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

Abstract

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

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Correspondence to Yu Kwan Song.

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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

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Keywords

  • Breast
  • Breast implants
  • Kaplan–Meier estimate
  • Magnetic resonance imaging
  • Biofilms
  • Seroma