Prospective multicenter study for evaluation of safety, efficacy, and esthetic results of cross-linked polyacrylamide hydrogel in 81 patients.

[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.