Zaussinger Maximilian, Duscher Dominik, Huemer Georg M
Medical Faculty, Johannes Kepler University Linz, Altenbergerstr. 69, 4040 Linz, Austria.
Section of Plastic, Aesthetic and Reconstructive Surgery, Kepler University Hospital Linz, Krankenhausstrasse 9, 4020 Linz, Austria.
J Clin Med. 2023 May 27;12(11):3708. doi: 10.3390/jcm12113708.
For decades, implant-based breast augmentation has been one of the most performed surgical procedures for cosmetic purposes around the world. Hence, novel manufactured implants should be critically investigated to prove them safe and effective. Here, the authors describe the first independently conducted clinical study on Nagor Impleo textured round breast implants. For this retrospective study, outcomes of 340 consecutive female patients undergoing primary cosmetic breast augmentation were analyzed. Demographic and surgical data as well as outcomes and complications were evaluated. Furthermore, a survey concerning effectiveness and aesthetic satisfaction after breast augmentation was examined. All 680 implants were placed in a submuscular plane with incisions at the inframammary fold. The main indications for surgery were hypoplasia and hypoplasia with asymmetry. The mean implant volume was 390 cc and the main type of projection was high profile. The most common complications were hematoma and capsular contracture (0.9 percent, respectively). The overall revision rate for complications was 2.4%. Additionally, almost all patients showed increased quality of life and aesthetic satisfaction after a breast augmentation. Hence, all patients would undergo breast augmentation again with these newly launched devices. Nagor Impleo implants demonstrate a low complication rate and high safety profile. Although high aesthetic satisfaction and quality of life results were achieved, analysis of an even larger series over a longer period of time would be beneficial to evaluate the reliability of this implant.
几十年来，基于植入物的隆胸手术一直是全球最常开展的美容外科手术之一。因此，对于新生产的植入物应进行严格研究，以证明其安全性和有效性。在此，作者描述了第一项关于Nagor Impleo表面有纹理的圆形乳房植入物的独立临床研究。在这项回顾性研究中，分析了340例连续接受初次美容隆胸手术的女性患者的手术结果。评估了人口统计学和手术数据以及手术结果和并发症。此外，还调查了隆胸术后的有效性和美学满意度。所有680枚植入物均置于胸大肌下平面，切口位于乳房下皱襞处。手术的主要适应症为乳房发育不全以及伴有不对称的乳房发育不全。植入物的平均体积为390立方厘米，主要的突起类型为高突型。最常见的并发症是血肿和包膜挛缩（发生率均为0.9%）。并发症的总体翻修率为2.4%。此外，几乎所有患者在隆胸术后生活质量提高，美学满意度增强。因此，所有患者都愿意再次使用这些新推出的器械进行隆胸手术。Nagor Impleo植入物显示出较低的并发症发生率和较高的安全性。尽管取得了较高的美学满意度和生活质量结果，但分析更长时间内更大样本量的数据将有助于评估这种植入物的可靠性。
