From private practice.
the Division of Plastic Surgery, Department of Surgery, University of Louisville.
Plast Reconstr Surg. 2024 Jul 1;154(1):44e-56e. doi: 10.1097/PRS.0000000000010953. Epub 2023 Aug 11.
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. postapproval study. The authors 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 undergoing breast augmentation, reconstruction, and revision in the postmarket 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% (3.9% with submuscular placement and 6.75%with subglandular placement), the risk of reoperation was 11.6%, and the risk of implant removal was 7.8% (5.9% with implant replacement and 2.0% without replacement). The primary reason (>50%) for reoperation was aesthetic (eg, style/size change). The Kaplan-Meier risk of rupture, calculated for patients who underwent explantation or MRI for rupture evaluation, was 5.8%. Overall, 82.6% 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 postapproval study were consistent with the 10-year core study and provide additional evidence in a large data set supporting the comprehensive safety and effectiveness profile of the Sientra implants.
2012 年 3 月 Sientra 硅胶乳房植入物获得批准后，美国食品和药物管理局要求完成一项为期 10 年的美国上市后研究。作者呈现了该研究的前 6 年的结果。
一项正在进行的、开放性、前瞻性、多中心研究正在进行，以评估 Sientra 植入物在上市后环境中接受乳房隆乳术、重建术和翻修术的患者的长期临床性能。2015 年 3 月 6 日完成了 5197 例患者（10327 个植入物）的入组（4046 例初次隆乳术、895 例隆乳术翻修术、149 例初次重建术和 107 例重建术翻修术）。分析于第 6 年（数据库锁定：2022 年 1 月 24 日）进行。
在所有接受植入物的队列中，研究者报告的贝克 III/IV 级包膜挛缩的 Kaplan-Meier 风险为 4.1%（肌下放置为 3.9%，胸大肌下放置为 6.75%），再次手术的风险为 11.6%，而植入物取出的风险为 7.8%（5.9%为植入物更换，2.0%为无更换）。再次手术的主要原因（>50%）为美观（例如，风格/大小改变）。对于接受取出或 MRI 以评估破裂的患者，计算得出的破裂的 Kaplan-Meier 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。没有报告与乳房植入物相关的间变性大细胞淋巴瘤病例。
上市后研究的 6 年结果与 10 年核心研究一致，并在一个大型数据集提供了额外的证据，支持 Sientra 植入物的全面安全性和有效性概况。
