Assessment of Electrospun and Ultra-lightweight Polypropylene Meshes in the Sheep Model for Vaginal Surgery

Hympánová, Lucie; Rynkevic, Rita; Román, Sabiniano; Cunha, Marina Gabriela Monteiro Carvalho Mori da; Mazza, Edoardo; Zündel, Manuel; Urbánková, Iva; Gallego, Monica Ramos; Vange, Jakob; Callewaert, Geertje; Chapple, Christopher R.; MacNeil, Sheila; Deprest, Jan

doi:10.1016/j.euf.2018.07.024

Cited by 43 publications

(58 citation statements)

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“…Sheep have been frequently used in vaginal surgery training that is, vaginal hysterectomy or transvaginal meshes insertion [56,57]. The second approach was used also in reproductive medicine research to test novel implant materials that is, collagen coated or electrospun meshes [13,15,58,59]. Other methodologic strengths are that we used ball-burst testing which more closely represents the in vivo-biomechanical situation as compared to uniaxial testing, often used in the literature.…”

Section: Discussionmentioning

confidence: 99%

Morphological and Functional Changes in the Vagina following Critical Lifespan Events in the Ewe

Hympánová

Rynkevic

Urbánková

et al. 2019

Gynecol Obstet Invest

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Background/Aims: The ewe is increasingly being used as an animal model for pelvic floor disorders. The aim was to further characterize changes in the vaginal properties during its entire lifespan. Methods: Vaginal tissues were collected at different stages of reproductive life (neonatal, prepubescence, nulliparous, primiparous, multiparous, and menopausal; ≥6 ewes/group). Vaginal size, as well as active and passive biomechanics, was measured. Microscopy included thickness of glycogen, epithelium, lamina propria and muscularis thickness, densities of collagen, elastin, smooth muscle, and nerves. Results: Vaginal dimensions increase during adolescence, peak at reproductive levels, and decrease sharply after ovariectomy. One year after first delivery, the distal vagina gets more compliant, yet this is reversed later in life. The thickness of glycogen staining epithelial layers changed with puberty and menopause. The epithelium was markedly thicker after multiple deliveries. The thickness of lamina propria and muscularis increased in puberty and in nulliparous. Semi-quantitative collagen assessment demonstrated a lower collagen and higher elastin content after first and multiple deliveries. Conclusion: The changes in the ovine vaginal wall during representative moments of her lifespan parallel those observed in women.

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Section: Discussionmentioning

confidence: 99%

Morphological and Functional Changes in the Vagina following Critical Lifespan Events in the Ewe

Hympánová

Rynkevic

Urbánková

et al. 2019

Gynecol Obstet Invest

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“…However, complications such as adhesion to the viscera and high inflammatory response found in the repair of the pelvic floor [8] have led researchers to study alternative solutions. Biodegradable/bioresorbable polymers, such as poly(caprolactone) or poly(lactic acid) (PLA), have been used for mesh implant application with mixed results [9][10][11]. In some cases, this type of implants can display mechanical failures due to their degradation.…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2020

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Current strategies to treat pelvic organ prolapse (POP) or stress urinary incontinence (SUI), include the surgical implantation of vaginal meshes. Recently, there have been multiple reports of issues generated by these meshes conventionally made of poly(propylene). This material is not the ideal candidate, due to its mechanical properties leading to complications such as chronic pain and infection. In the present manuscript, we propose the use of an alternative material, thermoplastic polyurethane (TPU), loaded with an antibiotic in combination with fused deposition modelling (FDM) to prepare safer vaginal meshes. For this purpose, TPU filaments containing levofloxacin (LFX) in various concentrations (e.g., 0.25%, 0.5%, and 1%) were produced by extrusion. These filaments were used to 3D print vaginal meshes. The printed meshes were fully characterized through different tests/analyses such as fracture force studies, attenuated total reflection-Fourier transform infrared, thermal analysis, scanning electron microscopy, X-ray microcomputed tomography (μCT), release studies and microbiology testing. The results showed that LFX was uniformly distributed within the TPU matrix, regardless the concentration loaded. The mechanical properties showed that poly(propylene) (PP) is a tougher material with a lower elasticity than TPU, which seemed to be a more suitable material due to its elasticity. In addition, the printed meshes showed a significant bacteriostatic activity on both Staphylococcus aureus and Escherichia coli cultures, minimising the risk of infection after implanting them. Therefore, the incorporation of LFX to the TPU matrix can be used to prepare anti-infective vaginal meshes with enhanced mechanical properties compared with current PP vaginal meshes.

