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

Abstract

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. Previous minimally invasive approaches have failed to provide long-term safety, effectiveness, and patient satisfaction. The authors of this study introduce a minimally invasive breast harmonization procedure, performed with an inflatable balloon and a biconvex-shaped silicone-filled implant, addressing these limitations with a safe and innovative solution. In this prospective controlled study, the authors evaluate the safety and effectiveness of this procedure, reducing surgical complications while providing a new treatment option for breast enhancement. A 3-year, IRB-approved study enrolled 100 participants undergoing this procedure, utilizing an axillary incision with prepectoral implant placement. Safety was assessed by monitoring the cumulative incidence of postoperative complications in scheduled visits and with MRI evaluations in a randomized subcohort (33 participants). Patient satisfaction was measured pre- and postprocedure using Breast-Q questionnaires and scar evaluation with the Patient and Observer Scar Assessment Scale. Effectiveness endpoint at 3 years reported a 75.3% bra increase of 1 to 3 cup sizes. The overall Kaplan-Meier complication rate at 3 years was 3.2%, with low reoperation 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 breast implant-associated anaplastic large cell lymphoma. This study demonstrates very low complication rates, faster recovery, and enhanced patient satisfaction with this procedure compared with conventional breast augmentation. Its minimally invasive tissue-preservation approach introduces new surgical concepts, advancing surgical techniques and technologies beyond conventional methods. : 4 (Therapeutic).