Duteille Franck, Rouif Michel, Laurent Sophie, Cannon Máirín
Centre des Brûlés, Immeuble Jean Monnet, CHU, Nantes, France; Cabinet Medical, Tours, France; Eurosilicone S.A.S., ZI de la Peyrolière, BP 68, Apt Cedex, France; and GC Aesthetics, Dublin, Ireland.
Plast Reconstr Surg Glob Open. 2014 May 7;2(4):e138. doi: 10.1097/GOX.0000000000000082. eCollection 2014 Apr.
Multicenter prospective studies assessing the safety and efficacy of silicone gel breast implants are relatively rare. Eurosilicone S.A.S. present their safety and efficacy data herein for the largest European silicone gel breast implant study published to date.
One thousand and ten of Eurosilicone's textured cohesive Cristalline Paragel range of mammary implants was implanted in women undergoing augmentation and reconstructive surgery at 17 centers throughout France. Physical examinations and complications were recorded by physicians at 3 months and annually thereafter until 10 years postimplantation. Descriptive statistics were used and key complications were analyzed using the Kaplan-Meier analysis method.
Two ruptures were observed within 5 years postimplantation, one of which was subject to mechanical trauma during reoperation and the other was identified during routine screening. Capsular contracture, one of the most common complications associated with breast implants, was reported in 6.6% implants across all indications through 5 years. The Kaplan-Meier risk of capsular contracture (Baker III/IV) was 10.7% (95% confidence interval, 7.2-14.2%) and 17.2% (95% confidence interval, 5.4-29%) in the primary augmentation and primary reconstruction patient cohorts, respectively. Implant removal (explantation/exchange) was 8.5% and 16.5% for primary augmentation and primary reconstruction cohorts, respectively. Rates of local complications including infection and seroma were low with risk rates of 0.6% and 0.2% by subject.
Eurosilicone S.A.S. prospective study involving 1010 Eurosilicone silicone gel breast implants in both round and shaped profiles demonstrated a low rupture rate and an excellent safety profile through 5 years.
评估硅胶乳房植入物安全性和有效性的多中心前瞻性研究相对较少。欧洲硅胶公司（Eurosilicone S.A.S.）在此展示了迄今为止发表的最大规模欧洲硅胶乳房植入物研究的安全性和有效性数据。
欧洲硅胶公司的1010个有纹理的凝聚性Cristalline Paragel系列乳房植入物被植入法国各地17个中心接受隆乳和重建手术的女性体内。医生在术后3个月进行体格检查并记录并发症情况，此后每年记录一次，直至植入后10年。采用描述性统计方法，并使用Kaplan-Meier分析方法分析关键并发症。
在植入后5年内观察到2例破裂，其中1例在再次手术时受到机械创伤，另一例在常规筛查时被发现。包膜挛缩是与乳房植入物相关的最常见并发症之一，在所有适应症的植入物中，5年内报告的发生率为6.6%。在初次隆乳和初次重建患者队列中，包膜挛缩（Baker III/IV级）的Kaplan-Meier风险分别为10.7%（95%置信区间，7.2 - 14.2%）和17.2%（95%置信区间，5.4 - 29%）。初次隆乳和初次重建队列的植入物取出率（取出/更换）分别为8.5%和16.5%。包括感染和血清肿在内的局部并发症发生率较低，按个体计算风险率分别为0.6%和0.2%。
欧洲硅胶公司的前瞻性研究涉及1010个圆形和异形的欧洲硅胶公司硅胶乳房植入物，结果显示5年内破裂率低且安全性良好。
