Aesthet Surg J. 2021 May 18;41(6):NP329-NP335. doi: 10.1093/asj/sjaa388.
Results from the MemoryGel Breast Implants Core Clinical Study suggest these devices are safe and effective at 10 years after implantation. Although clinical trials are essential for measuring the safety and effectiveness of a device, real-world evidence can supplement clinical trials by providing information on outcomes observed in diverse clinical settings for a more heterogeneous population, without fixed treatment patterns, and without continuous patient monitoring, such that follow-up is more representative of normal clinical practice.
The aim of this study was to measure real-world outcomes, including safety and effectiveness, in patients who underwent primary breast augmentation with smooth MemoryGel implants.
This was a case series looking at patients, age 22 years and older, who underwent primary breast augmentation at a single site between December 2006 and December 2016 and who had a minimum of 2 years of follow-up. Descriptive statistics were used to summarize baseline characteristics and outcomes. Kaplan-Meier models were used to estimate safety outcomes for capsular contracture (Baker grade III/IV), infection, and rupture.
A total of 50/777 (6.4%) patients reported a complication, with an average time to complication of 3.9 years (range, 19 days-11.8 years) postprocedure. Kaplan-Meier estimates of the 10-year cumulative incidence of capsular contracture (Baker grade III/IV), infection, and rupture were 4.7%, 0.1%, and 1.6%, respectively.
Analyses of a large population from a single site provide further support for the long-term safety and effectiveness of MemoryGel breast implants in a primary augmentation cohort.
MemoryGel 乳房植入物核心临床研究的结果表明，这些装置在植入 10 年后是安全且有效的。虽然临床试验对于测量设备的安全性和有效性至关重要，但真实世界的数据可以通过提供在不同临床环境中观察到的结果信息来补充临床试验，这些结果信息适用于更异质的人群，不存在固定的治疗模式，也无需持续的患者监测，从而使随访更能代表正常的临床实践。
本研究旨在测量接受光滑 MemoryGel 植入物进行原发性乳房增大的患者的真实世界结局，包括安全性和有效性。
这是一项病例系列研究，观察了 2006 年 12 月至 2016 年 12 月期间在单一机构接受原发性乳房增大且随访时间至少 2 年的年龄 22 岁及以上的患者。使用描述性统计数据总结基线特征和结局。Kaplan-Meier 模型用于估计包膜挛缩（Baker 分级 III/IV）、感染和破裂的安全性结局。
共有 50/777（6.4%）例患者报告发生了并发症，术后并发症的平均时间为 3.9 年（范围为 19 天-11.8 年）。Kaplan-Meier 估计 10 年累积包膜挛缩（Baker 分级 III/IV）、感染和破裂的发生率分别为 4.7%、0.1%和 1.6%。
对来自单一机构的大量人群进行的分析进一步支持了 MemoryGel 乳房植入物在原发性增大队列中的长期安全性和有效性。
