Kim Robert
Department of Medical and Pharmaceutical Affairs, Doctor CONSULT, Seoul, Korea.
Medicine (Baltimore). 2025 Sep 5;104(36):e44092. doi: 10.1097/MD.0000000000044092.
Stakeholders in the breast implant industry in Korea have recently experienced a crisis from breast implant-associated anaplastic large cell lymphoma and the first Korean case of a medical device fraud. We compared the short-term safety between the microtextured devices that are commercially available after the occurrence of breast implant crisis in Korea. The current study was conducted in a cohort of Korean women who had received an implant-based augmentation mammaplasty for aesthetic purposes between November 14, 2020 and October 13, 2022. We considered risk factors of complications in analyzing the safety of devices for the current study. A total of 801 Korean women (n = 801) were finally assessed. Incidences of capsular contracture were 1.79% (3/168), 3.64% (21/577), 8.11% (3/37), and 10.53% (2/19) in the patients receiving Motiva Ergonomix, Sebbin Sublimity, Sebbin Integrity, and Eurosilicone Round Collection, respectively. These differences reached statistical significance (P < .05). There were 2 women with rupture after receiving Sebbin Sublimity, although there were no cases of rupture in association with other brands of breast implants. Overall capsular contracture-free survival was estimated at 681.470 ± 8.314 (95% confidence interval [CI] 665.174-697.766) days. By breast implants, it was 708.899 ± 8.595 (95% CI 692.053-725.745), 599.327 ± 6.607 (95% CI 586.378-612.277), 584.941 ± 22.965 (95% CI 539.931-629.952), and 572.492 ± 37.374 (95% CI 499.240-645.745) days in the patients receiving Motiva Ergonomix, Sebbin Sublimity, Sebbin Integrity, and Eurosilicone Round Collection, respectively, in the increasing order. In conclusion, our results indicate that Motiva Ergonomix Round SilkSurface is currently a relatively safer device as compared with others in the context of the first Korean case of a medical device fraud. The breast implant industry in Korea should be aware of the importance of the social sustainability in manufacturing a device.
韩国乳房植入物行业的利益相关者最近经历了一场因乳房植入物相关间变性大细胞淋巴瘤以及韩国首例医疗器械欺诈案引发的危机。我们比较了韩国乳房植入物危机发生后市面上可获得的微纹理装置之间的短期安全性。本研究在一组韩国女性队列中进行，这些女性在2020年11月14日至2022年10月13日期间因美容目的接受了基于植入物的隆乳术。在分析当前研究中装置的安全性时，我们考虑了并发症的风险因素。最终共评估了801名韩国女性（n = 801）。接受Motiva Ergonomix、Sebbin Sublimity、Sebbin Integrity和Eurosilicone Round Collection的患者中，包膜挛缩的发生率分别为1.79%（3/168）、3.64%（21/577）、8.11%（3/37）和10.53%（2/19）。这些差异具有统计学意义（P <.05）。接受Sebbin Sublimity的患者中有2名出现破裂，而其他品牌的乳房植入物未出现破裂病例。总体无包膜挛缩生存率估计为681.470 ± 8.314（95%置信区间[CI] 665.174 - 697.766）天。按乳房植入物品牌划分，接受Motiva Ergonomix、Sebbin Sublimity、Sebbin Integrity和Eurosilicone Round Collection的患者的无包膜挛缩生存率分别为708.899 ± 8.595（95% CI 692.053 - 725.745）天、599.327 ± 6.607（95% CI 586.378 - 612.277）天、584.941 ± 22.965（95% CI 539.931 - 629.952）天和572.492 ± 37.374（95% CI 499.240 - 645.745）天，呈递增顺序。总之，我们的结果表明，在韩国首例医疗器械欺诈案的背景下，与其他产品相比，Motiva Ergonomix Round SilkSurface目前是一种相对更安全的装置。韩国的乳房植入物行业应意识到在制造装置时社会可持续性的重要性。
