From Parkcrest Plastic Surgery and Clinical Faculty, Division of Plastic Surgery, Department of Surgery, Washington University; private practice and Clinical Faculty, Division of Plastic Surgery, Department of Surgery, University of Louisville and University of Kentucky; LSCI; and Mentor Worldwide, LLC.
Plast Reconstr Surg. 2021 Mar 1;147(3):556-566. doi: 10.1097/PRS.0000000000007635.
BACKGROUND: Mentor MemoryGel Breast Implants were approved by the U.S. Food and Drug Administration in November of 2006. Patients in the Core clinical study supporting this approval were followed for 10 years. METHODS: This prospective, multicenter, clinical study included primary augmentation, revision augmentation, primary reconstruction, and revision reconstruction patients implanted with smooth or Siltex Texture MemoryGel Implants. Incidence, severity, and method of resolution for all postoperative complications were assessed on per-patient and per-implant bases. The primary effectiveness endpoints were overall mean change in chest circumference and bra cup size following the implantation procedure. RESULTS: Primary augmentation (n = 552), revision augmentation (n = 145), primary reconstruction (n = 251), and revision reconstruction (n = 60) patients were enrolled in the study. Kaplan-Meier estimated 10-year cumulative incidence rates for key complications at the subject level for Baker grade III/IV capsular contracture were as follows: primary augmentation, 12.1 percent; revision augmentation, 24.4 percent; primary reconstruction, 20.5 percent; and revision reconstruction, 36.9 percent. For infection, rates were as follows: primary augmentation, 1.6 percent; revision augmentation, 1.4 percent; primary reconstruction, 6.2 percent; and revision reconstruction, 0 percent. For explantation with or without replacement, rates were as follows: primary augmentation, 11.6 percent; revision augmentation, 24.1 percent; primary reconstruction, 33.4 percent; and revision reconstruction; 37.8 percent. For rupture, rates were as follows: primary augmentation, 24.2 percent; revision augmentation, 23.7 percent; primary reconstruction, 32.7 percent; and revision reconstruction, 38.7 percent. For any reoperation, rates were as follows: primary augmentation, 25.5 percent; revision augmentation, 43.6 percent; primary reconstruction, 49.0 percent; and revision reconstruction, 50.7 percent. CONCLUSION: The results of this study demonstrate that MemoryGel Implants are safe and effective for use in women undergoing breast augmentation or reconstruction. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.
背景：Mentor MemoryGel 乳房植入物于 2006 年 11 月获得美国食品和药物管理局批准。支持该批准的核心临床研究中的患者随访了 10 年。
方法：这项前瞻性、多中心、临床研究纳入了接受光滑或 Siltex 纹理 MemoryGel 植入物进行原发性隆胸、修复性隆胸、原发性重建和修复性重建的患者。在患者和植入物基础上评估所有术后并发症的发生率、严重程度和解决方法。主要有效性终点是植入手术后胸部周长和胸罩罩杯大小的总体平均变化。
结果：该研究纳入了原发性隆胸（n = 552）、修复性隆胸（n = 145）、原发性重建（n = 251）和修复性重建（n = 60）患者。基于患者水平的 Kaplan-Meier 估计 10 年关键并发症的累积发生率为 Baker 分级 III/IV 包膜挛缩：原发性隆胸为 12.1%；修复性隆胸为 24.4%；原发性重建为 20.5%；修复性重建为 36.9%。对于感染，发生率如下：原发性隆胸为 1.6%；修复性隆胸为 1.4%；原发性重建为 6.2%；修复性重建为 0%。对于取出和/或更换植入物，发生率如下：原发性隆胸为 11.6%；修复性隆胸为 24.1%；原发性重建为 33.4%；修复性重建为 37.8%。对于破裂，发生率如下：原发性隆胸为 24.2%；修复性隆胸为 23.7%；原发性重建为 32.7%；修复性重建为 38.7%。对于任何再手术，发生率如下：原发性隆胸为 25.5%；修复性隆胸为 43.6%；原发性重建为 49.0%；修复性重建为 50.7%。
结论：这项研究的结果表明，MemoryGel 植入物在接受隆胸或重建的女性中使用是安全有效的。
临床问题/证据水平：治疗性，IV 级。
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