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

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 -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.