Journal article
Trials of transvaginal mesh devices for pelvic organ prolapse: a systematic database review of the US FDA approval process.
- Abstract:
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Transvaginal mesh devices are approved in the USA by the Food and Drug Administration (FDA), through the 510(k) system. However, there is uncertainty about the benefit to harm balance of mesh approved for pelvic organ prolapse. We, therefore, assessed the evidence at the time of approval for transvaginal mesh products and the impact of safety studies the FDA mandated in 2012 because of emerging harms.We used FDA databases to determine the evidence for approval of transvaginal mesh. To create ...
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- Publication status:
- Published
- Peer review status:
- Peer reviewed
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(Preview, Version of record, pdf, 2.1MB, Terms of use)
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- Publisher copy:
- 10.1136/bmjopen-2017-017125
Authors
Bibliographic Details
- Publisher:
- BMJ Publishing Group
- Journal:
- BMJ Open More from this journal
- Volume:
- 7
- Issue:
- 12
- Pages:
- 1-9
- Publication date:
- 2017-12-06
- Acceptance date:
- 2017-11-24
- DOI:
- ISSN:
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2044-6055
- Pmid:
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29212782
Item Description
- Language:
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English
- Keywords:
- Pubs id:
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pubs:810861
- UUID:
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uuid:29ce0b5f-9002-4c39-a8cb-782db6c6fada
- Local pid:
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pubs:810861
- Source identifiers:
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810861
- Deposit date:
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2018-01-17
Terms of use
- Copyright holder:
- © Heneghan, et al 2017
- Copyright date:
- 2017
- Notes:
- This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
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