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

Abstract

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.