Bellafill (Suneva Medical) is the first FDA-approved filler to complete a five-year study demonstrating safety and effectiveness, according to a company press release.
Bellafill, formerly ArteFill, is an injectable bovine collagen dermal filler with non-absorbable polymethylmethacrylate (PMMA) beads and lidocaine. It’s approved for treatment of moderate to severe nasolabial folds and acne scars in patients older than 21 years, according to the FDA.
The not-yet-published five-year post-approval study for nasolabial folds is the largest and longest prospective dermal filler study to date, according Suneva.
Related: ArteFill changes name to Bellafill
Researchers looked at the use of Bellafill to treat nasolabial folds in 1,008 patients at 23 U.S. study centers. Researchers reported an 87% retention rate at five years, with 83 percent of patients saying they were satisfied or very satisfied with the results. Among the patients studied, 11.7% experienced treatment-related adverse events (TRAEs), the most common being injection-site lumpiness and redness. Granuloma incidence was 1.7%, which according to San Diego plastic surgeon and study author Steven Cohen, M.D., is an important finding.
Expert Opinion on Bellefill
“The strong supporting evidence of Bellafill’s safety profile supplies data that allow physicians to use the filler with confidence, dispelling misconceptions about the product’s long-term safety profile including the very low rate of granulomas, which can occur with any dermal filler," says Dr. Cohen, who is a clinical professor of plastic surgery at the University of California, San Diego.
Paul Nassif, M.D., a facial plastic and reconstructive surgeon who practices in Beverly Hills, Calif., tells Cosmetic Surgery Times: “This study is impressive and important, as it demonstrates the long-term efficacy and safety of Bellafill. I have known about Bellafill for a while, but I still don’t use it with my patients. I have always been conservative when it comes to permanent or non-reversible fillers (like Bellafill), but I will continue to evaluate Bellafill and its role in my practice — especially in light of this new research.”
