TERMIUM Plus®

The Government of Canada’s terminology and linguistic data bank.

ETUDE FONDAMENTALE [1 record]

Record 1 2008-01-03

English

Subject field(s)
  • Scientific Research
  • Surgery
DEF

The primary clinical study of [breast] augmentation, reconstruction, and revision (revision-augmentation and revision-reconstruction) patients.

OBS

Safety and effectiveness data are collected yearly through 10 years, with the follow-up from years 5 through 10 being performed as part of a postapproval core study.

French

Domaine(s)
  • Recherche scientifique
  • Chirurgie
DEF

Étude primaire clinique portant sur des patientes ayant subi une intervention d'augmentation, de reconstruction ou de révision (révision d'augmentation et révision de reconstruction).

CONT

Comme condition de l'homologation, Mentor doit suivre son étude de base de 1000 patientes sur dix ans, et doit entreprendre une vaste étude post-approbation visant à mesurer des événements potentiels rares à long terme.

Spanish

Campo(s) temático(s)
  • Investigación científica
  • Cirugía
CONT

Si durante el examen inicial, exámenes de laboratorio o valoración por el anestesiólogo se detectan riesgos importantes para su caso, con seguridad se le recomendará desistir de la operación, al menos mientras los riesgos desaparezcan.

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