The FDA Is Warning Against the Use of These At-Home Lip-Plumping Devices

Hands holding up smartphones with lips floating in the scene on a pink gradient backgroundIllustration by Bella Geraci / Getty Images

UPDATE (October 13, 2021): The U.S. Food and Drug Administration has released a safety communication in response to the injuries caused by the use of devices like hyaluron pens for the injection of fillers. The October 8 statement is addressed to both consumers and medical professionals and warns them of the risks associated with these unapproved tools, which have recently seen a surge of popularity on social media, and making recommendations for what to do and not do regarding dermal fillers.

"The U.S. Food and Drug Administration (FDA) is warning the public and health-care professionals not to use needle-free devices such as hyaluron pens for injection of hyaluronic acid (HA) or other lip and facial fillers, collectively and commonly referred to as dermal fillers or fillers," the statement reads about the devices, which the agency says use high pressure to force substances like filler into the body. "The FDA is aware of serious injuries and in some cases, permanent harm to the skin, lips, or eyes with the use of needle-free devices for injection of lip and facial fillers."

Among the recommendations provided for consumers, the FDA advises not to undergo any filler procedure with needle-free devices, not to buy or use fillers sold directly to the public (as they are indicated for prescription use only), and not to inject yourself or others with lip and facial fillers using any device. For health professionals, the FDA recommendations include not performing any aesthetic filler procedures with needle-free injection devices, not transferring FDA-approved dermal fillers into needle-free injection devices, and not using injectable filler products that are not FDA-approved dermal fillers. 

"The FDA is aware that needle-free devices, and lip and facial fillers for use with these devices, are sold online directly to the public, and their use is promoted on social media to increase lip volume, improve the appearance of wrinkles, change the shape of the nose, and other similar procedures," the statement reads, adding that FDA-approved dermal fillers are intended for use only with a syringe with a needle or cannula. "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."

The FDA says risks include bleeding or bruising; infection with bacteria, fungus, or virus from the filler or needle-free device; transmission of disease between people who use the same needle-free device; blockage of a blood vessel, leading to tissue death, blindness, or stroke; scarring; damage to eyes from the pressure of the needle-free device; formation of lumps in the skin; discoloration of the skin; and allergic reactions. The agency is monitoring reports of side effects and adds that marketing of prescription medical devices for purchase without a prescription is prohibited and may be subject to civil or criminal penalties. 

In addition to immediately seeking care from a licensed health-care provider in the event of adverse effects caused by using a needle-free device like a hyaluron pen, the FDA urges contacting MedWatch, the agency's Safety Information and Adverse Event Reporting program to report the issue.

This post originally appeared on May 28, 2021:

Last spring, in the earliest days of the pandemic, with stay-at-home orders firmly in effect and nonessential services suspended, DIY took on a radically new meaning. When masks were scarce, we made our own from retired denim and unworn scarves. When schools shuttered, we subbed for teachers, deftly juggling the many platforms required to educate a first-grader from the couch. We baked our own bread. Painted our own walls. Tended our own gardens.

The traditionally service-oriented beauty realm saw perhaps the most dramatic shift, as people learned to cut their own hair and do their own quarantine manicures. At the most extreme end of the spectrum were those performing DIY dermatological treatments, like mole removal (wrong on so many levels), and even more outrageous, filler injections — a trend that has persisted despite dermatologists and plastic surgeons being back in business for nearly a year now.

Driving the movement, TikTok and YouTube have become unfiltered how-to hubs for amateurs wanting to inject hyaluronic acid (HA) into their own lips, noses, and jawlines using easy-to-get gadgets called hyaluron pens.

What exactly are hyaluron pens?

Available across the internet, these needle-free devices use pneumatic pressure to push hyaluronic acid into the skin. Compared to the needles and cannulas that doctors use to inject filler, hyaluron pens offer less control over the speed and depth at which the HA is delivered. "It's an uncontrolled, uncalibrated pressure, so you can actually get different levels of pressure depending on the press," notes Zaki Taher, M.D., a board-certified dermatologist in Alberta, Canada.

