在2012年3月Sientra硅胶乳房植入物获得批准之后，美国食品和药物管理局要求进行一项为期10年的美国批准后研究。本文介绍了该研究的前6年结果。我们正在进行一项持续开放的前瞻性多中心研究，以评估Sientra植入物在市场后环境中接受乳房增强、重建和修复手术的患者的长期临床效果。5197名患者（10327个植入物）的招募工作于2015年3月6日完成（4046个初次增强、895个修复增强、149个初次重建和107个修复重建）。分析于第6年进行（数据库锁定：2022年1月24日）。 在所有接受植入物的队列中，调查人员报告的Baker III/IV级被膜挛缩的Kaplan-Meier风险为4.1%（韧带下放置为3.9%，腺体下放置为6.7%），再次手术的风险为11.6%，植入物摘除的风险为7.8%（更换植入物为5.9%，不更换为2.0%）。再次手术的主要原因（超过50%）是审美性（例如，样式/尺寸变更）。对于接受了植入物摘除或MRI进行破裂评估的患者，Kaplan-Meier评估的破裂风险为5.8%。总体而言，82.6%的患者对他们的植入物非常满意/高兴。未报告乳房植入物相关的巨大细胞淋巴瘤案例。 批准后研究的六年结果与十年核心研究一致，并在大型数据集中提供了进一步的证据，支持Sientra植入物的全面安全和有效性概况。 版权所有©2023作者。由Wolters Kluwer Health公司代表美国整形外科医师协会出版。保留所有权利。

After approval of Sientra silicone gel breast implants in March of 2012, the U.S. Food and Drug Administration required completion of a 10-year U.S. post-approval study. We present results from the first 6 years of this study.An ongoing, open-label, prospective, multicenter study is being conducted to evaluate the long-term clinical performance of Sientra implants in patients receiving breast augmentation, reconstruction, and revision in the post-market environment. Enrollment of 5197 patients (10,327 implants) was completed on March 6, 2015, (4046 primary augmentation, 895 revision-augmentation, 149 primary reconstruction, and 107 revision-reconstruction). Analyses were conducted at year 6 (database lock: January 24, 2022).Across all cohorts who received an implant, the Kaplan-Meier risk of investigator-reported Baker grade III/IV capsular contracture was 4.1 percent (3.9 percent with submuscular placement and 6.7 percent with subglandular placement), the risk of reoperation was 11.6 percent, and the risk of implant removal was 7.8 percent (5.9 percent with implant replacement and 2.0 percent without replacement). The primary reason (over 50 percent) for reoperation was aesthetic (e.g., style/size change). The Kaplan-Meier risk of rupture, calculated for patients who underwent explantation or MRI for rupture evaluation, was 5.8 percent. Overall, 82.6 percent of patients were highly satisfied/happy with their implant. No cases of breast implant-associated anaplastic large cell lymphoma were reported.Six-year results of the post-approval study were consistent with the 10-year core study and provide additional evidence in a large dataset supporting the comprehensive safety and effectiveness profile of the Sientra implants.Copyright © 2023 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of the American Society of Plastic Surgeons. All rights reserved.