FDA In Brief: FDA Warns Public and Health Care Professionals Not to Use Needle-free Devices for Injection of Dermal Fillers

FDA in Brief

• For Immediate Release: October 08, 2021

The following quote is attributed to Binita Ashar, M.D., director of the Office of Surgical and Infection Control Devices in FDA’s Center for Devices and Radiological Health:

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“Today, the FDA is warning the public and health care professionals not to use needle-free devices such as hyaluron pens for injection of hyaluronic acid or other lip and facial fillers, collectively and commonly referred to as dermal fillers or fillers. The FDA’s priority is protecting patients, who 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.

Patients and healthcare providers should know that FDA has not approved any dermal fillers for over-the-counter sale for at-home use or for use with needle-free injection devices. 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 FDA is monitoring online platforms for these unapproved needle-free devices as well as dermal fillers intended for use with needle-free injection devices. 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. The FDA will continue to alert the public and take additional actions as necessary in order to protect public health.”

Additional Information

• Today, the FDA has issued a safety communication to alert the public and health care providers not to use needle-free injection devices for fillers, which have not been approved by the FDA. • Needle-free devices are being used for injection of hyaluronic acid or other lip and facial fillers, collectively referred to as dermal fillers or fillers, and are marketed as Hyaluron Pens, Hyla-Pen, microinjectors, noninvasive injection pens, noninvasive nebulizer syringes, high pressure pens or sprayer pens. The marketing of these products has not been approved by the FDA.
• Needle-free devices being used for injection of hyaluronic acid or other lip and facial fillers are handheld devices or “pens” that use high pressures to force dermal filler into the body without a needle. They are being used in patients seeking to reduce the appearance of wrinkles, increase lip volume or change the shape of the nose. The user typically fills the pen with a product that is purchased separately.
• The FDA has not approved any hyaluronic acid or other lip and facial fillers for over-the-counter sale for at-home use or for use with needle-free injector devices. Dermal filler procedures should only be performed with FDA-approved fillers, using needles or cannulas, in a clinical environment by licensed health care professionals.
• The FDA is monitoring how these unapproved devices are sold online as part of the agency’s actions on unapproved products on online marketplaces and will take additional actions as necessary.