FDA Warns Against Using At-Home Dermal Filler 'Pens'
Serious adverse events have been reported in connection with dermal filler use, such as permanent damage to the skin, lips, and eyes
By Robert Preidt and Ernie Mundell (HealthDay News) | October 14, 2021
The U.S. Food & Drug Administration on Friday warned the public and health care professionals against the use of unapproved "at home" dermal filler pens, bought without a prescription.
These needle-free devices, such as hyaluron pens for injection of hyaluronic acid or other lip and facial fillers, use high pressure to force dermal filler into the body without a needle.
"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," Binita Ashar, M.D., said in an agency news release. She directs the Office of Surgical and Infection Control Devices in the FDA Center for Devices and Radiological Health.
Seeking to bypass more expensive -- but much safer -- injections from trained professionals, some consumers are using the over-the-counter devices to reduce wrinkles, increase lip volume, or change the shape of the nose. Users typically fill the "pen" with a product that is bought separately. But Ashar said her agency "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."
"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," she said.
The FDA advised that consumers who would like to get dermal fillers should stick to procedures done in a clinical setting by licensed health care providers using FDA-approved fillers with needles or cannulas (thin tubes).