title: Five-year safety and efficacy of a novel polymethylmethacrylate aesthetic soft tissue filler for the correction of nasolabial folds.
abstract: BACKGROUND
  A novel soft tissue filler composed of polymethylmethacrylate (PMMA) microspheres suspended in a collagen gel matrix containing 0.3% lidocaine (ArteFill, Artes Medical, Inc.) was recently approved by the Food and Drug Administration for the correction of nasolabial folds. A randomized, multicenter, controlled pivotal trial performed in the United States established the safety and efficacy of this medical device throughout a 12-month study period.
  
  
  OBJECTIVE
  The objective was to substantiate the long-term 5-year safety and efficacy of this novel soft tissue PMMA filler.
  
  
  METHODS
  Attempts were made to contact all subjects treated with the PMMA filler that were enrolled in the original pivotal study. Safety was assessed by standard adverse event reporting methods. Efficacy was determined using a validated six-point facial fold assessment photometric grading scale using blinded observers' assessment of standardized photographs.
  
  
  RESULTS
  Subjects (n=119) demonstrated significant improvement in nasolabial folds comparing baseline (before any treatment) to 5 years after their last treatment (p<.001). Notably, subjects also demonstrated continued improvement between 6 months after their last treatment and Year 5 (p=.002). No serious unanticipated device-related adverse events were reported.
  
  
  CONCLUSIONS
  This PMMA filler is the first soft tissue filler to demonstrate continued improvement and persistence of correction over a 5-year period posttreatment.
authors: FACESplus Aesthetic Facility, La Jolla, California, USA.
authors: Steven R
authors: SR
authors: Cohen
authors: Carl F
authors: CF
authors: Berner
authors: Mariano
authors: M
authors: Busso
authors: Paul
authors: P
authors: Clopton
authors: Douglas
authors: D
authors: Hamilton
authors: James J
authors: JJ
authors: Romano
authors: Peter P
authors: PP
authors: Rullan
authors: Millard P
authors: MP
authors: Thaler
authors: Zeena
authors: Z
authors: Ubogy
authors: Thomas R
authors: TR
authors: Vecchione
mesh_terms: D003094:Collagen / Q000008:administration & dosage*; D003357:Cosmetic Techniques; D005145:Face; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007267:Injections; D008297:Male; D008863:Microspheres; D008875:Middle Aged; D019904:Polymethyl Methacrylate / Q000008:administration & dosage*; D016032:Randomized Controlled Trials as Topic; D018709:Statistics, Nonparametric; D016896:Treatment Outcome
chemical_list: C516180:ArteFill; D003094:Collagen; D019904:Polymethyl Methacrylate