Features of In Vitro Degradation and Physical Properties of a Biopolymer and In Vivo Tissue Reactions in Comparison with Polypropylene

Бондарев, Олег Иванович; Мозес, Вадим Гельевич; Лапий, Г. А.; Лушникова, Е. Л.

doi:10.1007/s10517-020-05010-5

Cited by 3 publications

(3 citation statements)

References 7 publications

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“…Not placed under tension, which may affect results USA Bickhaus et al [ 8 ] Mesh B: lightweight, knitted PP mesh 1.5-mm pores Rat (SD) Lightweight PP meshes with 1.5-mm pore size Vagina and proximal vs distal lumbar vertebrae Comparison between sham operation only (control), mesh sutured only on the vagina (vaginal mesh), sacrocolpopexy without tension, and sacrocolpopexy with tension 90 Attachment of prolapse mesh resulted in an increased histological inflammatory response independent of tension Ovariectomy to cancel hormonal effects on outcomes USA Bickhaus et al [ 9 ] Rat (Wistar) Mesh A: biodegradable polymer 65% polycaprolactone and 35% polytrimethylene carbonate Inter-fascial space between dorsal muscles (back) Each rat had two meshes placed at the back, experimental and PP mesh, each 1 × 1 cm 90 and 180 Mesh A degraded by 9% over 6 months, noted to be too fast to allow tissue regeneration. More fibrosis noted with biopolymer matrix, which is ideal for managing POP Biodegradable polymer not suitable for long-term prolapse support Russia Eisenakh et al [ 10 ] Mesh B: PP mesh Rat (SD) Gynemesh® Vagina Ovariectomy performed 1 week prior to mesh implantation. PP mesh seeded with human umbilical cord-derived stem cells 7, 28 and 84 At 12 weeks, better outcomes with stem cells seeded PP mesh with host response and tissue regeneration Testing stem cells coating on larger animals would provide more accurate results China Deng et al [ 11 ] Rat (SD) Mesh A: novel polycarbonate material based on fourfold hydrogen bonding ureidopyrimidinone Abdominal wall Abdominal wall was reconstructed with mesh in the rat hernia model 2, 7, 14, 28 and 90 Results showed th...…”

Section: Resultsmentioning

confidence: 99%

“…However, this prevents investigation of efficacy. The small size of rats also imposes limitations on the level of tension that can be applied when investigating pelvic mesh, thereby restricting the scope of investigations [ 10 ]. Although the rat model cannot be used to test treatment efficacy, it is readily available for toxicology and biocompatibility.…”

Section: Resultsmentioning

confidence: 99%

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The use of animal models in preclinical investigations for the development of a surgical mesh for pelvic organ prolapse

Seifalian,

Digesu,

Khullar

2024

Int Urogynecol J

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Introduction and hypothesis Polypropylene (PP) mesh for the treatment of pelvic organ prolapse (POP) has raised substantial concerns over long-term complications, leading to its ban in multiple countries. In response, emerging materials are being explored as alternatives for prolapse surgery. Preclinical animal models have historically played a pivotal role in validating medical devices, prior to clinical trials. Successful translation of these materials necessitates the identification of suitable animal models that replicate the female human pelvis and its biomechanical properties. Preclinical in vivo testing assesses the safety of surgical mesh and treatment efficacy in preventing POP recurrence. Methods The research critically reviews animal models used for preclinical pelvic mesh testing over the last decade and proposes a promising model for future preclinical studies. Results Rats were the most common mammal used for toxicity and biocompatibility investigations through abdominal implantation. Although non-human primates serve as a gold standard for efficacy testing, ethical considerations limit their use owing to their close biological and cognitive resemblance to humans. Consequently, sheep were the most preferred large animal model owing to their reproductive system similarities and propensity for spontaneous POP following parity. Conclusion The study contributes valuable insights into the selection of appropriate animal models for preclinical pelvic mesh testing, offering guidance that is crucial for enhancing the safety and efficacy of novel surgical interventions in the treatment of POP.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

The use of animal models in preclinical investigations for the development of a surgical mesh for pelvic organ prolapse

Seifalian,

Digesu,

Khullar

2024

Int Urogynecol J

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“…This section will only mention the novel devices that have reached preclinical animal trials for the application of pelvic surgery. Polycaprolactone (PCL) has the greatest volume of published research regarding application with animal studies showing promising results [ 53 , 54 , 55 , 56 , 57 ], including further experimental studies combining PCL with stem cells to augment the results [ 58 , 59 ]. Biodegradable PCL has also been included in experimental studies, although results found that degradation of the mesh occurred faster than tissue regeneration, hence, the higher risks of implant failure [ 60 ].…”

