The preliminary study on biomechanical properties of four synthetic implants for reconstructive surgery of pelvic floor dysfunction_Journal of Biomedical Engineering

Authors：

MIAO Yali ¹ , WEN Jirui ² , WANG Shichao ² , ZHAO Zhiwei ² ,  WU Jiang ²

1. West China Second University Hospital, Sichuan University, Key Laboratory of Birth Defects and Related Disease of Women and Children (Sichuan University), Ministry of Education, Chengdu 610041, P.R.China;
2. School of West China Basic Medicine and Forensic Medicine, Sichuan University, Chengdu 610041, P.R.China;

Corresponding author：

WU Jiang, Email: jw@scu.edu.cn

Keywords：

synthetic implants; reconstructive surgery of pelvic floor dysfunction; biomechanics; ultimate stress strength; modulus of elasticity; maximum load; maximum elongation

DOI：

10.7507/1001-5515.201707071

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This study aimed to investigate biomechanical properties of synthetic implants for reconstructive surgery of pelvic floor dysfunction. In this dissertation, we chose four synthetic implants, i.e. total pelvic floor repair system (PROLIFT), gynecone TVT obtutator system (TVT-O), intra-vaginal sling placement device (IVS) and acellular dermal matrix (Renov), for tensile test respectively. The biomechanical properties of four synthetic implants were measured and analyzed using a material testing machine (Instron 4302 versatile material testing machine). The biomechanical parameters included ultimate stress strength, modulus of elasticity, maximum load and maximum elongation. The results showed that the maximum load of the four symthetic implants was TVT-O > IVS > PROLIFT > Renov, and the maximum load of TVT-O was significantly higher than PROLIFT and Renov ( P < 0.05). The ultimate stress strength was TVT-O > IVS > PROLIFT > Renov, with no significant differences among them ( P > 0.05). The maximum elongation of the four implants was TVT-O > PROLIFT > IVS > Renov, and the maximum elongation of TVT-O and PROLIFT were both significantly higher than Renov ( P < 0.05). The modulus of elasticity was IVS > Renov > TVT-O > PROLIFT, with no significant differences among them ( P > 0.05). Taken together, the present study demonstrates that the modulus of elasticity of IVS was the highest in the four synthetic implants; TVT-O had the highest mechanical strength; The maximum load, ultimate stress strength and maximum elongation of Renov were all the lowest; The mechanical properties of PROLIFT was the most stable, and its modulus of elasticity was the lowest in the four synthetic implants, which had good extensibility and elasticity. Therefore, it is necessary to pay attention to the biomechanical properties of new pelvic reconstructive materials for the clinical pelvic reconstructive surgery.

Citation： MIAO Yali, WEN Jirui, WANG Shichao, ZHAO Zhiwei, WU Jiang. The preliminary study on biomechanical properties of four synthetic implants for reconstructive surgery of pelvic floor dysfunction. Journal of Biomedical Engineering, 2018, 35(3): 409-414. doi: 10.7507/1001-5515.201707071 Copy

