Protocol for the Post-approval Study of ArteFill® for Correction of Nasolabial Folds

Inclusion Criteria:

• Subject is male or non-pregnant female 18 years of age or older.
• Subject has provided written and verbal informed consent.
• Subject is willing to comply with study instructions and return to the clinic for required visits.
• Subject is willing to withhold additional aesthetic implant therapies to the NLF [e.g., other soft tissue fillers: Restylane, Silicone, Radiesse, Sculptra) or implants: gortex, silastic, thread lift, etc.] for the duration of the study.

Exclusion Criteria:

• Subject has any skin pathology or condition that could interfere with the evaluation of the treatment areas.
• Subject has a history of systemic granulomatous diseases active or inactive (e.g.Sarcoid, Wegeners, TB, etc.) or connective tissue diseases (.e.g., lupus,dermatomyositis, etc.).
• Subject is immuno-compromised in the opinion of the investigator because of disease or medical therapy (e.g., HIV, use of chemotherapy, etc.)

• Subject has been treated with any of the following in their NLF in the time intervals specified prior to the start of their participation in the study:

  • Bovine collagen - 6 months
  • Porcine or human collagen - one year
  • Hyaluronic acid - one year
  • Hydroxylapatite - one year
  • Autologous fat - at any time
  • Polymethylmethacrylate or other acrylates - at any time
  • Polyacrylamide - at any time
  • Polyethylene oxide - at any time
  • Polylactic acid - at any time
  • Liquid silicone - at any time
  • Other permanent implant material (FDA approved or not) - at any time
• Subject has had the placement of any surgical implants in the NL folds region(e.g., Gortex, Silastic implants, thread lifts, etc.) at any time.
• Subject has a history of multiple severe allergies or allergies manifested by anaphylaxis.
• Subject has a history of allergy to lidocaine.
• Subject has a history of allergies to any bovine collagen products, including but not limited to injectable collagen, collagen implants, hemostatic sponges, and collagen-based sutures.
• The subject has known hypersensitivity or previous allergic reaction to any of the components of the study devices not previously mentioned.
• Subject is undergoing or planning to undergo desensitization injections to meat products.
• Subject has any condition which, in the Investigator's opinion, would make it unsafe for the subject to participate in this research study.
• Subject is unable to communicate or cooperate with the Investigator due to language problems, poor mental development, or impaired cerebral function.
• Subject may be unreliable for the study including subjects who engage in excessive alcohol intake or drug abuse, or subjects who are unable to return for scheduled follow-up visits.