title: Five-Year Safety and Satisfaction Study of PMMA-Collagen in the Correction of Nasolabial Folds.
abstract: BACKGROUND
  A polymethylmethacrylate-collagen filler is generally believed to give long-term benefits, but the risk of granuloma formation over time remains unclear.
  
  
  OBJECTIVE
  To determine the incidence of granuloma formation and response to treatment and assess the degree of patient satisfaction over 5 years.
  
  
  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 granuloma. Any positive responses were evaluated, and lesions suspicious for granulomas were confirmed by biopsy. Granulomas 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 granuloma developed in 1.7% of subjects. Almost all granulomas responded to treatment. At study exit, 0.9% of subjects had an unresolved granuloma. Patient satisfaction remained high throughout the duration of the study.
  
  
  CONCLUSIONS
  The incidence of granuloma formation with a polymethylmethacrylate-collagen dermal filler is low, and almost all lesions are manageable with simple therapeutic measures. Patient satisfaction remains durable over 5 years. Polymethylmethacrylate-collagen offers a well-characterized and very favorable risk/benefit profile.
authors.affiliation: *Department of Plastic Surgery, University of California, San Diego, California; †Yale University School of Medicine; ‡Dartmouth Medical School; §Brown Medical School; ‖Departments of Dermatology and Ophthalmology, University of Alabama at Birmingham, Birmingham, Alabama; ¶Department of Dermatology, New York University School of Medicine, New York, New York; #Department of Dermatology, Weill Cornell Medical College, New York, New York; **Department of Dermatology, University of Washington, Spokane, Washington; ††Suneva Medical Incorporated; ‡‡Division of Dermatology, University of California, San Diego, California.
authors.forename: Steven
authors.initials: S
authors.lastname: Cohen
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Dover
authors.forename: Gary
authors.initials: G
authors.lastname: Monheit
authors.forename: Rhoda
authors.initials: R
authors.lastname: Narins
authors.forename: Neil
authors.initials: N
authors.lastname: Sadick
authors.forename: William P
authors.initials: WP
authors.lastname: Werschler
authors.forename: Jwala
authors.initials: J
authors.lastname: Karnik
authors.forename: Stacy R
authors.initials: SR
authors.lastname: Smith
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003094:Collagen / Q000008:administration & dosage*; D003357:Cosmetic Techniques; D004338:Drug Combinations; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007271:Injections, Intradermal; D008297:Male; D008875:Middle Aged; D060052:Nasolabial Fold; D017060:Patient Satisfaction; D019904:Polymethyl Methacrylate / Q000008:administration & dosage*; D011446:Prospective Studies; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D004338:Drug Combinations; D003094:Collagen; D019904:Polymethyl Methacrylate