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

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. PMID: 30888239 [PubMed - as supplied by publisher]
Source: Journal of Plastic Surgery and Hand Surgery - Category: Surgery Tags: J Plast Surg Hand Surg Source Type: research