The FDA issued a safety alert on Friday warning against the use of needle-free injection devices for lip or facial fillers — such as hyaluron pens for injecting hyaluronic acid — as these devices are unapproved and have been linked with serious injuries.

Patients “may not be aware of the serious adverse events that have been reported in connection with their use, such as permanent damage to the skin, lips, and eyes,” said Binita Ashar, MD, director of the Office of Surgical and Infection Control Devices at FDA’s Center for Devices and Radiological Health, in a statement. “These unapproved needle-free devices and fillers are often sold directly to customers online, bypassing consultation with a licensed health care provider, a critical safety measure for patients to make informed decisions about their personal health.”

The handheld devices, or pens, use pressure to force dermal fillers into the skin, and despite being unapproved to do so, are marketed under an array of names — high-pressure or sprayer pens, Hyaluron Pens, Hyla-Pen, microinjectors, noninvasive injection pens, and noninvasive nebulizer syringes. The lip or facial fillers themselves, used to smooth wrinkles or alter the shape of the nose or increase lip volume, are typically sold separately.

Only prescription-use dermal fillers are FDA approved, the agency noted, which are administered with a syringe or cannula in a clinical setting by a licensed healthcare worker.

Ashar noted that the FDA is “monitoring” online platforms where these devices are sold and promoted. “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,” she said.

Risks with the devices include allergic reactions; bleeding; bruising; bacterial, fungal, or viral infections; the potential for disease transmission if shared with others; blood-vessel blockage that can lead to necrosis, blindness, or stroke; scarring; damage to the eyes from the device pressure; and skin lumps or discoloration.

The agency recommends that clinicians report any patient adverse events involving these needle-free injection devices to FDA’s MedWatch.