ArteFill permanent injectable for soft tissue augmentation: II. Indications and applications

Area of Science:

• Dermatology
• Plastic Surgery
• Biomaterials

Background:

• Patients seek cosmetic procedures with enduring results.
• ArteFill, approved by the FDA in 2006, is a permanent injectable filler for nasolabial folds.
• It comprises polymethylmethacrylate (PMMA) microspheres within a bovine collagen suspension.

Purpose of the Study:

• To evaluate the long-term efficacy and safety of ArteFill for cosmetic enhancement.
• To assess patient and physician satisfaction with ArteFill treatments.

Main Methods:

• A 5-year follow-up study of U.S. clinical trial patients.
• Long-term follow-up data from European Artecoll (precursor to ArteFill) patients.
• Analysis of complication rates, focusing on granuloma formation.

Main Results:

• Sustained wrinkle improvement observed from 6 months to 5 years in U.S. patients.
• Successful wrinkle correction lasting up to 15 years reported in European patients.
• Serious complications like granuloma formation were not reported due to optimized PMMA microsphere size and quantity (<1% <20 microm).
• Patient and physician satisfaction rates exceeded 90%.

Conclusions:

• ArteFill provides durable, long-lasting wrinkle correction.
• The product has evolved to meet modern safety standards comparable to hyaluronic acid fillers.
• High satisfaction rates and a low incidence of serious complications support ArteFill's efficacy and safety for cosmetic applications.