FDA Safety Communication warns public about needle-free device use

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 (HA), or other lip and facial fillers, collectively and commonly referred to as dermal fillers or fillers. 

The FDA is aware of serious injuries and in some cases, permanent harm to the skin, lips, or eyes with the use of needle-free devices for injection of fillers. 

The FDA has not evaluated the safety or effectiveness of needle-free devices for injection of fillers. The FDA also has not approved the marketing of needle-free devices for injection of these products. FDA-approved dermal fillers are intended for prescription use only and for use with a syringe with a needle or cannula (a small flexible tubing with a blunt tip that is inserted using a needle). 

This safety communication provides: 

  • Important recommendations for consumers who are considering or currently using needle-free devices for injection of fillers. 
  • Recommendations for health care providers. 
  • Background and risks associated with the issue. 
  • Instructions for reporting problems with needle-free devices for injection of fillers to the FDA.