schmidt B., de Ridder D., Feola A., Deprest J. Graft-related complications and biaxial tensiometry following experimental vaginal implantation of flat mesh of variable dimensions. Br. J. Obstet. Gynaecol. 2013, 120:244-250.
37. Moalli P.a., Papas N., Menefee S., Albo M., Meyn L., Abramowitch S.D. Tensile properties of five commonly used mid-urethral slings relative to the TVT. Int. Urogynecol. J. Pelvic Floor Dysfunct. 2008, 19:655-663.
38. Mühl T., Binnebösel M., Klinge U., Goedderz T. New objective measurement to characterize the porosity of textile implants. J. Biomed. Mater. Res. B Appl. Biomater. 2008, 84:176-183.
39. Ozog Y., Konstantinovic M., Werbrouck E., De Ridder D., Mazza E., Deprest J. Persistence of polypropylene mesh anisotropy after implantation: an experimental study. BJOG: An International Journal of Obstetrics and Gynaecology 2011, 118:1180-1185.
40. Ozog Y., Konstantinovic M.L., Werbrouck E., De Ridder D., Edoardo M., Deprest J. Shrinkage and biomechanical evaluation of lightweight synthetics in a rabbit model for primary fascial repair. Int. Urogynecol. J. 2011, 22:1099-1108.
41. Ozog Y., Mazza E., de Ridder D., Deprest J. Biomechanical effects of polyglecaprone fibers in a polypropylene mesh after abdominal and rectovaginal implantation in a rabbit. Int. Urogynecol. J. 2012, 23.
42. Peña E., Calvo B., Martínez M.a., Martins P., Mascarenhas T., Jorge R.M.N., Ferreira a., Doblaré M. Experimental study and constitutive modeling of the viscoelastic mechanical properties of the human prolapsed vaginal tissue. Biomech. Model. Mechanobiol. 2010, 9:35-44.
43. Pierce L.M., Rao A., Baumann S.S., Glassberg J.E., Kuehl T.J., Muir T.W. Long-term histologic response to synthetic and biologic graft materials implanted in the vagina and abdomen of a rabbit model. Am. J. Obstet. Gynecol. 2009, 200. (546.e541-548).
44. Pourdeyhimi B. Porosity of surgical mesh fabrics: new technology. J. Biomed. Mater. Res. 1989, 23:145-152.
45. Röhrnbauer, B., 2013. Mechanical Characterization and Modeling of Prosthetic Meshes.
46. Röhrnbauer B., Mazza E. A non-biological model system to simulate the in vivo mechanical behavior of prosthetic meshes. J. Mech. Behav. Biomed. Mater. 2013, 20:305-315.
47. Röhrnbauer B., Mazza E. Uniaxial and biaxial mechanical characterization of a prosthetic mesh at different length scales. J. Mech. Behav. Biomed. Mater. 2014, 29:7-19.
48. Rubod C., Boukerrou M., Brieu M., Jean-Charles C., Dubois P., Cosson M. Biomechanical properties of vaginal tissue: preliminary results. Int. Urogynecol. J. Pelvic Floor Dysfunct. 2008, 19:811-816.
49. Saberski E.R., Orenstein S.B., Novitsky Y.W. Anisotropic evaluation of synthetic surgical meshes. Hernia: The Journal of Hernias and Abdominal Wall Surgery 2011, 15:47-52.
50. Shepherd J.P., Feola A.J., Abramowitch S.D., Moalli P.a. Uniaxial biomechanical properties of seven different vaginally implanted meshes for pelvic organ prolapse. Int. Urogynecol. J. 2012, 23:613-620.
51. Slack M., Ostergard D., Cervigni M., Deprest J. A standardized description of graft-containing meshes and recommended steps before the introduction of medical devices for prolapse surgery. Consensus of the 2nd IUGA Grafts Roundtable: optimizing safety and appropriateness of graft use in transvaginal pelvic reconstructive surgery. Int. Urogynecol. J. 2012, 23(Suppl 1):S15-S26.
52. Slack M., Sandhu J.S., Staskin D.R., Grant R.C. In vivo comparison of suburethral sling materials. Int. Urogynecol. J. Pelvic Floor Dysfunct. 2006, 17:106-110.
53. Spiess P.E., Rabah D., Herrera C., Singh G., Moore R., Corcos J. The tensile properties of tension-free vaginal tape and cadaveric fascia lata in an in vivo rat model. BJU Int. 2004, 93:171-173.
54. Ulrich D., Edwards S.L., White J.F., Supit T., Ramshaw J.A.M., Lo C., Rosamilia A., Werkmeister J.A., Gargett C.E. A preclinical evaluation of alternative synthetic biomaterials for fascial defect repair using a rat abdominal hernia model. PLoS One 2012, 7:1-12.