Open-label, Multi-center Trial to Evaluate Safety and Efficacy of Cohesive Silicone Gel-Filled Breast Implants UNIGEL®

Study Overview
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Brief Summary
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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.

Conditions
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Breast Augmentation

Intervention / Treatment
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* Device: UNIGEL Silicone Gel-Filled Breast Implant


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Breast Augmentation<br> | Device: UNIGEL Silicone Gel-Filled Breast Implant<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| a rate of rupture of 4% |  | 2 years | 
| a rate of capsular contracture of 10% |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kaplan-Meier Analysis of rupture or capsular contracture events |  | 2 years | 
| Change in nipple sensitivity |  | 2 years | 
| a rate of adverse evnets |  | 2 years | 
| Change in chest, bust and under bust circumference |  | 2 years | 
| SF-36(Short Form (36) Health Survey ), Evaluation of quality of life |  | 2 years |