Nashville, Tenn.; Westlake Village and Santa Barbara, Calif.; and Tampa, Fla. From the Plastic Surgery Center of Nashville; Westlake Cosmetic Surgery Center; Cosmetic and Reconstructive Surgery Center; and Sientra Inc.
Plast Reconstr Surg. 2014 Jul;134(1 Suppl):38S-46S. doi: 10.1097/PRS.0000000000000346.
The Sientra portfolio of silicone gel breast implants was approved by the Food and Drug Administration on March 9, 2012, and included the first approved shaped implants in the United States. The 5-year results from Sientra's Core Gel and Continued Access Study and the results of a single surgeon are presented.
This analysis used the data of 640 shaped implants in 321 primary augmentation patients implanted by 16 study surgeons through 5 years. The Kaplan-Meier method was used to analyze safety endpoints. In addition, analysis is presented for a single surgeon's results of 213 shaped implants in 108 postapproval patients through up to 16 months of follow-up (9-month mean) using a separate frequency analysis.
The overall risk of rupture for primary augmentation patients through 5 years was 0.4%, the risk of infection was 1.4%, and the risk of capsular contracture (Baker grade III/IV) was 3.9%. Reported surgeon satisfaction was 100%, and patient satisfaction remained high. In the separate single-surgeon analysis, after 16 months, 4 of the 108 patients experienced a complication (3.7%) and 3 underwent a reoperation (2.8%). Complications included infection, ptosis (0.9%, each), and capsular contracture (1.9%).
The results of Sientra's large clinical study and the postapproval data from a single surgeon demonstrate the safety and effectiveness of Sientra's shaped implants. The review of the data and author's experience illustrate the ease of incorporating shaped implants into any surgical practice.
Sientra 公司的硅胶凝胶乳房植入物于 2012 年 3 月 9 日获得美国食品和药物管理局批准，其中包括美国首批获准的成型植入物。本文呈现了 Sientra 公司的 Core Gel 和 Continued Access 研究的 5 年结果以及一位外科医生的单组研究结果。
本分析纳入了 16 位研究医生为 321 名初次隆乳患者共植入 640 枚成型假体的临床数据，随访时间为 5 年。采用 Kaplan-Meier 方法分析安全性终点。此外，还对一位外科医生在批准后 16 个月（9 个月平均随访时间）内使用 213 枚成型假体的结果进行了单独的频率分析。
5 年内，初次隆乳患者的总体破裂风险为 0.4%，感染风险为 1.4%，包膜挛缩（Baker 分级 III/IV 级）风险为 3.9%。报告的外科医生满意度为 100%，患者满意度仍然很高。在单独的单组外科医生分析中，16 个月后，108 名患者中有 4 名（3.7%）出现并发症，3 名（2.8%）需要再次手术。并发症包括感染、下垂（0.9%，各 1 例）和包膜挛缩（1.9%）。
Sientra 公司的大型临床研究结果和单外科医生的批准后数据表明，Sientra 公司的成型植入物具有安全性和有效性。对数据的回顾和作者的经验表明，将成型植入物纳入任何外科手术实践都非常容易。
