Clinical Trial to Evaluate the Safety and Efficacy of Breast Implant

Clinical Trial to Evaluate the Safety and Efficacy of Cohesive Silicone Gel-Filled Breast Implant (CoSBI) in Women Aged 22 and Over With Breast Reconstruction or Augmentation Mammoplasty.

The aim of this study is to evaluate the safety and efficacy of Cohesive Silicone Gel-Filled Breast Implant (CoSBI) produced by HansBiomed co.,Ltd. in breast reconstruction or augmentation

Inclusion Criteria:

• Over 22 years of age
• Subjects who want breast augmentation reconstruction following breast cancer, congenital or accidental unbalanced breast size
• Negative pregnancy test in fertile women
• Subjects who voluntarily decided the participation of the study and signed the informed consent
• Subjects who can understand and comply with the instructions and participate during the entire period of the trial

Exclusion Criteria:

• previous breast reconstruction or augmentation history
• self -immune disease
• uncontrolled active infectious disease
• unable to insert beast implant due to radiotherapy
• Patients who have recurrent breast cancer or do not treat effectively their cancer
• Keloid
• Abnormal blood test or ECG result for general anesthesia
• Patients who cannot MRI scan due to having Metallic substance in the body or Claustrophobia
• Aesthetic addiction, drug abuse, alcohol abuse
• Patients who are not eligible for this study at the medical discretion of the Principal Investigator or Sub-investigator