Open-label, Multi-center, Clinical trial to Evaluate Safety and Efficacy of Cohesive Gel-Filled Breast Implants UNIGEL® Targeting of Women from 22 to 60 Aged with regard to Augmentation Mammaplasty for Purpose of Cosmetic Surgery.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
69
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
a rate of rupture of 4%
Time frame: 2 years
a rate of capsular contracture of 10%
Time frame: 2 years
Kaplan-Meier Analysis of rupture or capsular contracture events
Time frame: 2 years
Change in nipple sensitivity
Time frame: 2 years
a rate of adverse evnets
Time frame: 2 years
Change in chest, bust and under bust circumference
Time frame: 2 years
SF-36(Short Form (36) Health Survey ), Evaluation of quality of life
Time frame: 2 years
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