FDA warns public not to use popular 'hyaluron pen' cosmetic device

Posted at 5:33 AM, Oct 27, 2021

BROOKFIELD, Wis. — The hyaluron pen promises to plump lips and smooth out fine lines on the face. But the U.S. Food and Drug Administration is warning consumers and health professionals not to use the cosmetic device.

People who use the pens tell the I-Team a big appeal is that they're needle-free. They use high pressure to force dermal filler into the skin.

This TikTok video posted by a nurse practitioner ( shows how the hylaron pen works versus a dermal filler with a needle.

"I really liked it. I did not have any side effects. I did not have any problems with it," said Ashley.

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She shared these before and after pics with the I-Team showing her plumper lips.

"The most beautiful part of it all is that my lips didn't go down," she said.

Ashley says the cost is also a plus. The beauty business she went to in California charges about $250 for the procedure. Online, consumers can find even cheaper prices for the pen and filler.

Compare that to needle injections. According to, most dermal fillers range in price between about $600 and $1,000 per syringe.

Kathy Mortl with Boness Body and Face Medispa in Brookfield is one of many health care professionals speaking up about why they believe the pen is not safe.

Mortl has been in the health care profession for decades. She's a registered nurse (RN), certified plastic surgical nurse (CPSN), certified aesthetic nurse specialist (CANS), and a fellow with the International Society of Plastic and Aesthetic Nurses (ISPAN).

"I started seeing images on social media and I'm like, 'Wait a minute, wait a minute. This isn't right,'" Mortl said to the I-Team.

"When you're doing these pens, it's coming from a foreign country and you don't know what it is," Mortle said.

"It's dangerous because it's the hands of people who don't have the education, the knowledge, the anatomy, the proper training," she added.

The pens aren't approved by the FDA for dermal fillers. Back in January, Mortl complained to the federal agency, pleading for something to be done.

"I'm sure there were other people reporting this too, but I was just on them, you know, I was calling them almost every two to three days. They didn't give out a lot of information, just that, 'We're working on it, we're bringing it to the people's attention,' and things like that," said Mortl.

On Oct. 8, the FDA issued a warning to the public and health care professionals not to use needle-free devices for injection of dermal fillers and listed the pen by name, stating "'s aware of serious injuries and in some cases, permanent harm to the skin, lips or eyes with the use of needle-free devices..."

"What do you think of that warning?" the I-Team asked Ashley.

"To be honest I didn't even hear about the warning," she said.

"I feel what they might be saying is that everything you put into your body that's not natural, that's foreign, it comes with risks. That's completely normal," she continued.

Ashley felt safe having a specialist use the pen on her. She plans on going back for more treatments.

"I do feel that people may be going a little overboard with it," she said.

"I feel people are buying it for their home use and misusing it, which is causing problems," she continued.

Mortl has co-written an article in the International Society of Plastic and Aesthetic Nurses Journal about the dangers of the hyaluron pen.

For her, the fact that anyone can use this tool capable of extremely high pressure without any training or license is probably the scariest part.

"If the dermal filler or this substance gets into a vein or an artery, it can block the flow of blood and you can have tissue necrosis, you can have very large nodules, uneven, disfiguring," said Mortl.

"This is a very dangerous device," said Mortl. "Since the popularity of it and just seeing what is being sold online it just scares me, it literally scares me."

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