FDA Issues Warning About Use of Dermal Fillers With Needle-Free Devices

Elizabeth Mechcatie

October 08, 2021

The Food and Drug Administration issued a warning today about the use of needle-free devices for injecting dermal fillers — which are promoted to the public on social media and have resulted in serious and permanent injuries.

Specifically, the warning advises consumers 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."

According to the statement, the agency "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 fillers."

Needle-free devices and lip and facial fillers for use with these devices are being sold directly to consumers online, and are promoted on social media "to increase lip volume, improve the appearance of wrinkles, change the shape of the nose, and other similar procedures," according to the FDA warning.

The FDA points out that FDA-approved dermal fillers are for prescription use only, and should be administered only by licensed health care professionals using a syringe with a needle or cannula, and advises consumers not to buy or use lip or facial fillers sold directly to the public.

These products may be contaminated with infectious agents or chemicals. Moreover, "needle-free injection devices for aesthetic purposes do not provide enough control over where the injected product is placed," the statement adds. In addition to infections, other risks include bleeding and bruising, formation of lumps, allergic reactions, blockage of a blood vessel (which can result in necrosis, blindness, or stroke), and transmission of diseases from sharing devices.

The FDA's recommendations for health care providers include not using any aesthetic fillers with a needle-free device, and not using approved dermal fillers in such devices.

In response to a query, an FDA spokesperson did not have an estimate of the number of reports of these adverse events.

The American Society for Dermatologic Surgery Association (ASDSA) commended the FDA on the safety communication in a statement issued on October 11. In February, the ASDSA issued an alert about children using hyaluron pens to self-inject hyaluronic filler into the epidermal and upper dermal skin layers.

"I am pleased that the FDA has taken notice of this disturbing new trend, especially that of children using these devices on social media," ASDSA president Mathew Avram, MD, JD, director of the Dermatology Laser and Cosmetic Center at Massachusetts General Hospital in Boston, said in the statement. "The complexity of facial anatomy requires in-depth knowledge and expertise, and patients should always have medical procedures done by a physician who also has knowledge of adverse events," he added, urging consumers to see a board-certified dermatologist before undergoing any cosmetic procedure.

People who have problems or are concerned about having had a filler injected with a needle-free device should contact a licensed health care provider. Consumers and health care professionals should report adverse events related to injection of fillers with a needle-free device to the FDA's MedWatch program.

In addition to reporting such cases to Medwatch, adverse events can also be reported to the Cutaneous Procedures Adverse Events Reporting (CAPER) Registry, established earlier this year by the ASDSA with the department of dermatology at Northwestern University, Chicago.

Editor's note: This story was updated on October 11 with a comment from the American Society for Dermatologic Surgery Association.

This article originally appeared on MDedge.com, part of the Medscape Professional Network.


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