Current status of an implant-based augmentation mammaplasty in Korean women: Implications for risk management and social sustainability of breast implant industry in the context of the first Korean case of a medical device fraud.

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.