And there's a lot of variability between brands. In YouTube and TikTok videos, some of the hyaluron pens we investigated appeared to deposit product atop the lips, seemingly too weak to pierce the skin (assuming they were being used properly). Others garnered reviews warning of their intensity and advising shoppers against using them on any area of the face.

For the most part, the pens frequently featured in online reviews — which range in price from around $50 to a few hundred dollars — claim to penetrate from approximately five to 18 millimeters deep and fire with an advertised force of roughly 1,000 to 5,000 pounds per square inch (PSI). "To put it into perspective, an average punch in the face is estimated to be 65 to 80 PSI, and bullets have a force of 1,000 PSI and up," says Hema Sundaram, M.D., a board-certified dermatologist in Fairfax, Virginia, and Rockville, Maryland. Yet, the majority of these devices somehow promise a painless experience.

Hyaluron pens are modeled after handheld jet injectors designed to get liquid medications, like insulin and anesthesia, into the skin without needles. "I was introduced to these [types of] devices probably almost 20 years ago," says L. Mike Nayak, M.D., a board-certified facial plastic surgeon in Frontenac, Missouri, who recently railed against hyaluron pens on Instagram. "There was a pen for delivering local anesthesia [and it was the] same kind of thing, a spring-loaded device — you draw up the lidocaine, click the trigger, and it generates a really quick burst of little droplets of fluid that move so rapidly they can break through the surface of the skin."

The concerns and unknowns

Today, a handful of jet injectors are approved by the Food and Drug Administration (FDA) for use with very specific drugs — one, for instance, is cleared for the administration of a particular flu vaccine — and, interestingly, some of these hyaluron-pen predecessors provide early evidence of the problems our experts say are inherent to this category of tools. "Research reports for vaccine intradermal injectors indicate that it is difficult to get consistent control on depth and location of the injection [and that] the injection site often results in additional bruising and swelling over a needle injection," says Alex R. Thiersch, an attorney representing the aesthetics industry and the founder of the American Med Spa Association.

Despite the similarities between medical jet injectors and cosmetic hyaluron pens, Shirley Simson, a spokesperson for the FDA, assures us that, "To date, the FDA has not approved a needleless injector for hyaluronic acid injection." Furthermore, she notes, "Dermal fillers are only approved to be injected by a licensed healthcare provider using a needle or, in some cases, a cannula. No dermal filler product is approved for use by the patient or at home."

Hyaluron-pen fans may argue that if certain drugs, like epinephrine and insulin, are considered safe for DIY injection, then why not HA? But in those medically acceptable scenarios, Dr. Nayak explains, "You're prescribed the needle, you're prescribed the syringes, you're prescribed the insulin — and then you're given instruction by a medical professional, who is monitoring [the process]." With HA, the hyaluron pens are not FDA-approved; there's zero oversight; and you're typically targeting the face, which is, due to its vasculature, more dangerous to inject than, say, a thigh or shoulder. What's more, Dr. Nayak adds, since "the people using these pens are unable to [legitimately] purchase FDA-approved fillers, they're purchasing black-market fillers online."

Indeed, a recent study published in the journal Dermatologic Surgery found counterfeit fillers to be a pervasive problem, with 41.1 percent of physicians surveyed having encountered untested and unverified injectables and 39.7 percent having treated patients with adverse events arising from them. Another 2020 paper published in the Journal of the American Academy of Dermatology also references the rise in unregulated internet injectables and the "growing trend of self-injecting unregulated neurotoxins and fillers under the guidance of YouTube tutorials."

