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The Role of Vaginal Mesh Procedures in Pelvic Organ Prolapse Surgery in View of Complication Risk
Synthetic transvaginal mesh has been employed in the treatment of pelvic organ prolapse for more than a decade. As the use of these devices increased during this period so did adverse event reporting. In 2008, the Food and Drug Administration (FDA) Public Health Notification informed physicians and...
Autores principales: | , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Hindawi Publishing Corporation
2013
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3771437/ https://www.ncbi.nlm.nih.gov/pubmed/24069035 http://dx.doi.org/10.1155/2013/356960 |
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author | Ellington, David R. Richter, Holly E. |
author_facet | Ellington, David R. Richter, Holly E. |
author_sort | Ellington, David R. |
collection | PubMed |
description | Synthetic transvaginal mesh has been employed in the treatment of pelvic organ prolapse for more than a decade. As the use of these devices increased during this period so did adverse event reporting. In 2008, the Food and Drug Administration (FDA) Public Health Notification informed physicians and patients of rising concerns with the use of synthetic transvaginal mesh. Shortly thereafter and in parallel to marked increases in adverse event reporting within the Manufacturer and User Device Experience (MAUDE), the FDA released a Safety Communication regarding urogynecologic surgical mesh use. Following this report and in the wake of increased medical industry product withdrawal, growing medicolegal concerns, patient safety, and clinical practice controversy, many gynecologists and pelvic reconstructive surgeons are left with limited long-term data, clinical guidance, and growing uncertainty regarding the role of synthetic transvaginal mesh use in pelvic organ prolapse. This paper reviews the reported complications of synthetic transvaginal mesh with an evidence-based approach as well as providing suggested guidance for the future role of its use amidst the controversy. |
format | Online Article Text |
id | pubmed-3771437 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2013 |
publisher | Hindawi Publishing Corporation |
record_format | MEDLINE/PubMed |
spelling | pubmed-37714372013-09-25 The Role of Vaginal Mesh Procedures in Pelvic Organ Prolapse Surgery in View of Complication Risk Ellington, David R. Richter, Holly E. Obstet Gynecol Int Review Article Synthetic transvaginal mesh has been employed in the treatment of pelvic organ prolapse for more than a decade. As the use of these devices increased during this period so did adverse event reporting. In 2008, the Food and Drug Administration (FDA) Public Health Notification informed physicians and patients of rising concerns with the use of synthetic transvaginal mesh. Shortly thereafter and in parallel to marked increases in adverse event reporting within the Manufacturer and User Device Experience (MAUDE), the FDA released a Safety Communication regarding urogynecologic surgical mesh use. Following this report and in the wake of increased medical industry product withdrawal, growing medicolegal concerns, patient safety, and clinical practice controversy, many gynecologists and pelvic reconstructive surgeons are left with limited long-term data, clinical guidance, and growing uncertainty regarding the role of synthetic transvaginal mesh use in pelvic organ prolapse. This paper reviews the reported complications of synthetic transvaginal mesh with an evidence-based approach as well as providing suggested guidance for the future role of its use amidst the controversy. Hindawi Publishing Corporation 2013 2013-08-28 /pmc/articles/PMC3771437/ /pubmed/24069035 http://dx.doi.org/10.1155/2013/356960 Text en Copyright © 2013 D. R. Ellington and H. E. Richter. https://creativecommons.org/licenses/by/3.0/ This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Review Article Ellington, David R. Richter, Holly E. The Role of Vaginal Mesh Procedures in Pelvic Organ Prolapse Surgery in View of Complication Risk |
title | The Role of Vaginal Mesh Procedures in Pelvic Organ Prolapse Surgery in View of Complication Risk |
title_full | The Role of Vaginal Mesh Procedures in Pelvic Organ Prolapse Surgery in View of Complication Risk |
title_fullStr | The Role of Vaginal Mesh Procedures in Pelvic Organ Prolapse Surgery in View of Complication Risk |
title_full_unstemmed | The Role of Vaginal Mesh Procedures in Pelvic Organ Prolapse Surgery in View of Complication Risk |
title_short | The Role of Vaginal Mesh Procedures in Pelvic Organ Prolapse Surgery in View of Complication Risk |
title_sort | role of vaginal mesh procedures in pelvic organ prolapse surgery in view of complication risk |
topic | Review Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3771437/ https://www.ncbi.nlm.nih.gov/pubmed/24069035 http://dx.doi.org/10.1155/2013/356960 |
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