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Trials of transvaginal mesh devices for pelvic organ prolapse: a systematic database review of the US FDA approval process

INTRODUCTION: 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 approv...

詳細記述

保存先:
書誌詳細
出版年:BMJ Open
主要な著者: Heneghan, Carl J, Goldacre, Ben, Onakpoya, Igho, Aronson, Jeffrey K, Jefferson, Tom, Pluddemann, Annette, Mahtani, Kamal R
フォーマット: Artigo
言語:Inglês
出版事項: BMJ Publishing Group 2017
主題:
オンライン・アクセス:https://ncbi.nlm.nih.gov/pmc/articles/PMC5728256/
https://ncbi.nlm.nih.gov/pubmed/29212782
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1136/bmjopen-2017-017125
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