An open label, uncontrolled, prospective study has established Bellafill® as the only dermal filler that is safe and effective through 5 years. The primary objective of the study was to determine the incidence of granuloma formation and the incidence of adverse events at each follow-up period.
The results speak for themselves:
- By patient, over the 5 year study period, there was a low 11.7% rate of treatment-related adverse events (majority were mild and most resolved).
- Granulomas occurred infrequently as demonstrated by a 1.7% granuloma rate (17 patients reported granulomas). The majority were mild to moderate, all either resolved or improved.
- Bellafill® demonstrated a low rate of treatment-related adverse events over 5 years.
- 1% granulomas resolved.
- <1% granulomas unresolved.4
- The safety of Bellafill® has been established in the largest and longest prospective dermal filler study ever conducted, with 23 study centers and 1,008 patients over 5 years.
- The effectiveness of Bellafill® was established with an 87% retention rate and 83% of patients were satisfied to very satisfied at the end of 5 years.
- The 5 Year Post Approval Study is the largest and longest prospective dermal filler study ever conducted.