FDA Approves Bellafill, the first filler to last 5 years
We are aware of several injectable fillers that bring decent results but only for a rather short period of time, usually for up to 1 year (most usually fillers that include hyaluronic acid last for 6 to 9 months). The good news are coming from FDA.. yesterday FDA approved Bellafill, a filler that is supposed to last for 5 years. Bellafill treats smile lines and acne scars, but still is not tested in cheeks filling. Also its not suitable for as a filler for the lips.
How did Bellafill get this 5-year approval? The filler was tested during an extended study. It was injected in 1008 patients’ smile lines (aka nasolobial folds) in 23 centers accross USA. It was found that 5 years after injection patients had a 87% retention rate. This was enough to give Bellafill its FDA Approval. This filler is based on another filler called Artefill.. a reformulation of that filler gave birth to Bellafill.. its formula includes polymethylmethacrylate (PMMA), collagen as well as 0.3 percent lidocaine.
As for the side effects of Bellafill, they do exist and have to do redness, tenderness, lumpiness and granulomas. Lump is a symptom that dissappears later while granuloma (an inflamed lump) needs to be treated.. Dr. Steven R. Cohen, the leader of the study says “granulomas are inflamed lumps or nodules and can be diagnosed under a microscope. They are treated with steroids and/or a strong chemical agent called 5-FU”.
Summing up the results of the study Dr. Cohen says that 83% of the participants were satisfied to very satisfied with Bellafill, even if suffering from lumps and adds “patients in the study reported better results at five years than at one year. There is an ongoing but steady state of augmentation as the body responds to the PMMA spheres by laying down new collagen. These results should be reassuring to patients who want a permanent filler.”
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