ASDSA Lauds FDA for Safety Communication on Needle-less Devices

The FDA recommends not using these devices; buying or using lip or dermal fillers sold directly to the public; and injecting oneself or others with any filler.

The American Society for Dermatologic Surgery Association (ASDSA) applauds the U.S. Food and Drug Administration (FDA) for sending out a safety communication regarding needle-less devices, such as hyaluron pens (HA pens) for injection of dermal fillers. 

ASDSA had earlier sounded the alarm on these devices, and Modern Aesthetics’ magazine also covered this topic in a recent Beauty Counter MD with Jeanine B. Downie, MD. “Injecting yourself with hyaluronic acid or any other filler substance is completely unsafe,” Dr. Downie warned. “It is one thing for a diabetic to be taught to inject insulin, but it is quite another thing to use a pen to forcefully inject filler into your forehead.”

The FDA recommends not using these devices; buying or using lip or dermal fillers sold directly to the public; and injecting oneself or others with any filler. 

“I am pleased that the FDA has taken notice of this disturbing new trend, especially that of children using these devices on social media. We urge consumers to see a board-certified dermatologist before undertaking any cosmetic procedures to make sure all medical questions can be answered prior to treatment,” says ASDSA President Mathew Avram, MD, JD, in a news release.  “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.”

ASDSA urges its members to report adverse event to the CAPER Registry, a partnership between ASDSA and Northwestern University’s Department of Dermatology. ASDSA members should also report applicable events to MedWatch, the FDA Safety Information and Adverse Event Reporting program.