1.	Morgan J E. A sling operation, using Marlex polypropylene mesh, for treatment of recurrent stress incontinence. Am J Obstet Gynecol, 1970, 106(3): 369-377.
2.	Stanton S L, Brindley G S, Holmes D M. Silastic sling for urethral sphincter incompetence in women. Br J Obstet Gynaecol, 1985, 92(7): 747-750.
3.	Iosif C S. Abdominal sacral colpopexy with use of synthetic mesh. Acta Obstet Gynecol Scand, 1993, 72(3): 214-217.
4.	Cervigni M, Natale F. The use of synthetics in the treatment of pelvic organ prolapse. Curr Opin Urol, 2001, 11(4): 429-435.
5.	Ridgeway B, Chen C C, Paraiso M F. The use of synthetic mesh in pelvic reconstructive surgery. Clin Obstet Gynecol, 2008, 51(1): 136-152.
6.	Gibson L D, Stafford C E. Synthetic mesh repair of abdominal wall defects: follow up and reappraisal. Am Surg, 1964, 30(8): 481-486.
7.	Acquaviva D E, Bourret P. Cure des éventrations par plaques de nylon. Press Med, 1948, 73: 892.
8.	Cosson M, Debodinance P, Boukerrou M, et al. 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 Dysfunct, 2003, 14(3): 169-178.
9.	苗娅莉, 呼春晖, 王建六, 等. 阴道后壁脱垂患者阴道后壁组织生物力学特征初步研究. 中国妇产科临床杂志, 2008, 9(3): 180-183.
10.	Dietz H P, Vancaillie P, Svehla M, et al. Mechanical properties of urogynecologic implant materials. Int Urogynecol J, 2003, 14(4): 239-243.
11.	Goldberg R P, Koduri S, Sand P K, et al. The tensile strength of Cooper's ligament suturing: comparison of abdominal and transvaginal techniques. Int Urogynecol J, 2004, 15(6): 425-427; discussion 428.
12.	Cosson M, Debodinance P, Boukerrou M, et al. 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 Dysfunct, 2003, 14(3): 169-178; discussion 178.
13.	Choe J M, Kothandapani R, James L, et al. Autologous, cadaveric, and synthetic materials used in sling surgery: comparative biomechanical analysis. Urology, 2001, 58(3): 482-486.
14.	Sclafani A P, McCormick S A, Cocker R. Biophysical and microscopic analysis of homologous dermal and fascial materials for facial aesthetic and reconstructive uses. Arch Facial Plast Surg, 2002, 4(3): 164-171.
15.	Clemons J L, Myers D L, Aguilar V C, et al. Vaginal paravaginal repair with an AlloDerm graft. Am J Obstet Gynecol, 2003, 189(6): 1612-1618; discussion 1618-1619.
16.	Hilger W S, Walter A, Zobitz M E, et al. Histological and biomechanical evaluation of implanted graft materials in a rabbit vaginal and abdominal model. Am J Obstet Gynecol, 2006, 195(6): 1826-1831.
17.	Mueller M G, Elborno D, Davé B A, et al. Postoperative appointments: which ones count?. Int Urogynecol J, 2016, 27(12): 1873-1877.
18.	Unger C A, Abbott S, Evans J M, et al. Outcomes following treatment for pelvic floor mesh complications. Int Urogynecol J, 2014, 25(6): 745-749.
19.	Abbott S, Unger C A, Evans J M, et al. Evaluation and management of complications from synthetic mesh after pelvic reconstructive surgery: a multicenter study. Am J Obstet Gynecol, 2014, 210(2): 163.e1-8.
20.	U.S. Food and Drug Administration. FDA safety communication: update on serious complications associated with transvaginal placement of surgical mesh in repair of pelvic organ prolapsed [EB/OL]. (2011-07-13)[2017-07-26]. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm.
21.	U.S. Food and Drug Administration. FDA public health notification: serious complications associated with transvaginal placement of surgical mesh in repair of pelvic organ prolapsed and stress urinary incontinence[EB/OL]. (2012-07-31)[2017-07-26]. http://www.fda.gov/Medical Devices/Safety/AlertsandNotices/PublicHealthNotifications/UCM061976.
22.	Glazener C M, Breeman S, Elders A, et al. Mesh, graft, or standard repair for women having primary transvaginal anterior or posterior compartment prolapse surgery: two parallel-group, multicentre, randomised, controlled trials (PROSPECT). Lancet, 2017, 389(10067): 381-392.

