FDA APPROVAL-Less Discomfort when Using Fillers!!

FDA Approves New Lidocaine-Containing Dermal Filler FormulationFebruary 2, 2010 —         The US Food and Drug Administration (FDA) has approved a new formulation for a hyaluronic acid dermal filler (Juvederm XC, Allergan, Inc) that contains a local anesthetic to enhance patient comfort when treating moderate to severe facial wrinkles and folds.

As with the original version (Juvederm, Allergan, Inc), the injectable gel product lasts up to 1 year from initial treatment. The addition of 0.3% lidocaine numbs the treatment area within seconds, potentially decreasing the need for additional anesthetic.

“Patients want a smooth and natural-looking result from a dermal filler treatment, but as a physician I am also interested in managing my patient’s discomfort during the injection. Before the introduction of Juvederm XC, it often took up to 30 minutes for an anesthetic block to take effect.” said Charles Boyd, MD, Boyd Cosmetic Surgical Institute and clinical investigator in a company news release. “[W]ith the new formulation, patients can receive the same smooth results as demonstrated with Juvederm but enjoy a more comfortable injection experience.”

FDA approval was based on data from a multicenter, double-blind, randomized clinical trial in which 72 patients received 1 of the 2 formulations in each nasolabial fold. Results showed that 93% of patients reported less procedural pain when treated with the lidocaine-containing dermal filler compared with the original version.

The safety profile was similar for both products, with temporary injection-site erythema, inflammation, pain/tenderness, firmness, lumps/bumps, and bruising most commonly reported. Most adverse events were mild to moderate in nature and of short duration (≤7 days).

With FDA approval, the lidocaine-containing dermal filler is available by prescription nationwide. As with the original formulation, it should only be administered by a trained medical professional.

Disclaimer: This blog or article is for information purpose only, and should not be treated a professional advise or price protection guarantee.

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