Synthetic Materials Used in the Surgical Treatment of Pelvic Organ Prolapse: Problems of Currently Used Material and Designing the Ideal Material

Abstract

Synthetic materials have long been used to provide structural support when surgically repairing pelvic organ prolapse (POP). The most widely used synthetic material is a mesh made of polypropylene (PPL). The use of mesh is intended to improve cure rates and prevent recurrences after POP surgery -however as more mesh materials have been implanted, it has become apparent that serious complications can occur in up to 30% of women, particularly when the mesh is implanted transvaginally. Over the years many different mesh kits have been marketed and used in the treatment of POP however polypropylene mesh was never designed or tested for use in pelvic floor. Instead it was approved for clinical use based on its biocompatibility and success in abdominal hernia repairs. It is now known that PPL meshes are neither compliant with the mechanical forces in the pelvic floor nor do they integrate well into paravaginal tissues. Better materials developed specifically for use in pelvic floor are urgently needed. The aim of this chapter is to define the requirements of an ideal mesh in terms of its material properties and to summarize the ongoing research on developing the next generation pelvic floor repair materials.

3D Printing of Drug-Loaded Thermoplastic Polyurethane Meshes: A Potential Material for Soft Tissue Reinforcement in Vaginal Surgery

“…Pelvic organ prolapse (POP) and stress urinary incontinence (SUI), are two very common disorders affecting 30-40% of women worldwide, mainly with the increase in age [1]. Since the population is growing gradually older, with the passage of time there will be an increase in the incidence of POP of 46% between 2010 and 2050 [2]. Although they are not lethal diseases, these two pathologies negatively influence the quality of life of women, including their social, sexual, physical and psychological well-being [1,3].…”

Novel VEGFR‐2 inhibitors with an N‐acylhydrazone scaffold

“…Then, the CAMs were collected and color images were obtained using a stereomicroscope (Zeiss STEMI 305). The angiogenesis quantification was performed according to Mangir et al [75] Briefly, the color images were converted into black and white using Adobe Photoshop CS6. The magenta, blue, cyan, and green colors were reduced to −200% and yellow color to 0%;…”

Urogynecological surgical mesh implants: New trends in materials, manufacturing and therapeutic approaches

“…The implantation of PP mesh for POP and SUI repair was an acceptable practice prior to the FDA releasing two public health warnings in 2008 and 2011, which were followed by the release of statements from the UK Medicines and Healthcare products Regulatory Agency (MHRA). These warnings were the result of widespread reports regarding complications associated with the transvaginal implantation of PP mesh in the PF (Mangir et al, 2018). Women worldwide were, and currently still are, experiencing adverse effects such as chronic pain, mesh-related infection, inflammatory reactions and mesh erosion.…”

“…Many patients have begun to seek compensation, and although the exact quantification of litigation costs in the US is difficult to determine, the global pharmaceutical company Endo International Plc has reserved $2.6b to deal with mesh lawsuits (Mironska et al, 2019). In the UK, approximately 800 compensation claims have arose against the NHS regarding mesh-related complications (Mangir et al, 2018). The NHS England put an immediate stop to mesh procedures in accordance with NICE guidelines, which strongly recommend that transvaginal mesh should not be used for POP repair, indicating the need for alternative treatment options to improve PFDs repair (BBC News, 2018a;Wise, 2017).…”

“…Transvaginal mesh products were reclassified from moderate-risk class II devices to high-risk class III devices in 2016, meaning the 510(k) process can no longer be used for mesh products to gain market access. A sharp decline from 27% to 2% has been observed in the use of transvaginal mesh for POP repair surgery, and the number of SUI surgeries using mesh sling has decreased as a knock-on effect (Mangir et al, 2018). Exactly 20 years after the first notification, on April 16, 2019, once confirming the high level of risks with respect to the benefits, the FDA ordered a stop to the production and sale of surgical meshes intended for transvaginal repair of anterior prolapse (cystocele) (U.S. Food and Drug Administration, n.d.).…”