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“…Another promising material is polyurethane which has increased elasticity that can withstand cyclic mechanical distension in vitro 142 . Electrospun polyurethanes and electrospun ureidopyrimidinone-polycarbonate scaffolds, led to a better host response with an M2 type predominant (remodelling response) inflammatory response than ultralightweight PPL meshes after implantation into sheep vagina for 6 months 143 . Electrospun materials and ultralightweight PPL were similar with regards to graft-related complications, passive mechanical properties and their effects on vaginal contractility 143 .…”

Section: [H1] Designing Improved Materialsmentioning

confidence: 99%

“…Electrospun polyurethanes and electrospun ureidopyrimidinone-polycarbonate scaffolds, led to a better host response with an M2 type predominant (remodelling response) inflammatory response than ultralightweight PPL meshes after implantation into sheep vagina for 6 months 143 . Electrospun materials and ultralightweight PPL were similar with regards to graft-related complications, passive mechanical properties and their effects on vaginal contractility 143 . These suggest that materials with increased elasticity can be promising candidate materials for use in pelvic floor reconstruction.…”

Section: [H1] Designing Improved Materialsmentioning

confidence: 99%

Landmarks in vaginal mesh development: polypropylene mesh for treatment of SUI and POP

et al. 2019

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Vaginal meshes used in the treatment of stress urinary incontinence (SUI) and pelvic organ prolapse (POP) have produced highly variable outcomes causing life-changing complications in some patients while providing others with effective, minimally invasive treatments. The issue surrounding the risk:benefit ratio when using the vaginal meshes is complex in which a combination of several factors, including the inherent incompatibility of the mesh material with some applications in pelvic reconstructive surgeries and the lack of appropriate regulatory approval processes at the time of premarket clearance of these products , have contributed to occurrence of complications caused by vaginal mesh. Surgical mesh used in hernia repair has evolved over many years from metal implants to knitted polymer meshes that were adopted for use in the pelvic floor for treatment of POP and SUI. The evolution of the material and textile properties of the surgical mesh was guided by clinical feedback from hernia repair procedures, which were also being modified to obtain the best outcomes with use of the mesh. Current evidence shows how surgical mesh fails biomechanically when used in pelvic floor and materials with improved performance can be developed using modern material processing and tissue engineering techniques. [H1] IntroductionVaginal meshes that are currently used in the surgical treatment of stress urinary incontinence (SUI) and pelvic organ prolapse (POP) can result in life-changing complications in some women who have vaginal mesh implants 1 . These adverse outcomes are now considered a major public health problem; New Zealand becoming the first country in the world to ban the use of transvaginal POP mesh products while still allowing transvaginal SUI meshes (except minislings) in December 2017 2 . In the UK, two public enquiries performed by the Scottish (in 2015) 3 and English (in 2017) 4 governments, in part, as a result of pressure from patient groups led to suspension of vaginal mesh products, both for SUI and POP, from July 2018 onwards 5 . The newest guidance by the National Institute of Health and Care Excellence (NICE) in the UK recommends that retropubic sling materials can be offered to women with SUI if nonsurgical management has failed 6 . In response, the British Society of Urogynaecologists expressed strong disagreement with the decision to suspend the use of vaginal mesh for SUI, but not POP, stating that this decision would deprive many women of an effective and safe treatment option as demonstrated by level I evidence 7 8 . Mesh manufacturers are currently facing lawsuits in the USA and Europe 9 . The issue with mesh repairs for SUI and POP is complex, as the vaginal mesh is implanted in the female pelvic floor in several different ways with very different outcomes in efficacy and complication outcomes. When used as a tape to treat SUI, many patients are effectively cured with the benefits outweighing the risks 10,11 , whereas when used for transvaginal POP repair, complications are more frequent 12 with...

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Assessment of Electrospun and Ultra-lightweight Polypropylene Meshes in the Sheep Model for Vaginal Surgery

Abstract: Product innovation is needed to reduce implant-related complications. We tested two novel implants, electrospun and an ultra-lightweight polypropylene textile mesh, in a physiologically relevant model for vaginal surgery. All gave encouraging outcomes.

Cited by 43 publications

References 29 publications

Morphological and Functional Changes in the Vagina following Critical Lifespan Events in the Ewe

Morphological and Functional Changes in the Vagina following Critical Lifespan Events in the Ewe

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

Landmarks in vaginal mesh development: polypropylene mesh for treatment of SUI and POP

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