Kooiman Laurens, Torensma Bart, Stevens Hieronymus, van der Lei Berend
Department of Plastic Surgery, Haaglanden Medical Centre (HMC), The Hague, the Netherlands.
Department of Anesthesiology and Epidemiology, Leiden University Medical Centre (LUMC), Leiden, the Netherlands.
Aesthet Surg J. 2022 Apr 12;42(5):NP282-NP292. doi: 10.1093/asj/sjab373.
Breast augmentation is one of the most commonly performed aesthetic plastic surgical procedures, with over 250,000 procedures in the United States in 2020 alone. However, the safety of breast implants should be closely researched and monitored, especially in the long term.
This study was undertaken to evaluate the long-term results of round micro-textured Eurosilicone (Eurosilicone S.A.S, Apt Cedex, France) Cristalline Paragel breast implants from a single-center, single-surgeon experience regarding both patient-reported outcome measures and revisions.
A retrospective cohort study was undertaken of 84 patients who underwent primary breast augmentation with round micro-textured Eurosilicone Cristalline Paragel breast implants, either submuscular (dual-plane) or subglandular placed, between 2001 and 2004. All patients were contacted for informed consent, and after approval, the validated BREAST-Q questionnaire was sent and utilized to analyze patient satisfaction. In addition, objective data regarding revisions, including capsular contracture, rupture rate, pain, and/or aesthetic causes needing revision surgery, were analyzed.
High BREAST-Q scores (67%-100% for 0-100 scale variables and 66.0%-77.3% of the patients scored "very satisfied" on categorical variables) were found without clinically significant differences between patients with dual-plane-placed implants and subglandular-placed implants. The overall revision rate was 29.8%, also with no significant differences between groups (P = 0.317).
This study showed high patient satisfaction and relatively low revision rates after 15 to 19 years of follow-up of round micro-textured Eurosilicone Cristalline Paragel breast implants. No clinically relevant significant differences were found between dual-plane and subglandular placement of the implants.
隆胸是最常见的美容整形手术之一,仅在2020年,美国就有超过25万例此类手术。然而,乳房植入物的安全性应得到密切研究和监测,尤其是长期安全性。
本研究旨在评估圆形微纹理欧洲硅酮(法国阿普特塞德克斯的欧洲硅酮公司)水晶凝胶乳房植入物的长期效果,该研究来自单中心、单一外科医生的经验,涉及患者报告的结局指标和翻修情况。
对2001年至2004年间接受圆形微纹理欧洲硅酮水晶凝胶乳房植入物初次隆胸手术的84例患者进行回顾性队列研究,植入物置于胸大肌下(双平面)或乳腺下。所有患者均获告知同意,获批后,发放并使用经过验证的BREAST-Q问卷来分析患者满意度。此外,分析有关翻修的客观数据,包括包膜挛缩、破裂率、疼痛和/或需要翻修手术的美学原因。
发现BREAST-Q评分较高(0至100分制变量中为67% - 100%,分类变量中66.0% - 77.3%的患者评分“非常满意”),双平面植入和乳腺下植入的患者之间无临床显著差异。总体翻修率为29.8%,两组之间也无显著差异(P = 0.317)。
本研究表明,对圆形微纹理欧洲硅酮水晶凝胶乳房植入物进行15至19年的随访后,患者满意度较高,翻修率相对较低。植入物双平面放置和乳腺下放置之间未发现临床相关的显著差异。