来自美国针对Sientra公司经美国食品药品监督管理局批准的圆形和塑形、含高强度凝聚性硅胶凝胶乳房植入物的临床试验的八年随访数据。
Eight-year follow-up data from the U.S. clinical trial for Sientra's FDA-approved round and shaped implants with high-strength cohesive silicone gel.
作者信息
Stevens W Grant, Harrington Jennifer, Alizadeh Kaveh, Broadway David, Zeidler Kamakshi, Godinez Tess B
机构信息
Dr Stevens is a Clinical Professor of Surgery in the Division of Plastic Surgery at the University of Southern California School of Medicine and Director of the University of Southern California-Marina del Rey Aesthetic Surgery Fellowship Program, Los Angeles. Dr Harrington is a plastic surgeon in private practice in Plymouth, MN. Dr Alizadeh is a plastic surgeon in private practice in Great Neck, NY. Dr Broadway is a plastic surgeon in private practice in Lone Tree, CO. Dr Zeidler is a plastic surgeon in private practice in Campbell, CA. Ms Godinez is the Director of Clinical Operations at Sientra, Inc., Santa Barbara, CA.
出版信息
Aesthet Surg J. 2015 May;35 Suppl 1:S3-10. doi: 10.1093/asj/sjv020.
BACKGROUND
On March 9, 2012, the Food and Drug Administration (FDA) approved Sientra's premarket approval application for its portfolio of silicone gel breast implants based on their review of Sientra's 3-year study data from the largest pivotal silicone gel breast implant study to date. This included the first approval of shaped breast implants in the United States.
OBJECTIVES
The authors provide an update to the 8-year safety and effectiveness of the Sientra High-Strength silicone gel breast implants.
METHODS
The Sientra Core study is an ongoing 10 year open-label, prospective, multi-center clinical study, which includes 1788 patients implanted with 3506 Sientra implants across four indications (Primary Augmentation, Revision Augmentation, Primary Reconstruction, and Revision Reconstruction). For the safety analysis, the incidence of post-operative complications, including all breast implant-related adverse effects (eg, infection, asymmetry), was estimated based on Kaplan-Meier risk rates. The effectiveness analyses include surgeon and patient satisfaction and changes in bra/cup size.
RESULTS
Through 8 years, the overall risk of rupture was 4.6%, the risk of capsular contracture was 11.8% (rates were lower when using True Texture™), and the risk of reoperation was 28.3%. Out of the 580 reoperations in 456 patients, over half of all reoperations were due to cosmetic reasons (n = 299). The most common reasons for reoperation were capsular contracture (19.0%), style and/or size change (18.4%), and asymmetry (8.8%). Patient satisfaction remains high through 8 years, with 87% indicating that their breast implants make them feel more feminine than prior to enrollment.
CONCLUSIONS
Safety data from the FDA Core study continues to support a comprehensive safety and effectiveness profile of Sientra's portfolio of round and shaped implants through 8 years.
LEVEL OF EVIDENCE
3 Therapeutic.
背景
2012年3月9日，美国食品药品监督管理局（FDA）基于对Sientra公司迄今为止最大规模的硅胶乳房植入物关键研究的3年研究数据的审查，批准了Sientra公司硅胶乳房植入物系列的上市前批准申请。这包括美国首次批准的成型乳房植入物。
目的
作者提供了Sientra高强度硅胶乳房植入物8年安全性和有效性的最新情况。
方法
Sientra核心研究是一项正在进行的为期10年的开放标签、前瞻性、多中心临床研究，包括1788例患者植入3506枚Sientra植入物，涉及四种适应症（初次隆乳、修复性隆乳、初次重建和修复性重建）。对于安全性分析，根据Kaplan-Meier风险率估计术后并发症的发生率，包括所有与乳房植入物相关的不良反应（如感染、不对称）。有效性分析包括外科医生和患者满意度以及胸罩/罩杯尺寸的变化。
结果
8年来，破裂的总体风险为4.6%，包膜挛缩的风险为11.8%（使用True Texture™时发生率较低），再次手术的风险为28.3%。在456例患者的580次再次手术中，超过一半的再次手术是出于美容原因（n = 299）。再次手术最常见的原因是包膜挛缩（19.0%）、款式和/或尺寸改变（18.4%）以及不对称（8.8%）。8年来患者满意度一直很高，87%的患者表示他们的乳房植入物让他们感觉比入组前更有女人味。
结论
FDA核心研究的安全性数据继续支持Sientra圆形和成型植入物系列在8年内的全面安全性和有效性概况。
证据水平
3级治疗性。
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