Section: Future Directionmentioning

confidence: 99%

Polypropylene Pelvic Mesh: What Went Wrong and What Will Be of the Future?

et al. 2023

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Background: Polypropylene (PP) pelvic mesh is a synthetic mesh made of PP polymer used to treat pelvic organ prolapse (POP). Its use has become highly controversial due to reports of serious complications. This research critically reviews the current management options for POP and PP mesh as a viable clinical application for the treatment of POP. The safety and suitability of PP material were rigorously studied and critically evaluated, with consideration to the mechanical and chemical properties of PP. We proposed the ideal properties of the ‘perfect’ synthetic pelvic mesh with emerging advanced materials. Methods: We performed a literature review using PubMed/Medline, Embase, Cochrane Library (Wiley) databases, and ClinicalTrials.gov databases, including the relevant keywords: pelvic organ prolapse (POP), polypropylene mesh, synthetic mesh, and mesh complications. Results: The results of this review found that although PP is nontoxic, its physical properties demonstrate a significant mismatch between its viscoelastic properties compared to the surrounding tissue, which is a likely cause of complications. In addition, a lack of integration of PP mesh into surrounding tissue over longer periods of follow up is another risk factor for irreversible complications. Conclusions: PP mesh has caused a rise in reports of complications involving chronic pain and mesh exposure. This is due to the mechanical and physicochemical properties of PP mesh. As a result, PP mesh for the treatment of POP has been banned in multiple countries, currently with no alternative available. We propose the development of a pelvic mesh using advanced materials including emerging graphene-based nanocomposite materials.

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Comparison of pathomorphologic properties of non-resorbable and partially resorbable implants for reconstructive surgery of pelvic organ prolapse and stress urinary incontinence: an animal model study

Shkarupa,

Shakhaliev,

Shulgin

et al. 2024

Vestn. Urol.

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Introduction. It is well-known that the use of transvaginal mesh implants is not devoid of specific complications that meaningfully impair the quality of life of female patients. The volume of permanent material used has been shown to correlate closely with the risk of implant-associated complications. Thus, there is a need to develop a new generation of implants that retain the advantages of a permanent mesh implant but with minimal risk of implant-associated complications. Meanwhile, there are insufficient data on the organism's response to this type of synthetic implant.Objective. To compare the histological changes in the soft tissues of the rabbit anterior abdominal wall in the implantation zone of the new generation partially resorbable implant and non-absorbable polypropylene mesh implant on the animal model.Materials & methods. We have previously developed a partially resorbable ligature delivery system for axial fixation of pelvic floor structures, performed technical analysis, and compared biomechanical and pathomorphological properties after implantation in an animal model experiment. The present study was conducted on 39 male rabbits of Chinchilla breed, randomised into three groups according to the type of implanted material: a partially resorbable ligature delivery system Axilen and Axilen Rapid [Lintex, LLC], and a non-resorbable polypropylene mesh implant Urosling. After the rabbits were removed from the experiment, the obtained biomaterial was subjected to histological study.Results. In the group with partially resorbable implants Axilen and Axilen Rapid, less inflammation and better tissue integration were observed compared to the polypropylene implant Urosling. This indicates a potential reduction in the risk of postoperative complications and an improvement in the quality of life for patients.Conclusion. The results of the experimental study confirm the advantages of using partially resorbable implants over traditional polypropylene meshes in pelvic floor reconstructive surgery. However, further research is needed to confirm the long-term safety and effectiveness of the new generation of implants.

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Features of In Vitro Degradation and Physical Properties of a Biopolymer and In Vivo Tissue Reactions in Comparison with Polypropylene

Cited by 3 publications

References 7 publications

The use of animal models in preclinical investigations for the development of a surgical mesh for pelvic organ prolapse

The use of animal models in preclinical investigations for the development of a surgical mesh for pelvic organ prolapse

Polypropylene Pelvic Mesh: What Went Wrong and What Will Be of the Future?

Comparison of pathomorphologic properties of non-resorbable and partially resorbable implants for reconstructive surgery of pelvic organ prolapse and stress urinary incontinence: an animal model study

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