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Needle numb: FDA approves first HA-lidocaine filler for U.S. market

Article-Needle numb: FDA approves first HA-lidocaine filler for U.S. market

Key iconKey Points

  • The first hyaluronic acid filler with lidocaine recently received FDA approval
  • More HA fillers containing lidocaine are expected to enter the U.S. market

Dr. Niamtu
SANTA BARBARA, CALIF. — The recent FDA approval of Prevelle Silk (Mentor, Santa Barbara, Calif.) represents the first in what will likely be a wave of hyaluronic acid (HA) dermal fillers containing lidocaine coming to the U.S. market.

The product was approved in March after a controlled clinical study indicated that patients experienced significantly less pain during injection with the product compared to an HA product without lidocaine. It is indicated for injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).

Dr. Lorenc
HA fillers such as Juvéderm Ultra (Allergan, Irvine, Calif.) are already sold in Europe in formulas containing lidocaine and more are expected to hit the U.S. market as companies see consumer and marketing appeal in including an agent to reduce pain during injection. But with many physicians already going the extra yard to reduce pain well before the syringe is even filled, some question the value of a pain reliever that can take effect practically after the fact.

THE NUMB-ER THE BETTER "The issue with a hyaluronic acid filler with lidocaine is that it doesn't work until you actually start injecting patients, and these injections are so quick, by the time the lidocaine takes effect, you're almost finished," Joe Niamtu, D.M.D., tells Cosmetic Surgery Times.

Dr. Butterwick
"Given a choice between a product without lidocaine or with it, I would indeed get one with it. But that's not going to be my front line for pain control," says Dr. Niamtu, a Richmond, Va.-based oral and maxillofacial surgeon specializing in cosmetic surgery.

Like other aesthetic practitioners, Dr. Niamtu begins numbing patients as soon as they sit down in the chair. He practices a three-step process to ensure patients' comfort during dermal filler procedures.

"We first give the patient a potent topical anesthetic to the skin or mucosa. Then we provide ice to increase the numbness. And then patients are given what I call a 'mini-block' injection technique involving a 1-cc syringe [of lidocaine] and a 32-gauge needle," he says.

"From then on, the filler injection is effortless — and there's no doubt that the doctor can do a better job with a numb patient. The patient will appreciate the experience much more by being anesthetized."

Plastic surgeon Z. Paul Lorenc, M.D., is another firm believer in pain prevention that goes beyond lidocaine upon injection.

"I perform a complete infraorbital or mental block on all patients receiving fillers so that I can be sure they don't have any discomfort," explains Dr. Lorenc, an assistant professor of plastic surgery at the New York University School of Medicine.

"The inclusion of lidocaine may be a great marketing point for these fillers, but I would still do a block with it. So, would it make a difference in a practice such as mine? No," he asserts.

Dermatologist Kimberly Butterwick, M.D., has worked with Prevelle Silk and, in a statement provided through Mentor, says she has found that the lidocaine could, in fact, negate the need for a block altogether.

"I didn't believe it [at first], but it can actually be injected in most patients into the lips without a block and certainly on the rest of the face with topical only," says Dr. Butterwick who practices in La Jolla, Calif.

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