Five-Year Safety and Satisfaction Study of XXXX -Collagen in the Correction of Nasolabial Folds.

@entity1 @entity4625 @entity738
BACKGROUND: A polymethylmethacrylate-collagen filler is generally believed to give long-term benefits, but the risk of @entity738 formation over time remains unclear. OBJECTIVE: To determine the incidence of @entity738 formation and response to treatment and assess the degree of @entity1 satisfaction over 5 years. MATERIALS AND METHODS: Adults seeking correction of nasolabial folds underwent up to 3 injection sessions over 2 months. Subjects were then queried regularly for the development of signs and symptoms of a @entity738 . Any positive responses were evaluated, and lesions suspicious for @entity738 were confirmed by biopsy. @entity738 were treated at the discretion of the investigator. Subjects also completed regular satisfaction questionnaires. RESULTS: A total of 1,008 subjects were enrolled and 871 completed the full 5 years of the study. A biopsy-confirmed @entity738 developed in 1.7% of subjects. Almost all @entity738 responded to treatment. At study exit, 0.9% of subjects had an unresolved @entity738 . @entity1 satisfaction remained high throughout the duration of the study. CONCLUSION: The incidence of @entity738 formation with a polymethylmethacrylate-collagen dermal filler is low, and almost all lesions are manageable with simple therapeutic measures. @entity1 satisfaction remains durable over 5 years. @entity4625 -collagen offers a well-characterized and very favorable risk/benefit profile.
