|The U.S. Food and Drug Administration (FDA) is warning the public and health care professionals not to use needle-free devices such as hyaluron pens for injection of hyaluronic acid (HA) or other lip and facial fillers, collectively and commonly referred to as dermal fillers or fillers.|
|The FDA is aware of serious injuries and in some cases, permanent harm to the skin, lips, or eyes with the use of needle-free devices for injection of lip and facial fillers.|
The FDA has not evaluated the safety or effectiveness of needle-free devices for injection of fillers. The FDA also has not approved the marketing of needle-free devices for injection of these products. FDA-approved dermal fillers are intended for prescription use only and for use with a syringe with a needle or cannula (a small flexible tubing with a blunt tip that is inserted under the skin).
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