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.
In this study, we describe 4-year interim results of the safety of augmentation mammaplasty using the Motiva Ergonomix™ Round SilkSurface in Korean women.
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.
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).
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.
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Conflict of interest
The authors have nothing to declare in relation to the current work.
All procedures described herein were performed in accordance with the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards.
Written informed consent was waived due to the retrospective nature of the current study.
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Hong, P., Kim, S.S., Jeong, C. et al. Four-Year Interim Results of the Safety of Augmentation Mammaplasty Using the Motiva Ergonomix™ Round SilkSurface: A Multicenter, Retrospective Study. Aesth Plast Surg (2021). https://doi.org/10.1007/s00266-021-02152-3
- Breast implants
- Kaplan–Meier estimate
- Magnetic resonance imaging