Bellafill Safety Profile Keeps Long-Lasting Filler Going Strong
By Jeffrey Frentzen, Executive Editor
A recent study confirms dermal filler Bellafill® (Suneva Medical, San Diego, Calif.) has set a new standard for establishing the long-term safety of dermal filler treatments. According to the company’s recently released 10-year post market surveillance, from 2007 to December 2016 around 600,000 syringes have been sold with a noteworthy 0.11% of adverse events reported.
In addition to the product’s remarkable safety profile, its longevity, reportedly up to five years, is key, stated Steven F. Weiner, M.D., a facial plastic surgeon in Santa Rosa Beach, Fla., referring to the results of the landmark, 2015 post-approval clinical study that confirmed the enduring safety and effectiveness of Bellafill through five years.
“There is no other safety protocol like Bellafill’s,” he said. “There is no other filler that has been studied for as long as Bellafill has.”
Bellafill consists of microscopic homogenous PMMA (polymethylmethacrylate) beads in 3.5% bovine collagen suspension, mixed with 0.3% Lidocaine. It is injected into the dermis where the bovine collagen degrades within one to three months and is replaced by the body’s own collagen.
The PMMA microspheres act as a scaffold to stimulate production of endogenous collagen. As noted by Rich Castellano, a cosmetic surgeon in Tampa, Fla., “Bellafill can be used in a variety of patients young and old. It can be used as a deep injection for volume as well as superficially for treating fine line creases.”
Practitioners and patients should understand while Bellafill is a truly permanent facial filler a series of treatment sessions will be needed to achieve optimal results, according to Gerald Pierone, Jr., M.D., a facial injector in Vero Beach, Fla.
“As the bovine collagen is reabsorbed, the PMMA microspheres are surrounded by macrophages and multi-nucleated giant cells along with bands of naturally produced collagen. However this volume is less than the bovine collagen that was injected, so there is an overall reduction in volume as compared with the immediate result. Subsequent injection sessions require fewer Bellafill syringes to achieve correction since they build upon the previous permanent PMMA filler base.
As reported by Dr. Weiner, “The typical Bellafill patient has already received multiple filler injections, may be experiencing filler fatigue, and wants something longer lasting. Also, older men will ask for something that’s going to last. Then there is the whole spectrum of patients with acne scars.”
Bellafill is uniquely the only filler on the market that is FDA approved for the effective correction of moderate to severe, atrophic, distensible facial acne scars on the cheek in people over 21 years old.
“This represents a huge opportunity for a population that hasn’t really had much success with other types of therapies,” noted Dr. Weiner. “Those patients are the happiest of my clients.”
According to Dr. Pierone, Bellafill should only be injected by highly experienced practitioners who have mastered facial injection techniques. “The product itself is very smooth and when properly injected any complications should be quite rare,” he said.
Dr. Castellano sees long-lasting fillers like Bellafill as the future of aesthetics, adding, “I believe the demand for Bellafill is only going to go up.”