Anesthetist in private practice in San Jose, Costa Rica.
Aesthet Surg J. 2019 Apr 8;39(5):495-508. doi: 10.1093/asj/sjy196.
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.
Motiva 植入物（Establishment Labs Holdings Inc.）是一种新型的硅胶乳房植入物，采用先进的技术，旨在优化美容和安全效果。
作者旨在前瞻性评估 SmoothSilk/SilkSurface Motiva 植入物在长期随访中的安全性和有效性。
一家整形手术中心的外科医生对接受初次乳房隆乳术的女性进行了为期 10 年的 SmoothSilk/SilkSurface Motiva 植入物随访研究。通过随访中发现的并发症和对代表性样本进行磁共振成像（MRI）来评估安全性。外科医生和患者使用李克特量表和生活质量工具评估有效性结果。
本文报告了 6 年的安全性和有效性结果。2010 年 9 月至 12 月期间共植入了 35 例患者，71.9%的植入物采用经乳晕下切口的胸肌下植入。在 6 年的随访中，没有发生包膜挛缩、破裂、双层包膜或迟发性血清肿。MRI 评估未发现与植入物相关的并发症迹象。进行了 3 次修复手术，均为美容原因；没有因医疗原因更换植入物。在所有随访时，患者和外科医生的满意度均很高。患者生活质量评分在 72 个月时平均增加了 0.89%。
这项前瞻性长期随访研究的结果表明，SmoothSilk/SilkSurface Motiva 植入物在初次乳房隆乳中具有出色的安全性和有效性，在 6 年的随访中得到了证实。
