In a recent safety communication issued by Food and Drug Administration (FDA) on 8 October 2021, the use of needle-free devices is not considered safe for injection of the lip, facial and other derma fillers. This safety advisory has been issued in public and health professionals interest to warn about the adverse events associated with the use of needle-free devices.

These unapproved needle-free devices are marketed as Hyla-pen, hyaluronic pens, micro-injectors, high-pressure pens, sprayer pens, non-invasive injection pens and nebulizers and sold over the counter without the consultation of a licensed health care provider. They are being promoted to reduce wrinkles, increase lip volume and even change the nose shape.

Health care providers and patients should be aware of the fact that these devices are not approved by the FDA and are associated with serious side effects such as permanent damage to the area of use such as eyes, skin and lips. Safe and approved derma fillers are intended for use by licensed health care professionals using a needle, syringe or cannula and are for prescription use only.

FDA will be monitoring the online platforms that have been selling and marketing these unapproved needle-free devices and will take necessary actions to protect public health. Also, patients and health care providers should be vigilant about the dangers of unapproved products and should not use these needle-free devices without physician consent.