BellaGel breast implant: 4-year results of a prospective cohort study

Abstract

The demand for high-quality silicone breast implants is rising. This was the first clinical study on implantation of Asian company-made silicone breast implants into Asian women. The authors report 4-year study data for BellaGel implants. This study is an ongoing 10-year study with 103 subjects undergoing augmentation or primary reconstruction with BellaGel implants. To assess effectiveness, rupture and capsular contracture rates were measured and Kaplan–Meier analysis was performed. Paired t-test was used to determine significant changes in breast dimensions. Safety assessment included evaluation of all adverse reactions. Average follow-up period was 5.9 years. Implant rupture and capsular contracture rate through 4 years were 0 percent and 2.3 percent, respectively. Capsular contracture rate was lower in the augmentation group (0.8%) than in the reconstruction group (5.6%). Among the adverse events, procedural pain was the only complication considered device-related, apart from capsular contracture. These 4-year data from the ongoing implant study support the effectiveness and safety of BellaGel implants.

Keywords:

• Breast implant
• breast augmentation
• breast reconstruction
• capsular contracture

Disclosure statement

Chan-Yeong Heo is a consultant for Hansbiomed and received funding for this study. Sa Ik Bang received funding for this study. For the remaining authors, none were declared. HansBiomed provided data on shell properties, the manufacturing process and tensile strength of BellaGel implant shell.

Additional information

Funding

This study was financially supported by HansBiomed.