Update (October 13, 2021): The U.S. Food and Drug Administration has issued a safety newsletter in response to injuries caused by injecting fillers with devices such as hyaluronic acid pens. The October 8 statement was addressed to consumers and medical professionals and warned them of the risks associated with these unapproved tools, which have recently become popular on social media, and comment on what should and should not be done with dermal fillers. Suggested what to do.
“The U.S. Food and Drug Administration (FDA) warns the public and healthcare professionals not to use needle-free devices such as hyaluronic acid pens to inject hyaluronic acid (HA) or other lip and facial fillers, collectively referred to as dermal fillers or Fillers,” these devices were mentioned in the statement, and the agency said they use high pressure to force fillers and other substances into the body. “The FDA is aware that using a needle-free device to inject lip and facial fillers can cause serious injury and, in some cases, permanent damage to the skin, lips, or eyes.”
Among the recommendations for consumers, the FDA recommends not to use needle-free devices for any filling procedures, not to buy or use fillers sold directly to the public (because they are for prescription use only), and not to inject yourself or others who use any filling procedures. The device performs lip and face filling. For health professionals, FDA recommendations include not using needle-free injection devices to perform any cosmetic filling procedures, not transferring FDA-approved dermal fillers to needle-free injection devices, and injectable fillings that do not use non-FDA-approved dermal fillers剂产品。 Agent products.
“The FDA is aware that needle-free devices and the lip and facial fillers used with these devices are sold directly to the public online and promote their use on social media to increase lip volume, improve the appearance of wrinkles, and change the nose. The shape and other similar procedures,” the statement read, adding that FDA-approved dermal fillers can only be used with syringes with needles or cannulas. “Needle-free injection devices used for cosmetic purposes cannot provide sufficient control over the placement of injected products. Lip and face filling products sold directly to consumers online may be contaminated with chemicals or infectious organisms.”
The FDA stated that the risks include bleeding or bruising; bacterial, fungal or viral infections from fillers or needle-free devices; disease transmission between people using the same needle-free device; clogged blood vessels leading to tissue death, blindness or stroke; scars; The pressure of the needle-free device causes damage to the eyes; formation of lumps on the skin; skin discoloration; and allergic reactions. The agency is monitoring reports of side effects and added that it is prohibited to sell prescription medical devices without a prescription and may be subject to civil or criminal penalties.
In addition to immediately seeking care from a licensed healthcare provider in the event that the use of needle-free devices such as hyaluronic acid pens cause adverse reactions, the FDA also urges to contact MedWatch, the agency’s safety information and adverse event reporting program to report issues.
Last spring, in the first few days of the pandemic, the stay-at-home order remained in effect, non-essential services were suspended, and DIY took on a whole new meaning. When masks are scarce, we use retired denim and unworn scarves to make our own. When the school was closed, we changed clothes for the teacher and cleverly played with the many platforms needed to educate first-graders on the sofa. We bake our own bread. Paint our own walls. Take care of our own garden.
Perhaps the most dramatic change has taken place in the traditionally service-oriented field of beauty, because people have learned to cut their own hair and do isolation manicures by themselves. The most extreme are those who perform DIY skin treatments, such as mole removal (wrong on many levels), and even more heinously filler injections-even though dermatologists and plastic surgeons are almost back in business , But this trend still exists for a year.
Promoting this movement, TikTok and YouTube have become unfiltered operation centers for hobbyists who want to inject hyaluronic acid (HA) into their lips, nose, and chin using an easily available gadget called a hyaluronic acid pen.
These needle-free devices are available via the Internet and use air pressure to push hyaluronic acid into the skin. Compared with the needles and cannulas used by doctors to inject fillers, hyaluronic acid pens have less control over the speed and depth of HA delivery. “This is an uncontrolled, uncalibrated pressure, so you can actually get different levels of pressure depending on the press,” said Zaki Taher, MD, a board-certified dermatologist in Alberta, Canada .
And there are big differences between brands. In YouTube and TikTok videos, some of the hyaluronic acid pens we investigated appeared to deposit the product on the lips and seemed too weak to pierce the skin (assuming they were used properly). Others received reviews warning of their strength and advised shoppers not to use them on any area of the face.
In most cases, these pens often appear in online reviews-prices range from about $50 to a few hundred dollars-claim to be able to penetrate about 5 to 18 millimeters deep, and at a cost of about 1,000 to 5,000 pounds per square Intensity emission inches (PSI). Hema Sundaram, MD, a board-certified dermatologist in Fairfax, Virginia, said: “From the right perspective, the average pressure on the face is estimated to be 65 to 80 PSI, and the power of a bullet 1,000 PSI and above.” and Rockville, Maryland. However, most of these devices guarantee a painless experience in some way.