1. Morgan J E. A sling operation, using Marlex polypropylene mesh, for treatment of recurrent stress incontinence. Am J Obstet Gynecol, 1970, 106(3): 369-377.
2. Stanton S L, Brindley G S, Holmes D M. Silastic sling for urethral sphincter incompetence in women. Br J Obstet Gynaecol, 1985, 92(7): 747-750.
3. Iosif C S. Abdominal sacral colpopexy with use of synthetic mesh. Acta Obstet Gynecol Scand, 1993, 72(3): 214-217.
4. Cervigni M, Natale F. The use of synthetics in the treatment of pelvic organ prolapse. Curr Opin Urol, 2001, 11(4): 429-435.
5. Ridgeway B, Chen C C, Paraiso M F. The use of synthetic mesh in pelvic reconstructive surgery. Clin Obstet Gynecol, 2008, 51(1): 136-152.
6. Gibson L D, Stafford C E. Synthetic mesh repair of abdominal wall defects: follow up and reappraisal. Am Surg, 1964, 30(8): 481-486.
7. Acquaviva D E, Bourret P. Cure des éventrations par plaques de nylon. Press Med, 1948, 73: 892.
8. Cosson M, Debodinance P, Boukerrou M, et al. 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 Dysfunct, 2003, 14(3): 169-178.
9. 苗娅莉, 呼春晖, 王建六, 等. 阴道后壁脱垂患者阴道后壁组织生物力学特征初步研究. 中国妇产科临床杂志, 2008, 9(3): 180-183.
10. Dietz H P, Vancaillie P, Svehla M, et al. Mechanical properties of urogynecologic implant materials. Int Urogynecol J, 2003, 14(4): 239-243.
11. Goldberg R P, Koduri S, Sand P K, et al. The tensile strength of Cooper's ligament suturing: comparison of abdominal and transvaginal techniques. Int Urogynecol J, 2004, 15(6): 425-427; discussion 428.
12. Cosson M, Debodinance P, Boukerrou M, et al. 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 Dysfunct, 2003, 14(3): 169-178; discussion 178.
13. Choe J M, Kothandapani R, James L, et al. Autologous, cadaveric, and synthetic materials used in sling surgery: comparative biomechanical analysis. Urology, 2001, 58(3): 482-486.
14. Sclafani A P, McCormick S A, Cocker R. Biophysical and microscopic analysis of homologous dermal and fascial materials for facial aesthetic and reconstructive uses. Arch Facial Plast Surg, 2002, 4(3): 164-171.
15. Clemons J L, Myers D L, Aguilar V C, et al. Vaginal paravaginal repair with an AlloDerm graft. Am J Obstet Gynecol, 2003, 189(6): 1612-1618; discussion 1618-1619.
16. Hilger W S, Walter A, Zobitz M E, et al. Histological and biomechanical evaluation of implanted graft materials in a rabbit vaginal and abdominal model. Am J Obstet Gynecol, 2006, 195(6): 1826-1831.
17. Mueller M G, Elborno D, Davé B A, et al. Postoperative appointments: which ones count?. Int Urogynecol J, 2016, 27(12): 1873-1877.
18. Unger C A, Abbott S, Evans J M, et al. Outcomes following treatment for pelvic floor mesh complications. Int Urogynecol J, 2014, 25(6): 745-749.
19. Abbott S, Unger C A, Evans J M, et al. Evaluation and management of complications from synthetic mesh after pelvic reconstructive surgery: a multicenter study. Am J Obstet Gynecol, 2014, 210(2): 163.e1-8.
20. U.S. Food and Drug Administration. FDA safety communication: update on serious complications associated with transvaginal placement of surgical mesh in repair of pelvic organ prolapsed [EB/OL]. (2011-07-13)[2017-07-26]. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm.
21. U.S. Food and Drug Administration. FDA public health notification: serious complications associated with transvaginal placement of surgical mesh in repair of pelvic organ prolapsed and stress urinary incontinence[EB/OL]. (2012-07-31)[2017-07-26]. http://www.fda.gov/Medical Devices/Safety/AlertsandNotices/PublicHealthNotifications/UCM061976.
22. Glazener C M, Breeman S, Elders A, et al. Mesh, graft, or standard repair for women having primary transvaginal anterior or posterior compartment prolapse surgery: two parallel-group, multicentre, randomised, controlled trials (PROSPECT). Lancet, 2017, 389(10067): 381-392.

Journal of Biomedical Engineering

The preliminary study on biomechanical properties of four synthetic implants for reconstructive surgery of pelvic floor dysfunction

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