New strategies to improve results of mesh surgeries for vaginal prolapses repair – an update

Dias, Fernando Goulart Fernandes; Dias, Paulo Henrique Goulart Fernandes; Prudente, Alessandro; Riccetto, Cássio

doi:10.1590/s1677-5538.ibju.2014.0163

Cited by 10 publications

(16 citation statements)

References 62 publications

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“…Thus, absorbable meshes are not indicated when prolonged tensile strength is required. Also, as evaluated in randomized trials, polyglycolic acid, and polyglactin 910 absorbable meshes were found to be associated with high recurrence rates in prolapse surgery (Dias, Dias, Prudente, & Riccetto, ).…”

Section: Synthetic Meshes: Materialsmentioning

confidence: 99%

“…In a move toward more biosynthetic meshes, approaches such as collagen coating of polypropylene have been explored. Collagen‐based biomaterials have been available for several decades and are becoming increasingly popular due to their perceived biocompatibility and low immunogenicity (Dias et al, ; Sternschuss, Ostergard, & Patel, ). However, results and outcomes for collagen based implants vary substantially when translated from and between animal models to the actual clinical applications (Dlaska et al, ; Meimandi‐Parizi, Oryan, Moshiri, & Silver, ).…”

Section: Synthetic Meshes: Surface Treatmentsmentioning

confidence: 99%

“…These problems present real opportunities for the application of new research from the biomaterials and tissue engineering field (Chapple, Osman, Mangera, et al, ). Recent literature highlights that researchers are exploring the capabilities of nanofiber‐based scaffolds to develop meshes able to (a) enhance tissue remodeling (promoting fibroblast ingrowth, extracellular matrix production, and angiogenesis), (b) provide tensile support and (c) remain elastic to allow natural movement of vaginal tissue (Bissoli & Bruschini, ; Chapple et al, ; Dias et al, ; Roman et al, ).…”

Section: Future Perspectivementioning

confidence: 99%

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The use of polymeric meshes for pelvic organ prolapse: Current concepts, challenges, and future perspectives

et al. 2019

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Pelvic organ prolapse (POP) is one of the most common chronic disorders in women, impacting the quality of life of millions of them worldwide. More than 100 surgical procedures have been developed over the decades to treat POP. However, the failure of conservative strategies and the number of patients with recurrence risk have increased the need for further adjuvant treatments. Since their introduction, surgical synthetic meshes have dramatically transformed POP repair showing superior anatomic outcomes in comparison to traditional approaches. Although significant progress has been attained, among the meshes in clinical use, there is no single mesh appropriate for every surgery. Furthermore, due to the risk of complications including acute and chronic infection, mesh shrinkage, and erosion of the tissue, the benefits of the use of meshes have recently been questioned. The aim of this work is to review the evolution of POP surgery, analyzing the current challenges, and detailing the key factors pertinent to the design of new mesh systems. Starting with a description of the pelvic floor anatomy, the article then presents the traditional treatments used in pelvic organ disorders. Next, the development of synthetic meshes is described with an insight into how their function is dependent on both mesh design variables (i.e., material, structure, and functional treatment) and surgical applications. These are then linked to common mesh‐related complications, and an indication of current research aiming to address these issues.

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Section: Synthetic Meshes: Materialsmentioning

confidence: 99%

Section: Synthetic Meshes: Surface Treatmentsmentioning

confidence: 99%

Section: Future Perspectivementioning

confidence: 99%

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The use of polymeric meshes for pelvic organ prolapse: Current concepts, challenges, and future perspectives

et al. 2019

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“…The FDA's recent decision to change the classification status [114] of vaginal mesh devices from Class II to Class III will require the manufacturers to conduct many more tests to show the safety of their devices [115]. Presumably, this will include a chemical characterization of the vaginal mesh material [116].…”

Section: Testingmentioning

confidence: 99%

The new U.S. FDA regulations on biocompatibility and reprocessing for medical devices

Reifschneider

2018

Preprint

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The U.S. Food and Drug Administration ("FDA") regulates all medical devices in the United States. As part of its regulatory duties, the FDA provides guidance documents on various regulatory topics as mandated by the U.S. code of federal regulations. Since 2015, the FDA has begun to issue many substantial revisions to their guidance documents that directly affects the regulatory framework on biocompatibility, reprocessing, and sterilization.These regulatory issues are of paramount importance for many companies because of the potential high costs involved in changing their internal design, controls, manufacturing, and quality systems. This master’s thesis examines the various changes made by the FDA in recent years on the inter-related topics of biocompatibility, reprocessing, and sterilization. Some of the major changes by the FDA involve an increase in the importance of chemical characterization, a reduction in the use of animal testing, a requirement for an independent validation of the user instructions for reusable devices, and increased usability testing.The principal reasons for these major policy changes by the FDA are shown to be the major device scandals that recently involved duodenoscopes, metal-on-metal hip implants, and vaginal surgical mesh implants. Along with several other regulatory failures that made national news headlines in the United States, the FDA began to revise several of their previous medical device guidances. The information from this master’s thesis can be used by medical device developers and manufacturers, especially when they are located outside of the United States and lack sufficient regulatory affairs resources to provide independent advice and recommendations on these important FDA changes. A thorough analysis is made of the new FDA guidances to clarify several potentially difficult questions for medical device manufacturers, specifically the following: (1) "Use of International Standard ISO 10993-1, ‘Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", (2) "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling", and (3) "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile". This master’s thesis is intended to provide not only an overview of the current FDA requirements, but to function as a guide for both researchers and engineers to improve their medical device design and development process.

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“…Higher prevalence rate was met when it was used the biological grafts (14) . One study shows that xenogenic graft was more superior to polypropylene mesh.…”

Section: The Role Of Synthetic Graftsmentioning

confidence: 99%

The role of vaginal graft procedures in pelvic organ prolapse reconstructive surgery

Badiu¹

2017

Gineco.eu

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Pelvic organ prolapse (POP) represents a risk in women who undergo surgical intervention such as histerectomy. In order to treat it, many surgeons started to use grafts implants in reconstruction of the pelvis. The latest studies showed the development of new grafts era, supporting its beneficial effect for the patients. In this respect, the treatment should be individualized and in particular cases the use of grafts should be taken into consideration. When comparing the graft with native tissue repair, the application of surgery on POP have been shown similar anatomical restoration, and grafts were attributed more complications, especially in the transvaginal implant. Although nowadays grafts represent the best tool for prolapsed repair, the ideal implant has not yet been developed. The present review tries to explain the role of synthetic or biological grafts and the therapeutic approaches of the POP.

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New strategies to improve results of mesh surgeries for vaginal prolapses repair – an update

Cited by 10 publications

References 62 publications

The use of polymeric meshes for pelvic organ prolapse: Current concepts, challenges, and future perspectives

The use of polymeric meshes for pelvic organ prolapse: Current concepts, challenges, and future perspectives

The new U.S. FDA regulations on biocompatibility and reprocessing for medical devices

The role of vaginal graft procedures in pelvic organ prolapse reconstructive surgery

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