Department of Radiology, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, Korea.
Liting Plastic Surgery Clinic, Seoul, Korea.
Aesthetic Plast Surg. 2021 Jun;45(3):895-903. doi: 10.1007/s00266-021-02152-3. Epub 2021 Mar 1.
The Motiva Ergonomix™ Round SilkSurface (Establishment Labs Holdings Inc., Alajuela, Costa Rica) is the fifth generation of a silicone gel-filled breast implant that is commercially available in Korea.
In this study, we describe 4-year interim results of the safety of augmentation mammaplasty using the Motiva Ergonomix™ Round SilkSurface in Korean women.
In the current multicenter, retrospective study, we performed a retrospective review of medical records of a total of 1314 patients who received augmentation mammaplasty using the Motiva Ergonomix™ Round SilkSurface at our hospitals between September 1, 2016, and August 31, 2020. For safety assessment, we analyzed incidences of postoperative complications and Kaplan-Meier complication-free survival of the patients.
We included a total of 873 patients (1746 breasts, mean age = 32.18 ± 6.88 years) in the current study. There were a total of 111 cases (12.70%) of postoperative complications; these include 24 cases (2.70%) of early seroma, 18 cases (2.10%) of hematoma, 18 cases (2.10%) of capsular contracture, 17 cases (1.95%) of dissatisfaction with shape, 16 cases (1.83%) of dissatisfaction with size, 9 cases (1.03%) of asymmetry, 6 cases (0.70%) of infection and 3 cases (0.34%) of rippling. Moreover, time-to-events were estimated at 918.34 ± 36.22 days (95% CI 845.44-988.52).
Here, we describe 4-year interim results of the safety of augmentation mammaplasty using the Motiva Ergonomix™ Round SilkSurface in Korean women in a non-manufacturer-sponsored study. But further large-scale, prospective, multicenter studies with a long period of follow-up are warranted to establish our results.
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Motiva Ergonomix™Round SilkSurface（Establishment Labs Holdings Inc.，哥斯达黎加阿拉胡埃拉）是第五代商用硅胶填充乳房植入物，在韩国有售。
本研究旨在描述韩国女性接受 Motiva Ergonomix™Round SilkSurface 隆乳术的 4 年中期安全性结果。
在本次多中心回顾性研究中，我们对 2016 年 9 月 1 日至 2020 年 8 月 31 日期间在我院接受 Motiva Ergonomix™Round SilkSurface 隆乳术的 1314 例患者的病历进行了回顾性分析。为了评估安全性，我们分析了患者术后并发症的发生率和 Kaplan-Meier 无并发症生存情况。
本研究共纳入 873 例患者（1746 只乳房，平均年龄 32.18±6.88 岁）。共有 111 例（12.70%）发生术后并发症，包括 24 例（2.70%）早期血清肿、18 例（2.10%）血肿、18 例（2.10%）包膜挛缩、17 例（1.95%）对形状不满意、16 例（1.83%）对大小不满意、9 例（1.03%）不对称、6 例（0.70%）感染和 3 例（0.34%）波纹。此外，事件时间估计为 918.34±36.22 天（95%CI 845.44-988.52）。
本研究在非制造商赞助的研究中描述了韩国女性接受 Motiva Ergonomix™Round SilkSurface 隆乳术的 4 年中期安全性结果。但需要进一步开展大规模、前瞻性、多中心、长期随访的研究来验证我们的结果。
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