"There's a lot of concern about what people are putting into these pens," says Katie Beleznay, M.D., a board-certified dermatologist in Vancouver, British Columbia. "There are so many questions around the sterility, stability, and longevity [of online fillers]." Unlike the HAs that board-certified dermatologists and plastic surgeons routinely inject, "these products haven't undergone the rigorous safety review of the FDA, so consumers have no way of knowing what they are injecting," adds Sarmela Sunder, M.D., a board-certified facial plastic surgeon in Beverly Hills. And since the average patient isn't likely attuned to the variability between individual HAs — how their viscosity and elasticity determine appropriate use and placement, or how their unique crosslinking influences swelling and durability — how are they to know which gels will actually flow through the pen or look most natural in their lips versus tear troughs versus cheeks?

The aesthetics community speaks out

Over the past few months, dozens of board-certified dermatologists and plastic surgeons have taken to social media to warn their followers about the myriad risks associated with hyaluron pens and DIY filler injections, in general.

Leading the charge was the American Society for Dermatologic Surgery (ASDS). In February, the organization issued a patient safety alert, noting in their statement that they had contacted the FDA with safety concerns surrounding the hyaluron-pen phenomenon. In March, the American Academy of Dermatology released a similar statement, cautioning that "while it may be tempting to use a needle-free 'do-it-yourself' device to inject hyaluronic acid filler purchased online into the face or lips, doing so can come with serious health consequences."

While filler complications can happen to even the most experienced injectors, FDA-approved hyaluronic acid fillers, like Juvéderm, Restylane, and Belotero, are considered very safe when injected with needles or cannulas by qualified board-certified dermatologists and plastic surgeons who know anatomy and can recognize and reverse complications should they arise. "Fillers are great treatments — they're super popular and [have] a very high satisfaction rate — but you have to know what you're doing," reiterates ASDS president and board-certified Boston dermatologist Mathew Avram, M.D. "They're potentially dangerous if you inject into the wrong area — there are reports of blindness, stroke, and [skin] ulcertions that are cosmetically disfiguring."

And oftentimes the "wrong area" can be difficult to distinguish from the right area. "A fraction of a millimeter in the right direction or wrong direction is the difference between a big chunk of your lip and nose having circulation or not having circulation," says Dr. Nayak. Given the pens' reported lack of precision, he adds, "even if I had [one], I would never consider injecting filler with it, because I'd be terrified that I don't have control over where the product is actually going." (This recent hyaluron-pen fail that Dr. Nayak's team treated is an example of what he calls "the best worst-case scenario" that could possibly result from the device's erratic product delivery: apparent filler BBs studding the surface of the patient's lips.)

The potential risks associated with hyaluron pens

While countless companies make hyaluron pens, and there appear to be slight differences between models — related primarily to advertised depths of delivery and measurements of pressure and speed — our experts insist that they largely operate by the same mechanical means and pose similar risks. "These pens are of concern and I don't feel that it would be ethical for me to comment that any [one] of these [is] necessarily better than another for use by someone who is not medically trained and extremely familiar with facial anatomy," says Dr. Sunder.

And it's this, the fundamental DIY nature of these devices, that makes them so perilous — the fact that they're "being sold to individuals unqualified to perform filler injections and inciting self-treatment," adds Dr. Sundaram.

Allure asked Dr. Sunder, Dr. Sundaram, and Kavita Mariwalla, M.D., a board-certified dermatologist in West Islip, New York, to evaluate some seen-on-social-media hyaluron pens. As expected, no needle doesn't mean no problem: hyaluron pens can threaten our health and appearance in several significant ways.

Vascular occlusion

Vascular occlusion — the most feared filler complication — occurs when a gel invades or compresses an artery, blocking blood flow and potentially causing skin loss, blindness, or stroke. "Vascular compromise is always a concern with any filler injection, regardless of how the filler is introduced into the body," Dr. Sunder says. "While some of the proponents of the pen argue [on social media] that the pen cannot infiltrate a blood vessel like a needle can, and therefore [it's] unlikely to cause a vascular event, there still exists the significant risk of vascular compromise from compression of the vessel by the filler."

