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European Journal of Plastic Surgery
Published in: European Journal of Plastic Surgery 5/2020

Open Access 01-10-2020 | Silicone | Original Paper

A multi-center, retrospective, preliminary observational study to assess the safety of BellaGel® after augmentation mammaplasty

Authors: Moon Seop Choi, Jae Hoon Chang, Chul Hwan Seul

Published in: European Journal of Plastic Surgery | Issue 5/2020

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Abstract

Background

BellaGel® is the only cohesive silicone gel-filled breast implant from a Korean manufacturer, and it was first developed in 2005. It was approved by the CE in 2008, thus becoming the first Asian breast implant available in the EU. We conducted this study to assess the safety of BellaGel® in patients receiving augmentation mammaplasty.

Methods

We evaluated a consecutive series of 239 patients (478 breasts) who received esthetic augmentation mammaplasty using the BellaGel® (round smooth, round textured, round nanotextured, and anatomical textured types of implant) (HansBiomed Co. Ltd., Seoul, Korea) at three clinics in Korea (JW Plastic Surgery Center, BS The Body Plastic Surgery Clinic and Grace Plastic Surgery Clinic) during a period from December 1, 2015 to January 31, 2018.

Results

A total of 239 patients with a mean age of 33.1 ± 8.5 years old were followed up during a mean period of 399.58 ± 232.71 days, where there were no cases of capsular contracture in our clinical series of the patients. Other complications include one case (0.4%) of seroma, three cases (1.3%) of hematoma, and one case (0.4%) of infection. Moreover, there were no significant differences in the cumulative incidences of complications between the four types of the BellaGel® (χ2 = 2.322, df = 3, P = 0.508). Furthermore, the cumulative Kaplan-Meier survival rate was estimated at 0.979 (95% CI 0.961–0.997).

Conclusions

Our results indicate that the BellaGel® is such a safe breast implant that surgeons might consider using it for esthetic augmentation mammaplasty.
Level of evidence: Level III, risk/prognostic study.
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Metadata
Title
A multi-center, retrospective, preliminary observational study to assess the safety of BellaGel® after augmentation mammaplasty
Authors
Moon Seop Choi
Jae Hoon Chang
Chul Hwan Seul
Publication date
01-10-2020
Publisher
Springer Berlin Heidelberg
Keywords
Silicone
Seroma
Published in
European Journal of Plastic Surgery / Issue 5/2020
Print ISSN: 0930-343X
Electronic ISSN: 1435-0130
DOI
https://doi.org/10.1007/s00238-020-01626-y

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