Duteille Franck, Perrot Pierre, Bacheley Marie-Hélène, Bell Erin, Stewart Sharon
Centre des Brûlés, Immeuble Jean Monnet, Centre Hospitalier Universitaire, Nantes, France.
Eurosilicone, Apt Cedex, France.
Aesthet Surg J Open Forum. 2019 Apr 27;1(2):ojz012. doi: 10.1093/asjof/ojz012. eCollection 2019 Jun.
Although silicone breast implants have been available for over 60 years, their safety and efficacy continue to be assessed via long-term clinical and vigilance studies. Complications often associated with breast implant surgery include but are not limited to capsular contracture and rupture.
The authors investigate and evaluate the safety and performance of Eurosilicone's (Eurosilicone S.A.S, Apt Cedex, France) Cristalline Paragel breast implants at least 10 years postimplantation.
Nine hundred and ninety-five of Eurosilicone's textured mammary implants were implanted in 526 women undergoing primary (423 patients) and revision surgery (103 patients) at 17 centers throughout France. Complications were recorded at 3 months and annually thereafter for 10 years. Descriptive statistics were used and the Kaplan-Meier method was utilized to analyze key complications.
Seventy-four women (98 implants) experienced capsular contracture across all cohorts. The Kaplan-Meier 10-year cumulative risk of capsular contracture (Baker Grade III/IV) per implant was 11.5% in the primary augmentation cohort and 25.2% in the primary reconstruction cohort. Sixteen implant ruptures were observed by surgeon examination giving a Kaplan-Meier risk of 3.8% per patient and 3.5% per implant. Surgical re-intervention (explantation/exchange) was reported 80 times resulting in a Kaplan-Meier cumulative risk of 13.3% and 31.6% for primary augmentation and primary reconstruction, respectively, per patient. Local complication rates including infection and seroma were low with risk rates of 0.6% and 0.2% by subject.
This multicenter clinical study demonstrates the long-term safety and efficacy profile through 10 years for Eurosilicone round and anatomical silicone gel breast implants.
尽管硅胶乳房植入物已经应用了60多年，但仍需通过长期临床和监测研究来评估其安全性和有效性。乳房植入手术常见的并发症包括但不限于包膜挛缩和破裂。
作者对法国欧罗硅胶公司（Eurosilicone S.A.S，阿普特塞德克斯，法国）的Cristalline Paragel乳房植入物植入至少10年后的安全性和性能进行调查和评估。
995枚欧罗硅胶公司的带纹理乳房植入物被植入法国各地17个中心的526名接受初次手术（423例患者）和修复手术（103例患者）的女性体内。术后3个月记录并发症情况，此后每年记录一次，持续10年。采用描述性统计方法，并运用Kaplan-Meier法分析关键并发症。
所有队列中有74名女性（98枚植入物）发生包膜挛缩。初次隆乳队列中每枚植入物发生包膜挛缩（贝克III/IV级）的Kaplan-Meier 10年累积风险为11.5%，初次重建队列中为25.2%。通过外科医生检查观察到16例植入物破裂，每位患者的Kaplan-Meier风险为3.8%，每枚植入物为3.5%。报告了80次手术再次干预（取出/更换），初次隆乳和初次重建每位患者的Kaplan-Meier累积风险分别为13.3%和31.6%。包括感染和血清肿在内的局部并发症发生率较低，按受试者计算风险率分别为0.6%和0.2%。
这项多中心临床研究证明了欧罗硅胶圆形和解剖型硅胶凝胶乳房植入物10年的长期安全性和有效性。
