These unapproved, needle-free devices and fillers are often sold directly to customers online.
YORK, Pa. — The beauty industry was hit hard during the pandemic, with many medical spas having to close their doors. Now, video after video online show people trying to take beauty into their own hands at home.
Many are using specialized pens marketed as facial fillers to either plump their lips or minimize wrinkles and fine lies and now, the FDA is issuing a strong warning to consumers about their dangers.
“If you’re doing it yourself and you don’t have the training or the tools, you’re blasting something under the skin with no precision and no training; it’s incredibly hazardous,” Dr. William Carter of Medical Cosmetics of Lancaster said.
He says facial fillers are a popular procedure, but must be done by a professional. Even then, there can be issues.
“The people who inject fillers into faces legitimately spend a lot of time, effort, and money getting trained to do this safely and even the best injectors will have complications in the course of their practice from time to time,” he said.
Most of the devices are called hyaluronic pens that use heavily pressurized air to force fillers into your skin instead of using a needle. They can easily be found online for purchase but nobody really knows what ingredients are inside.
Dr. Carter says, “if you buy non-FDA approved material, you’re setting yourself up for infection, disfigurement. Under the wrong set of circumstances it would be easy to cause blood vessel inclusion, and areas of your facial skin could die and doing this can even cause blindness or strokes.”
The FDA has just released this strong warning, writing in part: “the FDA has not evaluated nor approved the safety and effectiveness of needle-free devices for injection of any dermal filler. The FDA is aware of serious injury and in some cases, permanent harm to the skin and lips. Needle-free injection devices for aesthetic purposes do not provide enough control over where the injected product is placed. Lip and facial filler products sold directly to consumers online may be contaminated with chemicals or infectious organisms.”
For a look at the full FDA warning, as well as consumer recommendations, click here.
Right now, the FDA says they are still investigating and will take action, if necessary. Dr. Carter says the FDA’s involvement is rare.
“For them to take a stand on something that’s a consumer related item or marketed that way, is a very powerful statement indeed,” he said.
That’s because the FDA’s legal authority over cosmetics is different from other things they regulate, such as drugs, biologics, and medical devices. Under the law, cosmetic products and ingredients do not need FDA premarket approval, with the exception of color additives. However, the FDA can pursue enforcement action against products on the market that are not in compliance with the law, or against firms or individuals who violate the law.
Experts say if you’re that desperate for luscious lips at home, maybe try something temporary, like plumping lip glosses, which are generally considered safe.
If you’d like to reach Dr. William Carter at Medical Cosmetics of Lancaster, click here.
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