The U.S. Food and Drug Administration (FDA) is warning people against using a certain type of at-home lip fillers due to the risk for serious side effects and potentially irreversible complications. The agency issued an FDA Safety Communication about the dangers of needle-free dermal filler devices, often called hyaluron pens, on October 8, after learning of “serious injuries and in some cases, permanent harm to the skin, lips, or eyes.”
The at-home filler devices are billed to consumers as needle-free alternatives to in-office dermal filler procedures (where licensed providers inject FDA-approved hyaluronic acid fillers into the lips or face). Like many at-home cosmetic products, they became more popular during the pandemic among people seeking the results of real dermal fillers without the office visit. But these handheld devices and pens—also called Hyla-Pens, microinjectors, noninvasive injection pens, noninvasive nebulizer syringes, high-pressure pens, or sprayer pens—are not approved by the FDA, are not regulated, and come with a number of serious health risks.
People who buy these products “may not be aware of the serious adverse events that have been reported in connection with their use, such as permanent damage to the skin, lips, and eyes,” Binita Ashar, M.D., director of the Office of Surgical and Infection Control Devices in the FDA’s Center for Devices and Radiological Health, said in a statement. “Patients and health care providers should know that the FDA has not approved any dermal fillers for over-the-counter sale for at-home use or for use with needle-free injection devices.”
The devices are supposed to work by using high amounts of pressure “to force dermal filler into the body without a needle,” the FDA explains. Not only unlikely to deliver the desired results, they also can—and have—caused serious side effects and complications. The devices do not give people “enough control over where the injected product is placed,” the FDA says. And the filler substances, which are usually sold separately, may not contain what they claim. In fact, they might even be contaminated with pathogens or chemicals, the FDA says.
While some possible side effects may be temporary (like bleeding and bruising), others could cause permanent damage to the eyes or skin, such as scarring, discoloration, and lumps forming under the skin, according to the FDA. Potentially life-threatening complications include tissue death, blindness, or strokes resulting from the blockage of a blood vessel. If the product is contaminated with a bacteria, virus, or fungus, it could cause an infection. There is also a risk for disease transmission if more than one person uses the same device. Complications that occur “may require immediate medical attention” and some “may not be reversible,” according to the FDA.
Consumers should steer clear of these at-home, needle-free devices and fillers altogether. If you have previously used one of these needle-free products and experience any kind of adverse effect, you should see a medical provider and report what happened to MedWatch, the FDA’s online Safety Information and Adverse Event Reporting Program.
And if you are interested in getting dermal fillers to increase the volume of your lips, reduce the appearance of wrinkles, or otherwise modify the appearance of your face, stick to the real thing: FDA-approved procedures done by licensed professionals. As Dr. Ashar points out, these directly marketed at-home products are also “bypassing consultation with a licensed health care provider, a critical safety measure for patients to make informed decisions about their personal health.”
Real hyaluronic acid fillers are very safe when injected by an experienced, board-certified dermatologist or cosmetic surgeon who is using FDA-approved products in a medical setting. As with every cosmetic procedure, there’s a potential for negative effects with fillers, like an allergic reaction or, with some procedures, hitting a blood vessel. But the process is generally low-risk and, if you’re doing it with a professional, they will undoubtedly be on the lookout for possible issues. The effects from hyaluronic acid fillers are also temporary (since the filler dissolves on its own over time) and reversible (with the injection of a certain enzyme).
And if you’re not sure if real dermal fillers are the route for you, a consultation with a board-certified dermatologist or cosmetic surgeon—who can answer questions, address safety concerns, and give you an idea of the results you can expect—is a great place to start.
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