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The FDA has the strictest approval criteria in the world. Safety and efficacy are the two lodestars. Ellanse has gotten mixed reviews, based possibly on injector technique. Given that non-physicians make up an enormous segment of the injector population, the regulators must have concern. The manufacturers, on the other hand, are constantly bringing and marketing new products to public attention. There are so many fillers currently available that I would not fall into the hype.
FDA approval is a long, complex, expensive and time consuming process.I've asked the company the same questionTheir reply was: Their business is doing great in Europe/Asia and they don't see the need to enter the US market currently as they are at capacityMaybe that's just a diplomatic business reply we will never know
Although the main component of Ellanse is FDA-approved for use as a suture material, the filler itself has not as yet received FDA-approval as an injectable filler. Ellanse is a semi-permanent filler and collagen stimulater, and, as such, the results of its use as filler may be quite...
Ellanse works by stimulating your skin to produce new collagen- this results in a long lasting effect. Sorry to hear about your experience. You may wish to consult your original provider to discuss options, which may include a touch up Ellanse treatment to "balance out" the area
Ellanse M has been shown to last up to 24 months in clinical studies. It is difficult to comment on your condition without before and after photos. One possible solution would be the use of energy based devices such as Ultherapy to tighten the skin and slim the face