Hyaluron pen dangers: Popular lip filler device not approved by FDA

PHOENIX - Men and women have been attempting to achieve fuller, plumper lips through different cosmetic treatments for years.

Most recently, people are trying a process they do at home, but a Valley woman is sending out a warning to leave it to medical professionals.

"If I didn't seek the help that I needed, my story would've been different," Ana Coronado said. "I don't know what would've happened. My tissue would've been dead. I don't know if I would've had lips right now."

Coronado took video of her lips on February 16. The morning after she says she used a hyaluron pen to plump her lips, she was on her way to see a registered nurse aesthetician.

"I was just crying of pain and just being emotional because I had did this to myself," she said.

A quick search on YouTube shows just how popular these products are, with thousands of videos showing how the device works, with links to buy them, and how to use them.

"It's like a rubber band… have you ever had a rubber band snap at your skin? It's that type of feeling," Coronado said.

The pen, which relies on extremely pressurized air to administer non-medical grade hyaluronic acid at a high speed, creates steam that spreads the filler under the skin of the lips. It's not FDA-approved, nor is the filler Coronado used. She says both were purchased online for about $50 each.

"You can buy the pens anywhere, you just go on Google and you, Google like hydro pens, and you find them," Coronado said.

In October 2021, the Federal Drug Administration issued a warning about hyaluron pens, asking both the public and professionals to stay away from the needle-free devices. The FDA stressed that the only dermal fillers approved for use are supplied to licensed health professionals with a prescription. The FDA also warns the pens do not provide enough control over where the filler will be placed and can cause permanent harm to the skin lips and eyes.

Brandie Henderson is a certified aesthetic nurse and the owner of Morph Aesthetics.

"My main fear was the compression she was having," she said. "They were very, very tight, very swollen. I wasn’t worried that she had an occlusion or narcosis of her lips once I saw the video, but I was really worried about the compression."

Henderson didn't know what substance exactly was used or where it was placed, but she knew it had to go – she injected four vials of a dissolvent.

"If you're a medical professional, you know there’s arteries in vessels that you can get in, and you can include, and they can even travel all the way up and cause blindness, so there’s a lot of things that we, as providers, worry about and are trained on how to handle them, and we have protocols in place," she said.

Coronado was fortunate that the product started to dissolve. After one treatment with Henderson, this is what they looked like, and they're not done yet.

This was actually Coronado's fourth time using a pen and filler like this. She says she wanted to save money and has a fear of needles – a difficult lesson she hopes others learn from.

"It was more because I’m, I’m afraid of needles," she said. "That was the thing for me. I don’t like needles and that was like an alternative at it for me, but yeah, now I don’t care. I’m not afraid of needles anymore."

Morph Aesthetics charges $700 for lip filler. Coronado says she spent almost that much buying the pens and fillers when it was all said and done. One vial of the product used to dissolve filler costs about $200. Henderson says she didn't charge Coronado for that service because she just wanted to help.