Dr. Taher has seen first-hand a vascular occlusion resulting from DIY injection with a hyaluron pen. "The case that I had — she was a true vascular crisis," he says. "I saw a picture and said, 'You must come in immediately.'" On the patient's upper lip, he recognized the hallmark lacy, purple discoloration of a vascular occlusion in urgent need of reversal (which you can see here, in a PSA he posted on YouTube following treatment). With two rounds of an injectable enzyme called hyaluronidase, he was able to dissolve the clot and save the patient's skin.

Several critical facial arteries course only a few millimeters below the skin's surface. The throngs of TikTokers using hyaluron pens to plump their lips probably don't realize that "the labial arteries [which supply the upper and lower lips] can be shockingly close to the skin surface," Dr. Sundaram notes, especially in more mature skin, which has thinned with age. "At certain points along the lower lip, the artery's depth below the skin surface has been found on ultrasound imaging to range from 1.8 to 5.8 millimeters," she adds. In the same study, the artery nourishing the upper lip ranged in depth from 3.1 to 5.1 millimeters. "So the pressurized jet of HA from a hyaluron pen is certainly capable of encountering the superior labial artery, inferior labial artery, and other vital structures," Dr. Sundaram concludes.

When reviewing one HA pen tutorial on YouTube, Dr. Sundaram was dismayed to see the company inform a commenter in a reply that "yes, you can" use the pen to treat the temples, "but it's best to consult a doctor for proper technique." According to Dr. Sundaram, "the temple is a significant danger zone on the face with respect to blindness from filler injection because blood vessels in the temple have connections to blood vessels that supply the eye. The primary artery in the temple, the superficial temporal artery, runs within the fibrous tissue just under the skin and thin fat layer in this region," making it susceptible to occlusion, particularly if an injector doesn’t know it's there.

Bruising and scarring

"A pressurized injection literally has zero place on the face," says Mariwalla. To minimize complications, like vascular occlusion and ordinary bruising, "we always teach physicians to inject with low pressure and slowly."

Hyaluron pens, however, rely on high force and velocity to deliver filler into the skin. "When a device does not have a needle as a point of entry, the product needs to essentially be propelled with such force and under such high pressure that it can tear or rip through the skin," says Dr. Sunder. In the case of lip injections, "whenever significant pressure is exerted on the sensitive mucosa, there will be trauma and crush injury to a certain extent — [and] not limited just to the skin, but to the underlying blood vessels as well, as demonstrated by the bruising in many of these [hyaluron pen] how-to videos. The high pressure at which the product is introduced, as a result of injury to the mucosa, could result in long-term scar formation."

Dr. Sundaram likens hyaluron pen HA injections to "filler bullets" and the trauma they produce to the collateral damage inflicted when an actual bullet is fired into human tissue. "Common sense tells us if you're pushing a high-speed bullet under extreme air force into the skin, there will be tissue trauma."

Swelling, lumps, bumps, and asymmetrical outcomes

"These pens aren't capable of controlled, predictable treatment," says Dr. Sundaram, "because the forcing of filler at high pressure into the skin will cause it to spread unpredictably and inconsistently." Moreover, she notes, once the skin starts to swell during treatment, "the swelling is going to mask the real shape of the lips — you no longer have any semblance of accuracy in terms of where you’re putting this stuff."

She recently treated a hyaluron-pen user whose "upper lip was much bigger than the lower lip, and then one side of the upper lip was significantly larger than the other, and there was bruising, and it was lumpy," she says.

Dr. Sundaram also makes the point that pens advertising great depths are capable of reaching certain muscles, like those that move the mouth. "Ultrasound scans of the living lip — which are more accurate than cadaver studies — have shown that the orbicularis oris muscle lies about four millimeters below the skin surface," she explains. If a hyaluron pen deposits filler into that muscle, "its mobility could cause increased risk of filler lumps and bumps, and even more distant filler displacement — often incorrectly termed 'migration,'" she says.

