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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...
| Autores principales: | , , , , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
BMJ Publishing Group
2017
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| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5728256/ https://www.ncbi.nlm.nih.gov/pubmed/29212782 http://dx.doi.org/10.1136/bmjopen-2017-017125 |