“After impact, there's microscopic blood particles, like splashback, that go up into the device. “The device is an open-ended device because it uses pressurized air,” Hall said. Hall takes issue with another aspect of the device, especially in a professional setting-the possibility for cross-contamination between patients. ![]() “If you inject right there, that’s something called the facial artery, and if you accidentally get in that artery, you can go blind.” “Press right at the corner of your nostril,” Bowe said. Other injection sites make Bowe even more nervous, like the nasolabial fold, where the nose meets the cheek and laugh lines are at their most pronounced. If those blood vessels are compressed by incorrectly placed filler, known as vascular occlusion, patients risk tissue necrosis: cell death due to irreversible trauma. “There are very important blood vessels and nerves that flow through the different layers of both the mucosal lip as well as the skin surrounding the lip,” she said. Bowe warned that imprecise injections can cause filler to ball up, forming insightly bumps in the lips, and more pressingly, they can also restrict blood flow. Those risks range from the aesthetic to the medical. “You're dealing with blood vessels, you're dealing with nerves, you're dealing with anatomy that can have very serious repercussions if procedures are not done properly.” “There's a lot of training involved with understanding the anatomy and understanding injection technique, so that you can minimize risks,” Bowe said. Thiersch noted in MedEsthetics that the FDA “has not approved any needle-free injector for use with hyaluronic acid fillers,” and that because needle-free injectors are medical devices, practitioners must legally hold “the same type of professional license required to inject using a needle and syringe.” Sounds rigorous? It is-for a reason. Healthcare attorney and founder of American Medical Spa Association Alex R. “Taking a skincare product that's developed and formulated to be used topically and injecting it into her lips using this at-home device, with non-sterile technique… I was prepared to respond to that on a day when I wasn’t in the office, but she had already taken it down.” “I actually saw where a young woman was using a very similar device, but with a hyaluronic acid serum,” Bowe said. A 2019 investigation by OneZero found that there are several online marketplaces that cater to DIY injectable needs, but Bowe has also seen people resort to other methods. She said she was happy with her results.īowe said the pens could be specially dangerous in the hands of amateurs with no background in cosmetic injections-and no legal means of obtaining dermal filler for at-home use without a prescription or medical license (though the empty pens can be acquired without one). “I had some lip filler done at a Med Spa to restore some of the volume lost in my lips due to aging, and was curious to hear about the experiences of other women,” Snook said. ![]() She said she spent time Googling the device and eventually decided to take the plunge and try the hyaluron pen for herself. Stacy Snook, a cosmetologist and former spa owner who films beauty and wellness content for her channel Gorgeously Aging, said she first came across the pen after watching lip filler before and after videos on YouTube. ![]() The pen’s popularity in the realm of beauty content stretches back into the late 2010s, with YouTubers touting the device and instructing their subscribers on how to use it. While the FDA would not speak directly to the case of the hyaluron pen, the spokesperson clarified that dermal fillers are class III medical devices subject to the FDA's approval, which would mean marketers of the hyaluron pen are treading legally questionable territory by suggesting it is an adequate, or even superior, substitute for FDA-approved injectables. “There's a lot of science that goes into developing the exact needle, or cannula.” Reached for comment, the FDA pointed VICE to its list of approved dermal fillers, which does not include the hyaluron pen. “When we use injectable syringes and certain needles in the office, they actually have been studied in FDA trials in a way that they deliver the product in a very safe and very specific manner,” Bowe said.
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