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...

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Detalhes bibliográficos
Publicado no:BMJ Open
Main Authors: Heneghan, Carl J, Goldacre, Ben, Onakpoya, Igho, Aronson, Jeffrey K, Jefferson, Tom, Pluddemann, Annette, Mahtani, Kamal R
Formato: Artigo
Idioma:Inglês
Publicado em: BMJ Publishing Group 2017
Assuntos:
Surgery
Acesso em linha: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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