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

Abstract

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 studywith long periods of follow-up.

Efficacy of a 4-Week Nurse-Led Exercise Rehabilitation Program in Improving the Quality of Life in Women Receiving a Post-Mastectomy Reconstruction Using the Motiva ErgonomixTM Round SilkSurface

“…She complained of severe depressive symptoms, had a handful of hair fall every day, presented with insomnia, and was inclined to commit suicide [140]. The safety of the Motiva Ergonomix TM Round SilkSurface was confirmed in a cohort of Korean women, as previously described [85,86,141]. It was previously reported that the Motiva Ergonomix TM Round SilkSurface might be a device of choice for Korean women who faced a crisis from the first Korean case of a medical device fraud [86].…”

Feasibility of Imaging Modalities Combined with a Silicone Gel-Filled Breast Implant in Korean Women

“…Indeed, the Motiva Ergonomix TM Round SilkSurface might be the device of choice for Korean women who have been faced with the BIA-ALCL crisis and the first Korean case of medical device fraud [ 24 , 70 ]. The cost of the Motiva Ergonomix TM Round SilkSurface is the highest, although it triggered a boom in microtextured devices [ 71 ]. As described above, 15,570 and 9732 devices were sold by Mentor Worldwide LLC.…”

“…and Establishment Labs Holdings Inc., respectively, between January and June of 2021 [ 23 ]. Considering that their costs are USD 5070.01 and 8450.02 in corresponding order, it can be inferred that the total revenue of their sales reached USD 78,940,055.7 and 82,235,594.64 [ 71 ]. This indicates that the Motiva Ergonomix TM Round SilkSurface is the most popular brand of SGBI in Korea.…”

“…To date, evidence-based efforts have been made to define the safety of the Motiva Ergonomix TM Round SilkSurface in Korea. Previous studies have shown that patients receiving the Motiva Ergonomix TM Round SilkSurface presented with postoperative complications at rates of 6.58–12.82% [ 21 , 24 , 25 , 53 , 71 , 73 ]. This is in agreement with our results showing that there were a total of 11 cases (12.6%) of postoperative complications (five cases (5.7%) of early seroma, two cases (2.3%) of infection, two cases (2.3%) of rippling, one case (1.1%) of hematoma and one case (1.1%) of CC).…”

A Comparison of Smooth and Microtextured Breast Implants in Breast Augmentation: A Retrospective Study

“…The study mainly compared various silicone gel implant products, but there was no comparison or analysis of smooth and microtextured silicone gel implants and no statistical significance was found between groups. 23 Tanner reported that the incidence of capsular contracture was low as a result of analyzing the clinical results of 214 patients who used microtextured silicone gel implants in breast cosmetic surgery. However, that study also did not compare smooth and microtextured silicone gel implants.…”