A Preliminary Retrospective Study to Assess the Short-Term Safety of Traditional Smooth or Microtextured Silicone Gel-Filled Breast Implants in Korea.

Background and objectives: We conducted this preliminary retrospective study to assess the short-term safety of silicone gel-filled breast implants (SGBIs) that are commercially available in Korean women. Materials and methods :The current retrospective, observational study was conducted in a total of 2612 patients (n = 2612) who underwent augmentation mammaplasty using breast implants at our hospitals between 1 January 2017 and 31 August 2021. Results: Overall, there were a total of 248 cases (9.49%) of postoperative complications; these include 112 cases of early seroma, 52 cases of shape deformation, 32 cases of CC, 12 cases of early hematoma, 12 cases of rupture, 12 cases of infection, 12 cases of stretch deformities with skin excess and 4 cases of rippling. Overall complication-free survival of the breast implant was estimated at 1564.32 ± 75.52 days (95% CI 1416.39-1712.32). Then, the Motiva Ergonomix™ SilkSurface showed the longest survival (1528.00 ± 157.92 days [95% CI 1218.48-1837.56]), followed by the BellaGel® SmoothFine (1458.4 ± 65.76 days [95% CI 1329.56-1587.28]), the Sebbin® Sublimity (1322.00 ± 51.20 days [95% CI 1221.64-1422.32]), the BellaGel® Smooth (1138.72 ± 161.28 days [95% CI 822.6-1454.84), the Mentor® MemoryGel™ Xtra (698.4 ± 52.64 days [95% CI 595.28-801.52]) and the Natrelle® INSPIRA™ (380.00 ± 170.88 days [95% CI 45.04-714.96]) in the decreasing order. On subgroup analysis, both the Motiva ErgonomixTM and Mentor® MemoryGel™ Xtra showed no postoperative complications. However, the BellaGel® SmoothFine, Sebbin® Sublimity and BellaGel® Smooth showed incidences of 8.87%, 4.84% and 1.61%, respectively. A subgroup analysis also showed differences in incidences of postoperative complications between microtextured and smooth breast implants (15.18% vs. 16.67%). Conclusions: In conclusion, our results indicate that diverse types of an SGBI are commercially available and their safety profile varies according to the manufacturer. Plastic surgeons should consider the safety profile of each device in selecting the optimal types of the device for Korean women who are in need of an implant-based augmentation mammaplasty. However, this warrants a single-surgeon, single-center study with long periods of follow-up.

Four-Year Interim Results of the Safety of Augmentation Mammaplasty Using the Motiva Ergonomix™ Round SilkSurface: A Multicenter, Retrospective Study.

BACKGROUND: 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. OBJECTIVES: In this study, we describe 4-year interim results of the safety of augmentation mammaplasty using the Motiva Ergonomix™ Round SilkSurface in Korean women. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to Table of Contents or the online Instructions to Authors www.springer.com/00266 .