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

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® (χ 2 = 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.

An Ultrasound-Assisted Approach to an Early Detection of Complications of an Implant-Based Augmentation Mammaplasty using the BellaGel® SmoothFine: Preliminary 3-year Clinical Experience

“…From this context, the BellaGel® (HansBiomed Co. Ltd., Seoul, Korea) is known as a silicone gel-filled breast implant that best fits to Korean women [13]. Its short-term safety has been well described in the literature, which is in agreement with 4-and 6-year interim results of a 10-year prospective cohort study [13][14][15][16]. The BellaGel® SmoothFine is the BellaGel® implant with a microtextured surface; it is equipped with softness as well as a refined, smooth surface with a roughness of 5.96 µm, which is a different feature from traditional smooth surface, according to the International Organization for Standardization (ISO) 14607 Annex H Test for surface characteristics (Figure 1).…”

“…Of these, CC occurred at an incidence of 8.8%. This is noteworthy because manufacturer-sponsored retrospective studies have shown incidences of 0.0% (0/239), 0.6% (1/78) and 1.6% (10/621) in patients receiving the BellaGel® implants including the BellaGel® SmoothFine [14,19,20]. Interestingly, another manufacturer-sponsored experimental study compared the vulnerability to CC based on surface properties between the BellaGel® implants, including the BellaGel® SmoothFine, and the Motiva Ergonomix TM SilkSurface (Establishment Labs Holdings Inc., Alajuela, Costa Rica), thus drawing conclusions that the BellaGel® SmoothFine was the least vulnerable to CC of the sample devices [18].…”

Association of the BellaGel® Breast Implant Scandal with the Poly Implant Prothèse Fraud: A Review of Literatures

“…Moreover, they are covered with five layers except for anatomical devices covered with six layers [25]. The BellaGel ® was first developed in 2005 and then approved by the CE in 2008; it has become commercially available in 30 countries worldwide [26]. Previous studies have described the efficacy and safety of the BellaGel ® [24][25][26][27][28][29].…”

<strong>Clinical Experience with the Fifth-Generation of a Breast Implant with a Smooth, Fine Surface from a Korean Manufacturer in Asian Women</strong>

“…The BellaGel  implants, including the BellaGel  SmoothFine, have been exported to 30 countries worldwide since they were first developed in 2005 [9]. It is noteworthy that their efficacy and safety have been established through evidence-based studies [8][9][10][11][12]. As recently described, it was found to be more excellent than its competitors in Korea [11].…”