Saturno Maurizio, Stewart Sharon, Bell Erin, Esposito Emanuela
Plastic Surgery Unit, St Carlo Hospital, Potenza, Italy.
GC Aesthetics, Glasgow, UK.
Aesthet Surg J Open Forum. 2019 Jun 20;1(3):ojz018. doi: 10.1093/asjof/ojz018. eCollection 2019 Sep.
BACKGROUND: Silicone breast implants have been widely used for breast augmentation and reconstruction. During this time, silicone breast implants have undergone several modifications to improve their safety, quality, and clinical performance. Complications such as reoperation, capsular contracture, and rupture are risks often associated with breast implants. OBJECTIVES: The authors conducted a retrospective study to analyze and report complication rates associated with Eurosilicone's (Eurosilicone S.A.S, Apt, Cedex, France) silicone gel-filled breast implants over a period of 5 years. METHODS: In this retrospective clinical study, 2151 women who underwent either breast augmentation or breast reconstruction with Eurosilicone breast implants were diagnosed. Data on early and late complications including implant removal (explantation/exchange), capsular contracture, and rupture were collected using questionnaires, completed by 39 surgeons across Italy. RESULTS: Of the 2151, only 60 patients (2.78%) required implant removal. Twenty-five patients experienced capsular contracture (Baker Grade III/IV), giving an actual rate of 1.2%. The actual rate of implant rupture confirmed by breast magnetic resonance images was 0.18% (4 implants). Six patients (0.27%) were diagnosed with breast cancer following breast augmentation, and local complications including hematoma (1 patient) and seroma (2 patients) were experienced. CONCLUSIONS: This retrospective clinical study involving Eurosilicone's round and anatomical textured silicone gel-filled mammary implants demonstrates an excellent safety profile through 5 years. UNLABELLED: .
背景:硅胶乳房植入物已广泛用于隆胸和乳房重建。在此期间,硅胶乳房植入物经历了几次改进,以提高其安全性、质量和临床性能。诸如再次手术、包膜挛缩和破裂等并发症是乳房植入物常伴随的风险。 目的:作者进行了一项回顾性研究,以分析和报告欧洲硅胶公司(Eurosilicone S.A.S,法国阿普特市)的硅胶凝胶填充乳房植入物在5年期间的并发症发生率。 方法:在这项回顾性临床研究中,诊断出2151名接受欧洲硅胶乳房植入物隆胸或乳房重建的女性。通过意大利39位外科医生填写的问卷,收集了包括植入物取出(取出/更换)、包膜挛缩和破裂在内的早期和晚期并发症数据。 结果:在2151名患者中,只有60名患者(2.78%)需要取出植入物。25名患者发生包膜挛缩(贝克III/IV级),实际发生率为1.2%。经乳房磁共振成像证实的植入物破裂实际发生率为0.18%(4个植入物)。6名患者(0.27%)在隆胸后被诊断出患有乳腺癌,并出现了包括血肿(1例)和血清肿(2例)在内的局部并发症。 结论:这项涉及欧洲硅胶公司圆形和解剖型纹理硅胶凝胶填充乳房植入物的回顾性临床研究表明,其在5年期间具有出色的安全性。 未标注:.
Aesthet Surg J Open Forum. 2019-6-20
Aesthet Surg J Open Forum. 2019-4-27
Aesthet Surg J. 2018-2-17
Plast Reconstr Surg Glob Open. 2014-5-7
Plast Reconstr Surg. 2003-8
Plast Reconstr Surg. 2017-12
Aesthet Surg J. 2018-2-17
Aesthet Surg J. 2012-11
Aesthet Surg J. 2012-6-29