The transvaginal mesh decade

Maher, Christopher F. and Haya, Nir (2013) The transvaginal mesh decade. Expert Review of Obstetrics & Gynecology, 8 5: 485-492. doi:10.1586/17474108.2013.825476


Author Maher, Christopher F.
Haya, Nir
Title The transvaginal mesh decade
Journal name Expert Review of Obstetrics & Gynecology   Check publisher's open access policy
ISSN 1747-4108
1747-4116
Publication date 2013-01-01
Sub-type Article (original research)
DOI 10.1586/17474108.2013.825476
Open Access Status Not yet assessed
Volume 8
Issue 5
Start page 485
End page 492
Total pages 8
Place of publication Abingdon, Oxfordshire United Kingdom
Publisher Taylor & Francis
Language eng
Abstract During the transvaginal mesh era some women have suffered unexpectedly poor outcomes following the insertion of transvaginal mesh for the surgical management of pelvic organ prolapse. To minimize the risk of these events repeating, we support changes to approval process of new devices including premarket demonstration of safety and efficacy. Clinicians should demonstrate greater vigilance in the introductory phase of new technologies including incorporating ethics committee approval for procedures without adequate safety and efficacy data. Formalization of an ‘arm’s length’ relationship between clinicians and industry would help minimize conflicts of interest which may unduly bias the introduction of new technologies and create improved transparency and confidence. Colleges and educational societies where the elected representatives are free of any relationship with industry could facilitate the ‘arm’s length’ relationship between clinician and industry that our community demands. These changes to regulatory approval, caution in the introduction of new technologies and greater transparency surrounding the relationship between industry and clinicians should minimize the risk of patients suffering significant unforeseen complications and poor outcomes.
Keyword complications
pelvic organ prolapse surgery
transvaginal mesh
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collection: School of Medicine Publications
 
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Created: Fri, 21 Apr 2017, 16:41:57 EST by Christopher Maher on behalf of Royal Brisbane Clinical Unit