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

2018; Oxford University Press; Volume: 39; Issue: 5 Linguagem: Inglês

10.1093/asj/sjy196

1527-330X

Manuel Chacón Quirós, Manuel Chacón Bolaños, Jeffry James Fassero,

Craniofacial Disorders and Treatments

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