High-resolution Ultrasound-assisted Assessment of Preliminary Short-term Safety Outcomes of an Implant-based Augmentation Mammaplasty using a Bioengineered, Cell-friendly, Smooth-surface Device in Korean Women
Abstract Background The Motiva Ergonomix™ Round SilkSurface (Establishment Labs Holdings Inc., Alajuela, Costa Rica) is one the representative brands of the fifth-generation of a silicone gel-filled breast implant with a microtextured surface. Objectives In this study, we describe preliminary short-term safety outcomes of an implant-based augmentation mammaplasty using the Motiva Ergonomix™ Round SilkSurface in Korean women. Methods We performed a retrospective analysis of medical records in a total of 69 women (n=69) receiving an implant-based augmentation mammaplasty using the Motiva Ergonomix™ Round SilkSurface between September 26, 2017 and December 31, 2020. We analyzed incidences of postoperative complications. Results A total of 6 cases (8.7%) of postoperative complications occurred; these include 2 cases (2.9%) of early seroma, 1 case (1.4%) of capsular contracture, 2 cases (2.9%) of alterations in the shape and 1 case (1.4%) of foreign body sensation. Time-to-events were estimated at 266.81±273.17 days. Conclusions We describe our preliminary short-term safety outcomes of an implant-based augmentation mammaplasty using the Motiva Ergonomix TM Round SilkSurface in Korean women. But this deserves further large-scale studies with long periods of follow-up.