The 3-Year Results of a 100-Patient Prospective Study of Safety and Effectiveness of Mia Femtech

Abstract Background Conventional breast augmentation using different approaches and implant pockets faces challenges such as societal stigma, long recovery time, invasion of the breast, and complication rates. Prior minimally invasive approaches have failed to provide long-term safety, effectiveness, and patient satisfaction. This study introduces a minimally invasive breast harmonization procedure, performed with an inflatable balloon and a bi-convex-shaped silicone-filled implant, addressing these limitations with a safe and innovative solution. Objectives This prospective controlled study evaluates the safety and effectiveness of this procedure, reducing surgical complications while providing a new treatment option for breast enhancement. Methods A three-year, IRB-approved study enrolled 100 subjects undergoing this procedure, utilizing an axillary incision with prepectoral implant placement. Safety was assessed by monitoring the cumulative incidence of post-operative complications in scheduled visits and with MRI evaluations in a randomized sub-cohort (33 participants). Patient satisfaction was measured pre- and post-procedure using Breast-Q questionnaires and scar evaluation with POSAS. Results Effectiveness endpoint at 3 years reported a 75.3% bra increase of one to three cup sizes. The overall Kaplan-Meier complication rate at 3 years was 3.2%, with low re-operation rates and 93% follow-up compliance. There were no patient reports of nipple or breast sensitivity loss, nor surgeon reported incision-related complications, implant rupture, capsular contracture (Baker Grade III/IV), infection, seroma, rippling, hematoma, or BIA-ALCL. Conclusions This study demonstrates very low complication rates, faster recovery, and enhanced patient satisfaction with this procedure, compared to conventional breast augmentation. Its minimally invasive tissue-preservation approach introduces new surgical concepts, advancing surgical techniques and technologies beyond conventional methods.