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Transvaginal mesh failure: lessons for regulation of implantable devices.

Abstract:
Concern is increasing that use of transvaginal mesh devices to treat stress urinary incontinence and pelvic organ prolapse has exposed women to avoidable harms. Part of the problem may lie with the governance of medical devices, which has enabled new devices to be brought to market with inadequate evidence, and over 100 000 litigation cases are now under way.1 We consider how improvements to both regulatory approvals and the structures supporting evidence based practice among clinicians could help prevent similar problems in the future.
Publication status:
Published
Peer review status:
Peer reviewed

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Publisher copy:
10.1136/bmj.j5515

Authors


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Institution:
University of Oxford
Division:
Medical Sciences Division
Department:
Primary Care; Primary Care Health Sciences
Oxford college:
Kellogg College
Role:
Author
More by this author
Institution:
University of Oxford
Division:
Medical Sciences Division
Department:
Primary Care; Primary Care Health Sciences
Role:
Author
More by this author
Institution:
University of Oxford
Division:
Medical Sciences Division
Department:
Primary Care; Primary Care Health Sciences
Role:
Author
More by this author
Institution:
University of Oxford
Division:
MSD
Department:
Primary Care Health Sciences
Role:
Author
More by this author
Institution:
University of Oxford
Division:
Medical Sciences Division
Department:
Primary Care; Primary Care Health Sciences
Role:
Author
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Publisher:
BMJ Publishing Group Publisher's website
Journal:
BMJ Journal website
Volume:
359
Pages:
j5515
Publication date:
2017-12-01
Acceptance date:
2017-11-06
DOI:
EISSN:
1756-1833
ISSN:
0959-8138
Pmid:
29217786
Source identifiers:
810860
Language:
English
Keywords:
Pubs id:
pubs:810860
UUID:
uuid:11925495-37a8-46c0-a39c-851ffafb88a6
Local pid:
pubs:810860
Deposit date:
2018-02-25

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