Details for the study
Brief Title
Open-label, Multi-center Trial to Evaluate Safety and Efficacy of Cohesive Silicone Gel-Filled Breast Implants UNIGEL®
Brief Summary
Open-label, Multi-center, Clinical trial to Evaluate Safety and Efficacy of Cohesive
<br /> Gel-Filled Breast Implants UNIGEL® Targeting of Women from 22 to 60 Aged with regard to
<br /> Augmentation Mammaplasty for Purpose of Cosmetic Surgery.
Study Criteria
Inclusion Criteria:
- Has given written informed consent to entry
- Female, 22 years to 60 years
- Breast augmentation(cosmetic surgery) is for following subjects
- Who is not content with breast size and shape
- Who has congenital asymmetrical deformity
- subject who agree to MRI scan during the trial
- subject who agree to visit to hospital according to schedule specified in the protocol
during the entire period of the trial
Exclusion Criteria:
- Pregnant or lactating women and women of childbearing age
- Subject who has operation history of breast augmentation or reconstruction
- Subject who has fibrocystic Breast Disease coming up for precancerous lesion not
accompanied with subcutaneous mastectomy
- Subject who has breast cancer or prodromal phase and no proper treatment.
- Subject who is diagnosed with Breast Imaging-Reporting and Data System(BI-RADS)
category 3 under breast ultrasonography.
- Subject who has uncontrolled active infectious disease or abscess
- Autoimmune disease
- Diabetes mellitus
- Keloidosis
- Subject who cannot take general anesthesia due to abnormal blood or ECG results.
- Subject who is not appropriate for breast augmentation due to damaged tissue or blood
vessel or ulcer
- Subject who has metal materials in a body such as ventricular assist system or
cerebral aneurysm clips, or has claustrophobia (not suitable for MRI SCAN)
- Physically/mentally disabled subject that may disturb understanding and cooperation
for the trial.
- Any other conditions that may interfere with correct assessment of the trial.
