The Food and Drug Administration (FDA) has issued a safety communication to warn the public and health care professionals not to use needle-free devices for injection of dermal fillers, such as hyaluron pens for the injection of hyaluronic acid or other lip and facial fillers.
Dermal fillers are used to smooth out wrinkles in the face and hands and are usually considered to be temporary, creating a plumping effect for six months or longer. FDA-approved dermal fillers are for prescription use only with a syringe and either a needle or cannula. The warning regarding needle-free devices, and the lip and facial fillers used with them, is related to products sold directly to consumers online. These devices have not been evaluated for safety and effectiveness by the FDA. The products sold online are not believed to provide enough control over the placement of the injected fillers, which can lead to undesirable outcomes. Because these products are not regulated by the FDA, there is a risk they may be contaminated with chemicals or infectious organisms, which can lead to infections, scarring, bleeding or bruising, skin discoloration, lump formation in the skin, allergic reactions, blockage of blood vessels, and eye damage secondary to pressure from the needle-free device.
Nurses and other health care providers should be aware that needle-free devices for dermal fillers, and the fillers that are sold with them, are not FDA approved and that all approved dermal fillers require the use of a syringe with a needle or cannula. Nurses should instruct patients interested in using dermal fillers not to purchase any needle-free devices and products over the internet, as all approved products require a prescription. If a patient has used a dermal filler and needle-free device and has experienced a problem, they should seek medical assistance. These events should be reported to the FDA's MedWatch system at http://www.accessdata.fda.gov/scripts/medwatch/index.cfm.
To read the full FDA Safety Communication, go to http://www.fda.gov/medical-devices/safety-communications/do-not-use-needle-free-.