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...

Descrizione completa

Salvato in:
Dettagli Bibliografici
Pubblicato in:BMJ Open
Autori principali: Heneghan, Carl J, Goldacre, Ben, Onakpoya, Igho, Aronson, Jeffrey K, Jefferson, Tom, Pluddemann, Annette, Mahtani, Kamal R
Natura: Artigo
Lingua:Inglês
Pubblicazione: BMJ Publishing Group 2017
Soggetti:
Surgery
Accesso online: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
Tags: Aggiungi Tag
Nessun Tag, puoi essere il primo ad aggiungerne! !

Documenti analoghi