Stress Urinary Incontinence and Pelvic Organ Prolapse: Biologic Graft Materials Revisited - Beyond the Abstract

Stress urinary incontinence (SUI) affects an estimated 20-40% of females while a female’s estimated lifetime risk of pelvic organ prolapse (POP) is 30-50%, with 2.9% of females becoming symptomatic. Although SUI and POP are not life-threatening illnesses, they can negatively impact on women’s quality of life and confer a substantial health care burden on the aging population.

Symptomatic SUI and POP refractory to conservative management may require surgical intervention with different forms of biologic or synthetic material. Surgical interventions for SUI have advanced from the first described use of a gracilis muscle flap in 1907 to the Aldridge fascial sling in 1942, Burch colposuspension in 1961 and the previous gold standard McGuire rectus fascia sling described in 1978. The modern synthetic mesh sling was first introduced in 1995 and refined as the tension-free vaginal tape (TVT) by Ulmsten.

However, complications associated with the use of synthetic meshes in SUI and POP repair began to emerge in the ensuing years prompting The Food and Drug Administration (FDA) to issue a public health notification in 2008 regarding ‘serious complications associated with transvaginal placement of surgical mesh in repair of pelvic organ prolapse.’ The most commonly reported complications include; pain, infection, urinary dysfunction or incontinence, vaginal epithelium erosions and recurrence of prolapse. A further warning for complications was issued in 2011, and in 2016 transvaginal mesh for POP was classified as a high-risk class 3 device by the FDA. This was followed by an outright ban on their use in the UK, Australia and New Zealand in 2018. Following a review in April 2019, the FDA ordered manufacturers to stop selling transvaginal polypropylene mesh for POP repair.

Due to biocompatibility and lower rates of infection/inflammatory reaction, biologic grafts have arisen as possible alternatives to synthetic materials for SUI and POP repair. Recent advancements have focused on the use of decellularised biological surgical grafts, augmentation of synthetic materials with bioactive components, and mechanical/structural engineering of biologic grafts for closer imitation of native tissue. While our findings demonstrate that newly developed biologic grafts have a lower incidence of adverse events when compared with synthetic biomaterials, there remains a disparity between success in preclinical trials and their translation into significant clinical results. Further investigation and characterization of biological materials, structural and mechanical engineering of biological grafts and augmentation of synthetic meshes with bioactive components are required to optimize patient outcomes.

Written by: Jack Whooley, Eoghan M Cunnane, Ronaldo Do Amaral, Michael Joyce, Eoin MacCraith, Hugh D Flood, Fergal J O'Brien, Niall F Davis

Beaumont Hospital, Department of Urology and Transplantation Surgery, Beaumont Road, Beaumont, Dublin 9, Dublin, Leinster, Ireland; ., Tissue Engineering Research Group, Department of Anatomy and Regenerative Medicine, Royal College of Surgeons in Ireland, Dublin, Ireland; Trinity Centre for Biomedical Engineering, Trinity College Dublin, Dublin, Ireland; Advanced Materials and Bioengineering Research Centre (AMBER), RCSI and TCD, Dublin, Ireland, Dublin , Ireland; ., Tissue Engineering Research Group, Department of Anatomy and Regenerative Medicine, Royal College of Surgeons in Ireland, Dublin, Ireland; Trinity Centre for Biomedical Engineering, Trinity College Dublin, Dublin, Ireland; Advanced Materials and Bioengineering Research Centre (AMBER), RCSI and TCD, Dublin, Ireland, Dublin, Ireland; ., Tissue Engineering Research Group, Department of Anatomy and Regenerative Medicine, Royal College of Surgeons in Ireland, Dublin, Ireland; Trinity Centre for Biomedical Engineering, Trinity College Dublin, Dublin, Ireland; Advanced Materials and Bioengineering Research Centre (AMBER), RCSI and TCD, Dublin, Ireland, Dublin , Ireland; ., Beaumont Hospital, Department of Urology and Transplantation Surgery, Dublin, Leinster, Ireland; ., Tissue Engineering Research Group, Department of Anatomy and Regenerative Medicine, Royal College of Surgeons in Ireland, Dublin, Ireland; Trinity Centre for Biomedical Engineering, Trinity College Dublin, Dublin, Ireland; Advanced Materials and Bioengineering Research Centre (AMBER), RCSI and TCD, Dublin, Ireland, Dublin, Ireland; ., Tissue Engineering Research Group, Department of Anatomy and Regenerative Medicine, Royal College of Surgeons in Ireland, Dublin, Ireland; Trinity Centre for Biomedical Engineering, Trinity College Dublin, Dublin, Ireland; Advanced Materials and Bioengineering Research Centre (AMBER), RCSI and TCD, Dublin, Ireland, Dublin , Ireland; ., Beaumont Hospital, Department of Urology and Transplantation Surgery, Dublin, Leinster, Ireland.

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