Short Kimberly K, Wixtrom Roger N, Estes Megan M, Leopold John, Canady John W
The Gillian Institute, Indianapolis, Ind.
LSCI, Springfield, Va.
Plast Reconstr Surg Glob Open. 2021 Mar 26;9(3):e3402. doi: 10.1097/GOX.0000000000003402. eCollection 2021 Mar.
The approval of Mentor MemoryGel Breast Implants in November 2006 was conditional on conducting a 10-year study designed to collect long-term experience in US women with MemoryGel Breast Implants, known as the MemoryGel Post-Approval Study.
This prospective, observational 10-year follow-up study used a current cohort design that began in 2007, which included both MemoryGel Breast Implant participants and concurrent saline controls to assess rheumatologic and neurologic signs and symptoms. The protocol was amended in 2015, which limited the scope of further data collection for the study to only secondary procedure/re-operation data for MemoryGel participants.
Primary augmentation (n = 6743), revision augmentation (n = 2071), primary reconstruction (n = 1763), and revision reconstruction (n = 557) participants were enrolled in the Re-operation Phase Safety Set. Kaplan-Meier-estimated 10-year cumulative incidence of re-operation and explantation on a participant-level were 10.5% and 4.2% (primary augmentation), 14.1% and 7.7% (revision augmentation), 20.8% and 12.8% (primary reconstruction), and 25.0% and 16.6% (revision reconstruction).
The Re-operation Phase of the post-approval study addressed the Kaplan-Meier implant removal and re-operation rates over time, and provided the reasons for re-operation over time. Overall, no significant new hazards, increased risk, or unexpected adverse events were identified in the MemoryGel Post-Approval Study Re-operation Phase Safety Set.
2006年11月曼托MemoryGel乳房植入物获批是有条件的，条件是开展一项为期10年的研究，旨在收集美国使用MemoryGel乳房植入物女性的长期经验，即MemoryGel批准后研究。
这项前瞻性观察性10年随访研究采用始于2007年的当前队列设计，纳入了MemoryGel乳房植入物参与者和同期盐水对照组，以评估风湿和神经体征及症状。该方案于2015年修订，将该研究进一步数据收集范围限制为仅MemoryGel参与者的二次手术/再次手术数据。
初次隆乳（n = 6743）、修复隆乳（n = 2071）、初次重建（n = 1763）和修复重建（n = 557）参与者被纳入再次手术阶段安全集。在参与者层面，卡普兰-迈耶估计的10年再次手术和取出植入物的累积发生率分别为10.5%和4.2%（初次隆乳）、14.1%和7.7%（修复隆乳）、20.8%和12.8%（初次重建）以及25.0%和16.6%（修复重建）。
批准后研究的再次手术阶段阐述了随时间推移的卡普兰-迈耶植入物取出率和再次手术率，并给出了随时间推移再次手术的原因。总体而言，在MemoryGel批准后研究再次手术阶段安全集中未发现重大新风险、风险增加或意外不良事件。
