Department of Plastic Surgery, Loma Linda University School of Medicine, California, USA.
Aesthet Surg J. 2012 Aug;32(6):709-17. doi: 10.1177/1090820X12452423. Epub 2012 Jun 29.
BACKGROUND: The Natrelle Style 410 shaped, form-stable silicone gel implant (Allergan, Inc; Irvine, California) has been the subject of a pivotal study that supports potential US Food and Drug Administration approval of the device. The 3-year results of this study were reported previously. OBJECTIVES: The authors update the safety and effectiveness findings for the Natrelle Style 410 implants through 6 years of study. METHODS: This prospective, nonrandomized, multicenter study included 941 patients (492 primary augmentations, 156 revision-augmentations, 225 primary reconstructions, and 68 revision-reconstructions). Since the original 3-year report, follow-up visits have been conducted annually. Kaplan-Meier risk rates were calculated for local complications, reoperations, and explantations. One-third of the subjects were enrolled in the magnetic resonance imaging (MRI) cohort and underwent biannual MRI rupture screening. Effectiveness was measured by subject satisfaction on a 5-point scale. RESULTS: As expected after breast implantation, capsular contracture (CC) was one of the most common complications, with 6-year risk rates of 4.6% for augmentation, 6.9% for revision-augmentation, 10.7% for reconstruction, and 18.3% for revision-reconstruction. The rates for CC among augmentations and revision-augmentations were significantly lower with the Natrelle 410 implants than with other standard gel implants. The rupture rate (confirmed plus suspected) across all cohorts was 6.4% by subject and 3.8% by implant. The most common reasons for reoperation were style or size change (augmentation), implant malposition (revision-augmentation), scarring (reconstruction), and CC (revision-reconstruction). The satisfaction rate exceeded 80% in all cohorts. CONCLUSIONS: These fifth-generation, form-stable implants represent another option to achieve desired aesthetic outcomes with minimal complications.
背景:Natrelle Style 410 形状、形态稳定的硅胶凝胶植入物(Allergan,Inc;加利福尼亚州欧文市)一直是一项关键研究的主题,该研究支持该设备获得美国食品和药物管理局的潜在批准。此前报道了该研究的 3 年结果。
目的:作者通过 6 年的研究更新了 Natrelle Style 410 植入物的安全性和有效性发现。
方法:这项前瞻性、非随机、多中心研究纳入了 941 名患者(492 例初次隆胸、156 例隆胸修复、225 例乳房重建、68 例乳房重建修复)。自原始 3 年报告以来,每年进行一次随访。计算局部并发症、再次手术和取出的 Kaplan-Meier 风险率。三分之一的受试者被纳入磁共振成像(MRI)队列,并进行每两年一次的 MRI 破裂筛查。通过受试者满意度 5 分制来衡量有效性。
结果:与乳房植入后预期的情况一样,包膜挛缩(CC)是最常见的并发症之一,6 年的风险率为隆胸 4.6%、隆胸修复 6.9%、乳房重建 10.7%和乳房重建修复 18.3%。Natrelle 410 植入物的隆胸和隆胸修复的 CC 发生率明显低于其他标准凝胶植入物。所有队列中,通过受试者和植入物分别为 6.4%和 3.8%确定的破裂率(确诊加疑似)。再次手术的最常见原因是样式或大小改变(隆胸)、植入物位置不当(隆胸修复)、疤痕(重建)和 CC(重建修复)。所有队列的满意度均超过 80%。
结论:这些第五代形态稳定的植入物为实现最小并发症的理想美容效果提供了另一种选择。
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