The Challenge of Stress Incontinence and Pelvic Organ Prolapse

Revisiting Biologic Mesh Materials

William D'Angelo; Jenna Dziki; Stephen F. Badylak

Disclosures

Curr Opin Urol. 2019;29(4):437-442. 

In This Article

Abstract and Introduction

Abstract

Purpose of review: The present article reviews the history of mesh-related complications and regulations in SUI and POP repair settings, clinical outcomes associated with the use of biologic and synthetic mesh materials, and novel approaches using modified mesh materials.

Recent findings: Treatment of pelvic floor disorders, such as stress urinary incontinence (SUI) and pelvic organ prolapse (POP) commonly involves implantation of synthetic surgical mesh materials like polypropylene. Many synthetic mesh materials, however, are associated with a foreign body response upon implantation, which is characterized by fibrotic encapsulation. Complications, including erosion, infections, bleeding, and chronic pain, have led to warnings by regulatory agencies and the recall of several mesh products. To mitigate such complications, biologic mesh materials have been proposed as alternatives for SUI and POP repair.

Summary: Clinical outcomes of surgical repair of POP/SUI are similar between biologic and synthetic meshes, but biologic meshes have a lower incidence of adverse effects. Several strategies for modifying or functionalizing biological and synthetic meshes have shown promising results in preclinical studies.

Introduction

Stress urinary incontinence (SUI) and pelvic organ prolapse (POP) are common disorders that affect approximately 10–12% of women and often require surgical intervention, and recurrence following surgery affects 30–40% of patients.[1,2] SUI is defined as an involuntary loss of urine that occurs with increased intraabdominal pressure, such as during coughing or sneezing.[3] POP is the descent of the pelvic organs (vagina, uterus, bladder, rectum) into the vagina because of weakening of the pelvic floor muscles and connective tissue,[4] and can cause discomfort and interfere with urination and sexual intercourse. The most common risk factors for POP include pregnancy and childbirth, obesity, and physiologic changes associated with ageing and menopause.[5] POP and SUI that cannot be managed with behavioral interventions including pelvic floor muscle training or the use of a pessary require surgical treatment. Surgical repair methods including both primary repair and/or the use of surgical mesh materials to augment repair have evolved over the past decade, though the optimal repair method remains controversial.[6–8] Although concomitant placement of surgical meshes is, in some cases, effective in decreasing the incidence of recurrence by approximately 65%, there are risks associated with the use of any foreign material, including both synthetic and biologic surgical meshes that must be taken into consideration.[9] Whether or not the use of surgical mesh materials achieves superior outcomes compared with native tissue repair is dependent upon many factors including both surgical technique and the type of mesh. A better understanding of the properties of surgical mesh materials, the extent of which timely integrate with native tissue, and the ability of mesh materials in question to mitigate foreign body reactions is required to improve clinical outcomes.

Complications associated with transvaginal mesh products have prompted the issuance of multiple warnings from the Food and Drug Administration (FDA). There has been both a reclassification of these surgical meshes as high-risk devices, as well as outright bans on their use in the UK, Australia, and New Zealand, prompting the recall of many mesh products from the market.[10–13] The most common complications reported include vaginal erosion, infection, chronic pain, bleeding, difficult or painful urination, and dyspareunia. The incidence of reported adverse events has been as high as 20–40% depending on surgical approach, with the transvaginal approach accounting for the highest percentage of complications.[14–16] Multiple preclinical and clinical studies have shown that meshes composed of synthetic materials, such as polypropylene elicit a foreign body response (FBR), which is characterized by chronic presence of macrophages and multinucleate giant cells immediately adjacent to mesh fibers and dense connective tissue deposition and fibrosis.[17,18] The paradoxical decreased incidence of recurrence combined with the adverse events associated with mesh use has prompted interest in developing strategies to promote improved mesh integration with host tissue. Such strategies include structural/mechanical modifications to more closely mimic native tissue, augmentation or functionalization of synthetic materials with bioactive components to promote a pro-reparative host immune response, and use of decellularized biologic surgical meshes. The present review highlights studies from the last 24 months related to the use of biologic and biomimetic materials as alternatives to traditional synthetic materials for SUI/POP repair.

Comments

3090D553-9492-4563-8681-AD288FA52ACE

processing....