BACKGROUND:Cross-linked polyacrylamide hydrogel, a nonabsorbable soft-tissue filler, has given promising results regarding efficacy and safety at 24 months of follow-up, but because adverse reactions have been described years after injection of some other fillers, a prolonged follow-up was required. OBJECTIVE: To examine the safety and efficacy of the hydrogel in facial contouring after 36 to 48 months (mean 40 months). METHODS: In this prospective multicenter trial, the esthetic results and safety of the treatments were assessed at 36 to 48 months, and the results were compared with those seen previously. RESULTS:Eighty-one patients participated. The investigator rated esthetic results as very good or good in 99% of cases, and 98% of patients rated esthetic results as very satisfactory or satisfactory. Two of nine reported adverse events were possibly related to hydrogel treatment. One was initial infection after a touch-up, and one was continuous itching 1 year after injection. CONCLUSION: The polyacrylamide hydrogel filler was still well tolerated after 36 to 48 months with no long-term unexpected adverse events and no loss of filler effect.
RCT Entities:
BACKGROUND: Cross-linked polyacrylamide hydrogel, a nonabsorbable soft-tissue filler, has given promising results regarding efficacy and safety at 24 months of follow-up, but because adverse reactions have been described years after injection of some other fillers, a prolonged follow-up was required. OBJECTIVE: To examine the safety and efficacy of the hydrogel in facial contouring after 36 to 48 months (mean 40 months). METHODS: In this prospective multicenter trial, the esthetic results and safety of the treatments were assessed at 36 to 48 months, and the results were compared with those seen previously. RESULTS: Eighty-one patients participated. The investigator rated esthetic results as very good or good in 99% of cases, and 98% of patients rated esthetic results as very satisfactory or satisfactory. Two of nine reported adverse events were possibly related to hydrogel treatment. One was initial infection after a touch-up, and one was continuous itching 1 year after injection. CONCLUSION: The polyacrylamide hydrogel filler was still well tolerated after 36 to 48 months with no long-term unexpected adverse events and no loss of filler effect.