The Hyaluron pen is modeled after a hand-held jet syringe, which can inject liquid medicines (such as insulin and anesthetics) into the skin without a needle. “About 20 years ago, I was introduced to these [type of] devices,” said L. Mike Nayak, MD, a board-certified facial plastic surgeon in Frontenac, Missouri, who recently lashed out on Instagram Hyaluronic acid pen. “There is a pen for local anesthesia [it is] the same thing, a spring-loaded device-you pull out lidocaine, press the trigger, and it will produce very fast flowing droplets. They can be so Quickly penetrate the surface of the skin.”
Today, the U.S. Food and Drug Administration (FDA) has approved a handful of jet syringes for very specific drugs—for example, one approved for injections of specific flu vaccines—and interestingly, some of them are hyaluronic acid-pens The predecessors provided early evidence of what our experts call the inherent problems with this type of tool. “Research reports on vaccine intradermal syringes indicate that it is difficult to consistently control the depth and location of the injection [and] the injection site usually causes additional bruising and swelling during needle injection,” said Alex R. Thiersch. A lawyer representing the beauty industry and the founder of the Med Spa Association of America.
Although there are similarities between medical jet syringes and cosmetic hyaluronic acid pens, FDA spokesperson Shirley Simson assured us that “to date, the FDA has not approved needle-free syringes for the injection of hyaluronic acid.” In addition, she pointed out that “only licensed healthcare providers have approved the use of needles or cannula for dermal fillers in some cases. No dermal filler products are approved for use by patients or at home.”
Fans of hyaluronic acid pens might argue that if certain drugs, such as epinephrine and insulin, are considered safe for DIY injections, why not HA? But in those medically acceptable situations, Dr. Nayak explained, “You were given a needle, you were given a syringe, you were given an insulin-and then you got the guidance of a medical professional who was monitoring [process ].” With HA, the hyaluronic acid pen is not approved by the FDA; zero supervision; and you usually target the face, because of its vascular system, the injection is more dangerous than the thigh or shoulder. In addition, Dr. Nayak added that because “people using these pens cannot [legally] buy FDA-approved fillers, they are buying black market fillers online.”
In fact, a recent study published in the journal Dermatologic Surgery found that counterfeit fillers are a common problem, with 41.1% of the doctors surveyed having encountered untested and unverified injections, and 39.7% of doctors Have treated patients with adverse events caused by injections. Another paper published in the Journal of the American Academy of Dermatology in 2020 also mentioned the increase in unregulated Internet injections and the “increasing trend of self-injection of unregulated neurotoxins and fillers under the guidance of YouTube tutorials “.
Katie Beleznay, MD, a board-certified dermatologist in Vancouver, British Columbia, said: “People are very worried about what people put in these pens.” “About the sterility and stability of [online fillers] There are many problems with life expectancy.” Unlike HA that is routinely injected by dermatologists and plastic surgeons certified by the committee, “These products have not undergone strict safety reviews by the FDA, so consumers cannot know what they are injecting,” the committee said. Sarmela Sunder, MD, added. -Certified facial plastic surgeon in Beverly Hills. And because ordinary patients are unlikely to adapt to the differences between different HAs—how their viscosity and elasticity determine proper use and placement, or how their unique cross-linking affects swelling and durability—how do they know which gels are actually Will there be a pen or the most natural-looking lips or tears or cheeks?
In the past few months, dozens of board-certified dermatologists and plastic surgeons have warned their followers on social media about the myriad risks associated with hyaluronic acid pens and DIY filler injections in general. .
Leading the charge is the American Society of Dermatological Surgery (ASDS). In February, the organization issued a patient safety alert and stated in a statement that they had contacted the FDA regarding the safety of the hyaluronic acid pen phenomenon. In March of this year, the American Academy of Dermatology issued a similar statement, warning that “although it may be tempting to inject hyaluronic acid fillers purchased online into the face or lips using a needle-free’do-it-yourself’ device, but to do so It may have serious health consequences.”
Although filler complications can occur even for the most experienced injectors, FDA-approved hyaluronic acid fillers, such as Juvéderm, Restylane, and Belotero, are certified by a qualified board of dermatologists and understand anatomy and plastic surgery The doctor’s needle or cannula is considered very safe for injection. If complications occur, they can be identified and reversed. “Bulkers are a great treatment-they are very popular and [have] very high satisfaction-but you have to know what you are doing,” ASDS president and board-certified Boston dermatologist Mathew Avram The MD reiterated, “They are dangerous if they are injected into the wrong area-there are reports of blindness, stroke and [skin] ulcers that can disfigure the appearance.”
