FDA warns against using over-the-counter lip and facial fillers with unauthorized needle-free devices

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The FDA has not cleared any dermal fillers for over-the-counter sales or at-home use, it affirmed in a new safety alert. Those products are often marketed for use with injection “pens,” which use high pressure rather than a needle to force fillers into the face and which are also unauthorized by the agency. (FDA)

The FDA’s crackdown on online sales of unauthorized medical devices and substances rages on. The latest to be placed on the chopping block are dermal fillers sold over the counter and the at-home, needle-free devices used to inject them—none of which have been cleared by the FDA.

The agency issued a safety alert this month affirming that fact and warning both consumers and healthcare providers against using any unauthorized fillers or injection devices.

Facial and lip fillers are typically used in cosmetic procedures to reduce the appearance of wrinkles, increase lip size, temporarily alter nose structure and more. The most common are composed of hyaluronic acid, and the only fillers cleared by the FDA must be injected with a needle or cannula by a licensed healthcare professional, such as a dermatologist or plastic surgeon.

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Despite those regulations, according to the agency, some dermal fillers are illegally being sold directly to consumers, often through online marketplaces.

Many of these over-the-counter fillers are meant to be used with at-home injection devices—again, none of which have been OK’d by the FDA—which use high pressure rather than needles to force facial or lip fillers into the skin. The hand-held devices are marketed under names like Hyaluron Pen and Hyla-Pen, and using descriptors like microinjectors, noninvasive injection pens, noninvasive nebulizer syringes, high-pressure pens or sprayer pens.

The unregulated fillers and devices have been linked to serious adverse events, including “permanent damage to the skin, lips and eyes,” Binita Ashar, M.D., director of the surgical and infection control devices division within the FDA’s Center for Devices and Radiological Health, said in the safety alert.

The risks associated with fillers sold online stem from the possibility that they may be contaminated with chemicals, infectious organisms and other undisclosed substances. The needle-free devices, meanwhile, don’t offer enough control over where the filler is injected, according to the FDA, which could lead to blood vessel blockages, scarring, discoloration and other complications.

“The FDA is monitoring online platforms for these unapproved needle-free devices as well as dermal fillers intended for use with needle-free injection devices,” Ashar said. “We also want patients and providers to be vigilant by understanding which products have been approved by the FDA and the dangers of using unapproved products, some of which may be irreversible.”

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In recent years, the regulatory agency has majorly stepped up its efforts to stop the sale of unauthorized supplements, devices and other medical materials in online marketplaces like Amazon. Lately, that work has centered largely on pulling products claiming to cure or prevent COVID-19, as well as unvetted diagnostic tests for the virus, from online store shelves.

Outside of the COVID crackdown, the FDA has continued to monitor online offerings for unauthorized substances. In July, for example, it sent a letter to Amazon requesting the immediate removal of dozens of unregulated products marketed for weight loss and sexual enhancement that it found contained “undeclared and potentially harmful drug ingredients.” The FDA also asked the online retail giant to develop a plan to prevent products like those from being listed again—especially since, as the letter noted, this wasn’t the first time unauthorized drugs were found lurking on Amazon’s shelves.