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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.

Needle-free injectors are handheld devices or “pens” that use high pressure to force substances, such as fillers, into the body. The substances loaded in the pens are typically sold separately.

The FDA is aware that needle-free devices, and lip and facial fillers for use with these devices, are sold online directly to the public, and their use is promoted on social media to increase lip volume, improve the appearance of wrinkles, change the shape of the nose, and other similar procedures.

The FDA has not evaluated the safety and effectiveness of needle-free devices for injection of any dermal filler. 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).

Needle-free injection devices for aesthetic purposes do not provide enough control over where the injected product is placed. Lip and facial filler products sold directly to consumers online may be contaminated with chemicals or infectious organisms.

Complications may require immediate medical attention by a licensed health care provider.

Some complications may not be reversible.

The FDA is monitoring reports of adverse events associated with needle-free devices for injection of fillers and will update the public if significant new information becomes available.

Marketing of prescription medical devices for purchase without a prescription is prohibited and may be subject to civil or criminal penalties. The FDA continues to evaluate marketing of needle-free devices for injection of fillers and will take action, as necessary.

If you think you had a problem with needle-free devices for injection of fillers, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.

Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

If you have questions, email the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV or call 800-638-2041 or 301-796-7100.