| Use of vaginal mesh in the face of recent FDA warnings and litigation. | |
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MedLine Citation:
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PMID: 20227672 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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Choosing to use mesh in vaginal reconstructive surgery for pelvic organ prolapse or stress urinary incontinence is perplexing in the face of recent US Food and Drug Administration (FDA) warnings. In October 2008, the FDA alerted practitioners to complications associated with transvaginal placement of surgical mesh. Litigation is another concern. A Google search of "transvaginal mesh" results in numerous hits for plaintiff attorneys seeking patients with complications related to use of mesh. In light of a recent decision by the US Supreme Court and strategies by manufactures of medical devices to escape liability, it is imperative that gynecologic surgeons using transvaginal mesh document proper informed consent in the medical records. The purpose of this commentary is not to deter gynecologic surgeons from using transvaginal mesh when appropriate, but to provide an overview of current medical-legal controversies and stress the importance of documenting informed consent. |
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Authors:
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Sara J Mucowski; Catalin Jurnalov; John Y Phelps |
Publication Detail:
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Type: Journal Article; Review Date: 2010-03-15 |
Journal Detail:
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Title: American journal of obstetrics and gynecology Volume: 203 ISSN: 1097-6868 ISO Abbreviation: Am. J. Obstet. Gynecol. Publication Date: 2010 Aug |
Date Detail:
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Created Date: 2010-07-27 Completed Date: 2010-08-17 Revised Date: 2011-08-29 |
Medline Journal Info:
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Nlm Unique ID: 0370476 Medline TA: Am J Obstet Gynecol Country: United States |
Other Details:
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Languages: eng Pagination: 103.e1-4 Citation Subset: AIM; IM |
Copyright Information:
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Copyright (c) 2010 Mosby, Inc. All rights reserved. |
Affiliation:
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Department of Obstetrics and Gynecology, The University of Texas Medical Branch, Galveston, TX 77555-0587, USA. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Attitude of Health Personnel Female Humans Informed Consent / legislation & jurisprudence* Jurisprudence Physician's Practice Patterns Postoperative Complications / epidemiology, etiology* Prosthesis Failure Risk Assessment Suburethral Slings / adverse effects* Surgical Mesh / adverse effects*, utilization United States United States Food and Drug Administration / legislation & jurisprudence Urinary Incontinence, Stress / diagnosis, surgery* Uterine Prolapse / diagnosis, surgery* |
| Comments/Corrections | |
Comment In:
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Am J Obstet Gynecol. 2011 Mar;204(3):e6; author reply e6
[PMID:
21111395
]
Am J Obstet Gynecol. 2011 Jun;204(6):e10; author reply e10-1 [PMID: 21292232 ] |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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