Improved Breast Enlargement Using the Subject's Own Fat Tissue

簡要摘要

The goal of this clinical study is to learn if the Medical Device Under Investigation (simply "the device") is safe to use in human adults undergoing breast augmentation surgery. The study will also show if the device can improve volume retention of the breast after the surgery. In the study, breast augmentation surgery will be done by transplanting the participant's own fatty tissue from the belly or buttocks to the breast. This surgical technique is also known as Structural Fat Grafting (SFG). The main questions this clinical study aims to answer is: * Is the use of the device safe in human? * Is the device fully degraded over time? * Does the use of the device during SFG improve breast volume retention, compared to standard SFG without the device. Thereto, 20 healthy female participants between the age of 18 and 55 years old will be included in this study. Half of the participants (10 out of 20) will undergo the surgery with the use of the device (treatment group) and the other 10 participants will undergo the surgery without the use of the device (control group). Participants will be followed up for 6 months after the surgery, with a possible extension to 9 months, and visit the hospital 6 to 7 times for checkups and tests.