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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Publicado en:BMJ Open
Autores principales: Heneghan, Carl J, Goldacre, Ben, Onakpoya, Igho, Aronson, Jeffrey K, Jefferson, Tom, Pluddemann, Annette, Mahtani, Kamal R
Formato: Artigo
Lenguaje:Inglês
Publicado: BMJ Publishing Group 2017
Materias:
Surgery
Acceso en línea: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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