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

BMJ Open

Volumn 7, Issue 12, 2017, Pages

  Heneghan, Carl J ^a   Goldacre, Ben ^a   Onakpoya, Igho ^a   Aronson, Jeffrey K ^a   Jefferson, Tom ^a,b   Pluddemann, Annette ^a   Mahtani, Kamal R ^a  

^a UNIVERSITY OF OXFORD   (United Kingdom)

^b Anguillara Sabazia ^*  (Italy)

Author keywords

fda; regulatory approval; transvaginal mesh

Indexed keywords

POLYETHYLENE TEREPHTHALATE;

ARTICLE; DATA BASE; DEVICE APPROVAL; DEVICE SAFETY; FOOD AND DRUG ADMINISTRATION; HUMAN; PELVIC ORGAN PROLAPSE; POSTMARKETING SURVEILLANCE; RANDOMIZED CONTROLLED TRIAL (TOPIC); SYSTEMATIC REVIEW; FACTUAL DATABASE; FEMALE; PROCEDURES; STATISTICS AND NUMERICAL DATA; SURGICAL MESH; UNITED STATES;

DATABASES, FACTUAL; DEVICE APPROVAL; FEMALE; HUMANS; PELVIC ORGAN PROLAPSE; PRODUCT SURVEILLANCE, POSTMARKETING; SURGICAL MESH; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 85044055637     PISSN: None     EISSN: 20446055     Source Type: Journal    
DOI: 10.1136/bmjopen-2017-017125     Document Type: Article

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