Usually, the “wrong area” is difficult to distinguish from the correct area. Dr. Nayak said: “A small part in the right direction or in the wrong direction is the difference between a large part of your lips and nose with loops or no loops.” He added that given the insufficient accuracy of pen reports, “even if I have [one], and I will never consider using it to inject fillers because I am afraid that I cannot control the actual whereabouts of the product.” (The recent failure of the hyaluronic acid pen treated by Dr. Nayak’s team is what he called ” An example of the “best-worst-case scenario”, which may be caused by the unstable product delivery of the device: the obvious filler BB is spread on the surface of the patient’s lips.)
Although countless companies produce hyaluronic acid pens, and there seem to be subtle differences between the models-mainly related to the depth of delivery and pressure and speed measurements in the advertisement-our experts insist that they are mainly operated by the same mechanical means And bring similar risks. “These pens are worrying, and I don’t think I commented that any [one] of these pens is definitely better than the other, and it is unethical for people who have no medical training and are very familiar with facial anatomy,” Dr. Sander Say.
It is for this that the basic DIY nature of these devices makes them so dangerous—in fact, they are “sold to individuals who are not eligible for filler injections and instigate self-treatment,” Dr. Sundaram added.
The lure asked Dr. Sunder, Dr. Sundaram, and Dr. Kavita Mariwalla, MD to evaluate some hyaluronic acid pens seen on social media. As expected, the absence of needles does not mean that there are no problems: hyaluronic acid pens can threaten our health and appearance in several important ways.
When the gel invades or compresses the arteries, blocks blood flow and may cause skin peeling, blindness or stroke, vascular occlusion occurs-the most terrible filling complication. “Vascular damage is always a problem with any filler injection, no matter how the filler is introduced into the body,” said Dr. Sander. “Although some pen proponents [on social media] believe that the pen cannot penetrate blood vessels like a needle, so [it] is unlikely to cause a vascular event, there is still a significant risk of vascular damage due to the compression of the filler by the container.”
Dr. Taher witnessed vascular occlusion caused by DIY injection with hyaluronic acid pen. “The situation I encountered-she was a real vascular crisis,” he said. “I saw a photo and said,’You must come in right away.’” On the patient’s upper lip, he recognized the iconic purple discoloration of the vascular occlusion that needed to be reversed (you can see it here, in PSA. Post on YouTube after treatment). Through two rounds of an injectable enzyme called hyaluronidase, he was able to dissolve the clot and save the patient’s skin.
Several key facial arteries run only a few millimeters below the surface of the skin. Dr. Sundaram pointed out that TikToker users who use a lot of hyaluronic acid pens for lip enhancement may not realize that “[supplying upper and lower lips] lip arteries may be very close to the skin surface,” especially in more mature skin, as they age And become thinner. “At certain points of the lower lip, ultrasound imaging revealed that the depth of the arteries below the skin surface was in the range of 1.8 to 5.8 mm,” she added. In the same study, the depth of the artery that nourishes the upper lip ranged from 3.1 to 5.1 mm. “Therefore, the HA pressurized jet from the hyaluronic acid pen must be able to contact the upper lip artery, the lower lip artery and other important structures,” Dr. Sundaram concluded.
When viewing an HA pen tutorial on YouTube, Dr. Sundaram was frustrated to see the company’s reply telling the reviewer “Yes, you can use the pen to treat temples,” but it’s best to consult a doctor for the correct technique. According to Dr. Sundaram, “In terms of blindness caused by filler injection, the temple is an important risk area of the face because the blood vessels in the temple are connected to the blood vessels that supply the eyes. The main artery of the temple, the superficial temporal artery, is Running inside the fibrous tissue under the skin, the fat layer in this area is thinner,” making it easy to block, especially if the syringe does not know where it is.
“The pressure injection is actually zero on the face,” Mariwalla said. In order to minimize complications such as vascular occlusion and common bruises, “We always teach the doctor to inject slowly at low pressure.”
However, the hyaluronic acid pen relies on powerful force and speed to deliver the filler into the skin. “When the device does not have a needle as an entry point, the product basically needs to be pushed under such a high pressure that it can tear or tear the skin,” said Dr. Sander. In the case of lip injection, “every time significant pressure is applied to the sensitive mucosa, it will cause trauma and crush injury to a certain extent-[and] not only the skin, but also the underlying blood vessels, such as many [ Hyaluronic acid pen] Bruises in the video of the operation prove this. Due to mucosal damage, the high pressure introduced into the product may lead to long-term scar formation.”
Dr. Sundaram compares HA injections with hyaluronic acid pens to “filled bullets” and compares the trauma they produce with the collateral damage caused when the actual bullets are shot into human tissues. “Common sense tells us that if you push a high-speed bullet into the skin under extreme air pressure, it will cause tissue trauma.”
