The US Food and Drug Administration (FDA) has issued a safety communication regarding the use of needle-free injection devices for fillers.
According to the FDA, the needle-free devices are marketed as Hyaluron pens, Hyla-Pen, microinjectors, non-invasive injection pens, non-invasive nebuliser syringes, high pressure pens or sprayer pens.
The association 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. 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.
Binita Ashar, director of the Office of Surgical and Infection Control Devices in FDA’s Centre for Devices and Radiological Health, said, “The FDA is warning the public and healthcare professionals not to use needle-free devices. The FDA’s priority is protecting patients, who may not be aware of the serious adverse events that have been reported in connection with this use, such as permanent damage to the skin, lips and eyes.”
Plastic surgeon Dr Ashwin Soni, who wrote on needle-free injector pens in the July issue of Aesthetics which you can read here, commented, “I am in support of the FDA warning that needle-free filler pens should not be used given the safety issues that surround these devices. There cannot be precision with injector pens, with regards to the depth of penetration and dispersion of the filler, and there have been many complications globally from the use of these devices.”