From the Pacific Center for Plastic Surgery, University of California, Irvine, and Mission Plasticos.
Imagine Plastic Surgery Center.
Plast Reconstr Surg. 2023 Sep 1;152(3):424e-432e. doi: 10.1097/PRS.0000000000010312. Epub 2023 Feb 24.
The Ideal Implant structured breast implant uses different technology than unstructured saline or silicone gel implants, making it a third type of implant. U.S. Food and Drug Administration (FDA) and Health Canada granted approval in November of 2014. This saline-filled implant has an internal structure consisting of a series of nested shells that support the upper pole when upright and control movement of the saline to provide a natural feel. Because women can look in the mirror to know their implants are intact, they have peace of mind. In contrast, most women are concerned about silicone gel implant ruptures, which are silent and require FDA-recommended magnetic resonance imaging or ultrasound scans for detection.
This U.S. trial enrolled 502 women: 399 for primary and 103 for revision augmentation. Investigators were 45 American Board of Plastic Surgery-certified plastic surgeons at 35 sites. Of the 502 women enrolled, 426 (84.9%) completed 10-year follow-up visits, a higher percentage than all other FDA breast implant trials.
Through 10 years of follow-up, surgeon satisfaction was 94.8% for primary and 87.4% for revision augmentation; and patient satisfaction was 92.7% for primary and 82.3% for revision augmentation. Cumulative Kaplan-Meier risk rates for two major adverse events were lower than in the silicone gel implant trials: Baker class III and IV capsular contracture was 6.6% for primary and 11.5% for revision augmentation; and rupture/deflation was 3.7% for primary and 4.7% for revision augmentation.
Ten-year results from 426 women show the Ideal Implant has high patient and surgeon satisfaction, a low rate of capsular contracture, and a low rate of rupture/deflation.
CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.
理想植入物结构型乳房植入物采用的技术与非结构型盐水或硅胶凝胶植入物不同，是第三种类型的植入物。美国食品和药物管理局（FDA）和加拿大卫生部于 2014 年 11 月批准了该产品。这种充满盐水的植入物具有内部结构，由一系列嵌套的外壳组成，这些外壳在直立时支撑上极，并控制盐水的流动，以提供自然的感觉。由于女性可以照镜子知道自己的植入物完好无损，因此她们感到安心。相比之下，大多数女性都担心硅胶凝胶植入物破裂，这种破裂是无声的，需要进行 FDA 推荐的磁共振成像或超声扫描才能发现。
这项美国试验纳入了 502 名女性：399 名初次隆胸，103 名乳房修复术。研究者是 35 个地点的 45 名美国整形外科学会认证的整形医生。在这 502 名入组的女性中，有 426 名（84.9%）完成了 10 年随访，这一比例高于所有其他 FDA 乳房植入物试验。
在 10 年的随访中，初次隆胸的手术医生满意度为 94.8%，乳房修复术为 87.4%；初次隆胸的患者满意度为 92.7%，乳房修复术为 82.3%。两种主要不良事件的累积 Kaplan-Meier 风险率低于硅胶凝胶植入物试验：初次隆胸的贝克 III 级和 IV 级包膜挛缩为 6.6%，乳房修复术为 11.5%；初次隆胸的破裂/瘪塌为 3.7%，乳房修复术为 4.7%。
来自 426 名女性的 10 年结果显示，理想植入物具有较高的患者和手术医生满意度、较低的包膜挛缩率和破裂/瘪塌率。
临床问题/证据水平：治疗性，IV 级。