On the flip side, if certain HAs — brawny volumizing varieties — are injected too shallowly by an unpredictable pen, they too can cause problems, like visible lumps and a bluish hue. "Some of the fillers that are being touted for use with [these pens] are actually thicker, more highly cross-linked types," Dr. Sundaram says. "If you inject those superficially, you can get Tyndall effect, [which is a] blue discoloration due to a scattering of light."

Beyond the pens' questionable depths and dispersion patterns, "the fact that [they implant] the product as a single bolus, or depot, rather than in a continuously moving linear placement is a concern from both a safety and an aesthetic perspective," Dr. Sunder says. "An experienced injector never depots product, especially in the lips." 

Mariwalla co-signs, saying, "I never inject lips [using] a serial bolus technique — it not only looks unnatural, but the patient will feel the lumps and bumps." Bolus-style injections can also heighten the risk of "vascular compromise or tissue injury," notes Dr. Sunder.

Infections and allergic reactions

The hazards here spring from two sources — the iffy substances being injected and the hyaluron pens themselves.

As previously noted, "perhaps the most concerning of all the issues is the actual filler itself," Dr. Sunder says. Beyond potential for contamination or adulteration, "I also worry that some laypeople may not understand the nuanced differences between HA intended for topical use [like a serum] and true hyaluronic acid fillers, which are intended for injection. Introducing a topical product into the skin or mucosa using these pens could cause long-term complications, such as foreign body reactions or granuloma formation," which can be quite challenging to correct.

Even if someone somehow manages to procure a pure, legitimate HA filler, getting it into the pen opens another can of worms. "[They] require the transfer of filler from its original syringe to an ampoule within the pen," notes Dr. Sundaram. "This is a multi-step process — connect the transferring syringe to a needle, draw up filler, squirt it into the ampoule — and every time it’s done, there is a risk of contamination."

Dr. Sunder adds that "even if this maneuver is performed in a medical setting, the transfer would not be sterile. But this being performed in a person’s home is a set-up for an infection."

Then there's the issue of DIY sterilization. "Each of these pens has removable parts, and the question is, how clean are the actual devices themselves?" Mariwalla says. "The companies are expecting you to inject a material of unknown origin and stability into your skin, with a device that has ridges and parts that are supposed to be cleaned how? With soap and water and dried on the dish rack? Does not seem safe to me."

Since most folks, barring healthcare workers, aren't familiar with the intricacies of sterile technique, "the likelihood is that patients are going to end up with a non-sterile HA that they're pushing into their skin," Dr. Sundaram says.

What steps are being taken to regulate hyaluron pens?

Serving as an example of what can feasibly be done to protect the public from self-harm, the Canadian health authorities issued a public safety warning on these pens in 2019, says Dr. Beleznay, who tells us that the sale of hyaluron pens is also restricted in Europe. Beyond warning citizens of the dangers involved, Health Canada requested that importers, distributors, and manufacturers of hyaluron pens "stop selling these devices, in addition to asking all companies involved to recall the devices on the market," according to the agency's safety alert.

When we asked Simson if the U.S. FDA was taking steps to remove these devices from the market or to prohibit manufacturers from marketing them for cosmetic use, she replied, "As a policy matter, the FDA does not discuss the regulatory status of specific products except with the firms that are responsible for such products. However, to date, no needleless injector has been approved for the injection of hyaluronic acid for aesthetic purposes."

It's hard to imagine the hyaluron pen ever gaining FDA clearance, considering the litany of risks outlined by our medical experts and the current absence of data on the DIY devices. "If anyone wanted to legitimize these pens, we'd have to have controlled studies — head-to-head against needle injection — to [assess] the safety, efficacy, reliability, and short- and long-term consequences," Dr. Sundaram points out.

While optimistically awaiting hyaluron-pen legislation here in the U.S., we at Allure implore you to heed our experts' warnings and not succumb to social media's latest bad idea.

Additional reporting by Marci Robin.

Leave a Comment