Suneva Medical announced that Bellafill demonstrated safety and effectiveness in a five-year post-approval study for nasolabial folds.
The study of Bellafill was the largest and longest prospective dermal filler study every conducted, and included high patient satisfaction, according to a press release. The five-year, post-FDA approval study included 1,008 patients enrolled in 23 study centers in the United States, with long-term safety the primary endpoint and effectiveness a secondary objective, according to the release.
There was an 87% retention rate at five years, with 83% of patients reporting “satisfied” or “very satisfied” with treatment outcome at the end of the study, the release stated.
No serious adverse events (AEs) were reported, according to the release. Treatment-related AEs had an incidence of 11.7%, with the majority being mild in severity and resolved by the end of the study, according to the release. Treatment-related AEs included lumpiness at injection site and redness. Granuloma incidence was infrequent at 1.7%, the release reported.
“In a world where the demand for injectables is rapidly increasing, this … further substantiates the long-term safety and effectiveness of Bellafill treatment,” Steven Cohen, MD, FACS, a clinical professor at the University of California, San Diego, who has studied Bellafill for more than 15 years, said in the release. “The strong supporting evidence of Bellafill’s safety profile … [dispels] misconceptions about the product’s long-term safety profile, including the very low rate of granulomas, which can occur with any dermal filler.”
Bellafill is approved by the FDA for correction of nasolabial folds and moderate to severe, atrophic, distensible, facial acne scars on the cheeks of adults over that age of 21 years, according to the release.