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Understanding varying filler technologies, properties critical to selection success

Article-Understanding varying filler technologies, properties critical to selection success

Key iconKey Points

  • Fillers in Europe are considered medical devices, not drugs
  • Even fillers that are FDA-approved can result in adverse events
  • Longer-lasting fillers are useful in patients with lipoatrophy where volumization is needed as a final solution

Hundreds of fillers are available in aesthetic medicine today, and choosing the appropriate product for a given cosmetic indication can be a daunting task. Careful patient selection, proper training and experience remain the common denominators in helping to avoid adverse events with fillers.

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.
The road to the approval of fillers can vary greatly between the Food and Drug Administration (FDA) and receiving a CE-mark in Europe. Currently, there are more than 200 fillers available on the European market used for a variety of cosmetic indications. In the United States, there are only about a dozen FDA-approved fillers.

"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.

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