Filler Pen warning
June 20, 2022

A warning not to use needle-free devices like hyaluron pens for the injection of dermal fillers or hyaluronic acid has been issued in the USA.

No such warning has yet been issued in the UK.

The US Food & Drug Administration Agency this week warned aesthetic practitioners 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.

It claims the warning has been issued to protect 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.

The warning goes on as follows:

“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 says that 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.

The user typically fills the pen with a product that is purchased separately.

They say dermal filler procedures should only be performed with: “FDA-approved fillers, using needles or cannulas, in a clinical environment by licensed health care professionals.”

By Pete Richardson

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