ASDSA has been made aware of a new patient safety concern regarding Hyaluron pens, and particularly their use or potential use by children. Members have observed social media video postings of kids self-administering these pens that allegedly deliver hyaluronic acid filler into the epidermal and upper dermal layers of the skin without traditional needles or injections. The companies are marketing these devices as perfect for patients who dislike needles or injections, and as a painless treatment that can be less invasive and fast way to ‘plump and fill their lips, fine lines and wrinkles’.
The pens are medical devices first developed for insulin delivery, and use pressure technology to cause the hyaluronic acid to insert Nano Scale molecules of the hyaluronic acid filler through the skin. Consumers are being told these devices can create volume and shape and lift lips, nasolabial lines, marionette lines, 11 lines, forehead wrinkles. Additional marketing claims note that the hyaluronic acid only reaches the papillary layer of the dermis making this a safe treatment with no risk of occlusion as well as no sharp tips to puncture blood vessels.
ASDSA has reached out to the FDA about our safety concerns and hopes to work together on keeping medical devices in the hands of trained and educated medical professionals. Additionally we will be alerting the state medical and esthetician boards about these patient safety concerns. Be on the lookout for a social media, and other materials and activities to support education and awareness on this issue. If you have questions or are aware of social media related to this topic please contact us at advocacy@asds.net.
You can read ASDSA's press release on the FDA's safety communication on needle-less injectors here.