Abstract

Stress urinary incontinence (SUI) and pelvic organ prolapse (POP) are conditions which result in significant physical, mental and social consequences for women worldwide. The high rates of recurrence reported with primary repair for POP led to the use of synthetic mesh to augment repairs in both primary and secondary cases following failed previous POP repair. The widely reported, unacceptably high rates of complications associated with the use of synthetic, transvaginal mesh in pelvic floor repair have severely limited the treatment options that surgeons can offer. This article summarises the recent advances in pelvic floor repair, such as improved quantification and modelling of the biomechanics of the pelvic floor and the developing technology within the field of tissue engineering for treatment of SUI/POP, including biomaterials and cell-based therapies. Finally, we will discuss the issues surrounding the commercial introduction of synthetic mesh for use within the pelvic floor and what lessons can be learned for the future as well as the current guidance surrounding treatment for SUI/POP.

Highlights

  • Stress urinary incontinence (SUI) and pelvic organ prolapse (POP) are common conditions affecting women worldwide and are associated with significant morbidity and impact on quality of life

  • This study demonstrated that the meshes that had been seeded with cells had significantly improved biomechanical properties with decreased stiffness and minimal fibrosis

  • The Food and Drug Administration (FDA) 510(k) route for introduction of products to market overestimated the safety of PPL mesh for pelvic floor repair because of their success in treating abdominal wall hernia repair

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Summary

Introduction

Stress urinary incontinence (SUI) and pelvic organ prolapse (POP) are common conditions affecting women worldwide and are associated with significant morbidity and impact on quality of life. There is a renewed focus on locating suitable replacements for PPL mesh to provide mechanical support but avoid the associated complications of pain and tissue erosion This has stimulated researchers to look for alternative materials and there are a range of natural, synthetic, biodegradable or non-biodegradable options from which to choose. The abdominal wall of a rabbit is not a perfect comparison for how biomaterials will behave within the female pelvic floor but this work has allowed the variety of implantable materials to be narrowed down to allow only those with a safe and stable profile to go forward for further testing Another animal model that would more closely mimic the anatomical, physiological and biomechanical properties of the human female pelvic floor was required. All documents stressed the importance of informed consent with detailed explanations of risks to patients prior to the procedure

Discussion
11. Feeley J
32. Hindle C
40. ACell: MatriStem Wound Matrix
65. Food and Drug Administration
70. European Commission
Findings
72. Scottish Government
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