High-Resolution Ultrasound-Assisted Assessment of Preliminary Short-term Safety Outcomes of an Implant-Based Augmentation Mammaplasty Using a Bioengineered, Cell-Friendly, Smooth-Surface Device in Korean Females.

BACKGROUND: The Motiva Ergonomix Round SilkSurface (Establishment Labs Holdings Inc., Alajuela, Costa Rica) is one of the representative brands of the fifth generation of a silicone gel-filled breast implant with a microtextured surface. OBJECTIVES: In this study, the authors describe preliminary short-term safety outcomes of an implant-based augmentation mammaplasty using the Motiva Ergonomix Round SilkSurface in Korean females. METHODS: The authors performed a retrospective analysis of medical records in a total of 69 females (n = 69) receiving an implant-based augmentation mammaplasty using the Motiva Ergonomix Round SilkSurface between September 26, 2017, and December 31, 2020. The authors analyzed incidences of postoperative complications. RESULTS: A total of 6 cases (8.7%) of postoperative complications occurred; these include 2 cases (2.9%) of early seroma, 1 case (1.4%) of capsular contracture, 2 cases (2.9%) of alterations in the shape, and 1 case (1.4%) of foreign body sensation. Time-to-events were estimated at 266.81 ± 273.17 days. CONCLUSIONS: The authors describe our preliminary short-term safety outcomes of an implant-based augmentation mammaplasty using the Motiva Ergonomix Round SilkSurface in Korean females. But this deserves further large-scale studies with long periods of follow-up.

Short-term treatment outcomes and safety of two representative brands of the fifth-generation silicone gel-filled breast implants in Korea.

It is allegedly reported that the BellaGel® SmoothFine (HansBiomed Co. Ltd., Seoul, Korea) and Motiva ErgonomixTM (Establishment Labs Holdings Inc., Alajuela, Costa Rica) are representative brands of a microtextured breast implant in Korea. We compared short-term safety outcomes between them. We evaluated the patients who received breast augmentation using the BellaGel® SmoothFine (n = 264) or the Motiva Ergonomix™ (n = 76) for aesthetic purposes and those with available medical records. They were followed up during a mean period of 122.11 ± 95.37 (4-477) and 126.80 ± 116.29 (13-534) days in the corresponding order. Early seroma occurred at an incidence of 1.89 and 5.26% following breast augmentation using the BellaGel® SmoothFine and the Motiva ErgonomixTM, respectively. This difference reached statistical significance (p < 0.05). Of note, CC occurred at an incidence of 2.27 and 0.00% in the corresponding order. Cumulative incidences of postoperative complications depending on the type of breast implants showed no significant difference; statistical significance was analyzed using the log-rank test (χ2 = 1.71, df = 1, p = 0.19). Cumulative survival of the breast implant is shown in Table 3; the Motiva Ergonomix™ showed a longer survival as compared with the BellaGel® SmoothFine (130.13 ± 13.70 vs. 120.45 ± 5.76 days). In conclusion, we describe short-term treatment outcomes and safety of an implant-based breast augmentation using two representative brands of the fifth-generation silicone gel-filled breast implants in Korean women.

Short-term Safety of Augmentation Mammaplasty Using the BellaGel Implants in Korean Women.

Asian women are stereotypically characterized by a slim body, smaller breasts and areolae, and larger nipples when compared with White women. They would therefore be vulnerable to displacement of a breast implant if they receive larger implants. They are also prone to hypertrophic and prolonged hyperemic scars. Surgeons should therefore be aware of Asian women's breast anatomy, healing tendency, and preferences. We conducted this multicenter, retrospective study to assess the short-term safety of the BellaGel implants in Korean women. METHODS: We evaluated a total of 637 women (n = 637; 1,274 breasts) for incidences of postoperative complications and the cumulative Kaplan-Meier complication-free survival. RESULTS: Overall, there were 12 cases (1.9%) of postoperative complications; these include 6 cases (0.9%) of hematoma, 2 cases (0.3%) of infection, and 4 cases (0.6%) of seroma. Moreover, there was no significant difference in the cumulative complication-free survival at 120 weeks between the 4 types of the BellaGel implants (χ2 = 2.289, P = 0.513). CONCLUSION: In conclusion, we describe the short-term safety of augmentation mammaplasty using the BellaGel implants in Korean women. But further prospective, large-scale, multicenter studies with a long period of follow-up are warranted to establish our results.