“These pens cannot provide controlled and predictable treatment,” Dr. Sundaram said, “because forcing the filler into the skin under high pressure can cause it to spread unpredictably and inconsistently.” In addition, she pointed out that once the skin is in The swelling started during the treatment, “The swelling will obscure the true shape of the lips-as far as where you put these things, you no longer have any accuracy.”
She recently treated a hyaluronic acid pen user who had “the upper lip is much larger than the lower lip, and then one side of the upper lip was significantly larger than the other side, and it was bruised and lumpy,” she said.
Dr. Sundaram also pointed out that a pen with a large advertising depth can touch certain muscles, such as the muscles that move the mouth. “Ultrasound scans of the lips of a living body-more accurate than cadaver studies-indicate that the orbicularis oris is about 4 millimeters below the surface of the skin,” she explained. If the hyaluronic acid pen deposits fillers into the muscles, “its fluidity may cause an increased risk of filler clumps and lumps, and even further displacement of the filler-often erroneously referred to as’migration’,” she says.
On the other hand, if certain HAs—the strong, plump varieties—are injected too shallowly with unpredictable pens, they can also cause problems, such as visible bumps and blue tints. “Some of the fillers touted for [the pens] are actually thicker and more crosslinked,” said Dr. Sundaram. “If you inject these on the surface, you will get the Tyndall effect, [this is a] blue discoloration caused by light scattering.”
In addition to the pen’s problematic depth and dispersion pattern, “the fact that [they implanted] products as a single pill or warehouse, rather than a linear placement of continuous movement, is a problem from a safety and aesthetic point of view. “Dr. Sand said. “The experienced syringe never stores the product, especially on the lips.”
Mariwalla co-signed: “I never [use] continuous bolus injection technique to inject the lips-it not only looks unnatural, but the patient feels lumps and bumps.” Dr. Sunder pointed out that the bolus injection also increases “vascular The risk of damage or tissue damage.
The danger here comes from two sources-the uncertain substance injected and the hyaluronic acid pen itself.
As mentioned earlier, “perhaps the most worrying of all the problems is the actual filler itself,” said Dr. Sander. In addition to the possibility of contamination or adulteration, “I also worry that some laymen may not understand the nuances between hyaluronic acid used for topical use [such as serum] and the real hyaluronic acid filler used for injection. Will The introduction of topical products into the skin or the mucous membranes of these pens may cause long-term complications such as foreign body reactions or granuloma formation,” which may be difficult to correct.
Even if someone somehow manages to obtain a pure, legal HA filler, putting it in a pen will open another can of worms. “[They] need to transfer the filler from their original syringe to the ampoule in the pen,” Dr. Sundaram pointed out. “This is a multi-step process—connect the transfer syringe to the needle, draw the filler, and spray it into the ampoule—every time it’s done, there’s a risk of contamination.”
Dr. Sunder added, “Even if this operation is performed in a medical environment, the transfer will not be sterile. But performing this operation in a person’s home is a preparation for infection.”
Then there is the issue of DIY disinfection. “Each pen has removable parts. The question is, how clean is the actual device itself?” Mariwala said. “These companies want you to inject a material from unknown and stable sources into your skin. How about a device with a ridge and a part that should be cleaned? Use soap and water and dry it on the dishwasher? It doesn’t seem to be. Security to me.”
Dr. Sundaram said that since most people except medical staff are not familiar with the complexity of aseptic technique, “it is very likely that patients will eventually use non-sterile HA and push it into the skin.”
Dr. Beleznay said that the Canadian health authorities issued a public safety warning for these pens in 2019. As an example of feasible measures to protect the public from self-harm, he told us that the sales of hyaluronic acid pens are also restricted in Europe. According to the agency’s security alert, in addition to warning citizens of the dangers involved, Health Canada also requires importers, distributors, and manufacturers of hyaluronic acid pens to “stop selling these devices and require all relevant companies to recall those on the market. equipment”.
When we asked Simson if the US FDA is taking steps to withdraw these devices from the market or prohibit manufacturers from marketing them for cosmetics, she replied: “As a matter of policy, the FDA does not discuss the regulatory status of specific products unless it is The companies responsible for such products cooperate. However, to date, no needle-free syringe has been approved for injection of hyaluronic acid for cosmetic purposes.”
Considering the series of risks outlined by our medical experts and the current lack of data on DIY equipment, it is hard to imagine that the hyaluronic acid pen will be approved by the FDA. “If someone wants to legalize these pens, we must conduct a controlled study-head-to-head needle injection-to [evaluate] safety, effectiveness, reliability, and short-term and long-term consequences,” said the doctor. Sundaram pointed out.
While optimistically waiting for the US hyaluronic acid pen legislation, we at Allure urge you to heed the warnings of our experts and do not succumb to the latest bad ideas on social media. Additional reporting by Marci Robin.
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Post time: Dec-14-2021