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 A patient before (left) and one hour after injection of 0.8 cc in each side of Restylane lidocaine with a 25-gauge Pix'L+ reinforced microcannula. |
"That is not to say that the fillers approved in the U.S. are necessarily safer to use. However, the parameters by which a filler is approved are much more stringent," says Luitgard G. Wiest, M.D., a dermatologist in private practice in Munich. "Simply due to the sheer number of fillers available, choosing the 'right' one can be very challenging."
According to Dr. Wiest, the fillers approved in Europe are not considered drugs. Instead, they are considered medical devices, making it relatively easy for them to receive a CE-mark approval. For the most part, companies only have to prove that their filler product is correctly manufactured according to specific guidelines, without the need to guarantee biological safety. FDA-approved fillers must undergo multiple and rigorous clinical trials before they may receive approval."As a practicing physician, I feel safer using FDA-approved fillers in my patients simply because those fillers have undergone rigorous scrutiny in clinical trials and more stringent examination compared to CE-marked fillers. Fortunately, there is a movement in Europe towards stricter guidelines in the approval process, including the necessity of clinical trials before a filler is approved, Dr. Wiest says.
