Six-Year Prospective Outcomes of Primary Breast Augmentation With Nano Surface Implants.

[BACKGROUND] Motiva Implants (Establishment Labs Holdings Inc.) are a novel family of silicone breast implants using cutting-edge technologies engineered to optimize aesthetic and safety outcomes.

[OBJECTIVES] The authors sought to prospectively evaluate the safety and effectiveness of SmoothSilk/SilkSurface Motiva Implants over long-term follow-up.

[METHODS] Surgeons at a single plastic surgery center undertook a 10-year follow-up study of SmoothSilk/SilkSurface Motiva Implants in women who underwent primary breast augmentation. Safety was assessed through identification of complications on follow-up and through magnetic resonance imaging (MRI) in a representative sample. Effectiveness outcomes were assessed by surgeons and patients using Likert scales and a Quality of Life tool.

[RESULTS] This article reports the 6-year safety and effectiveness outcomes. A total of 35 patients were implanted between September and December 2010, and 71.9% of implants were placed submuscularly using inframammary incision. During the 6-year follow-up, there were no occurrences of capsular contracture, rupture, double capsules, or late seroma. MRI evaluation identified no signs of implant-related complications. Three revision surgeries were performed, all for aesthetic reasons; there were no implant replacements for medical reasons. The level of satisfaction for both patients and surgeons was high at all follow-up visits. Patient quality-of-life scores increased following breast augmentation by an average of 0.89% at 72 months.

[CONCLUSIONS] The results of this prospective long-term follow-up study demonstrate the excellent safety and effectiveness of SmoothSilk/SilkSurface Motiva Implants in primary breast augmentation through 6 years of follow-up.