In recent months there has been a rise in botched DIY lip fillers. This DIY “lip filler” trend started a few years ago when people were trying the Kylie Jenner Lip Challenge in which people would insert their lips into a shot glass or other suction cup type tool, suck, and wait for their lips to swell up to an extremely unsettling plump. This challenge resulted in various injuries, heavy bruising and severe swelling.
While there are quite a few methods used for people to achieve a bit of a plump without needing the injections, such as a quality lip plumping balms that involve nothing more than a few harmless ingredients such as capsaicin to slightly irritate your lips, in recent years people have been opting for more extreme measures to enhance the size of their lips at home or at clinics that offer a non invasive lip filler approach – the hyaluron pen.
During the Coronavirus pandemic, people were stuck inside, forced to do a lot of things for themselves. This included cooking, baking, hair cuts, nails, and more. It seems that being in lockdown influenced some people to take drastic measures to maintain the appearance that they had been used to, to the point that people were doing their own personal mole removals and as this article suggests, DIY cosmetic treatments. While most professionals are back in business at this time, this trend continued to grow, expanding over various social media platforms with video tutorials on how to give yourself a lip filler. While observing one of the YouTube tutorials on how to use a hyaluron pen, Dr. Schwarzburg, owner of a popular medical spa located on the Upper East Side of Manhattan, Skinly Aesthetics, was disconcerted at the unprofessional manner and misleading information that the aesthetician in the video was sharing with her audience.
The hyaluron pen can be easily purchased online and is available at certain non-medical day spas that advertise the treatment as a non-invasive and safer alternative to a traditional injectable lip filler. Unfortunately consumer reports and emergency room visits prove otherwise, as there have been increasingly negative reviews and complaints on the treatment and its results, in addition to an official warning by the FDA to avoid these needle-free devices stating that “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.”
Due to the rise in reports of botched lips secondary to hyaluron pen treatments, there has been a lot of buzz on the treatment, giving the whole idea of the hyaluron pen bad press. The hyaluron pen has been used on other areas including the forehead, nasolabial folds (also called smile lines), marionette lines, and frown lines between the eyebrows, though the most frequently spoken about treatment area, especially when it comes to the buzz about botched results, remain to be the lips.
Below is a detailed description of what the hyaluron pen is, how it works, and why the FDA and countless physicians warn against it.
Let’s start with the real deal
Before we start going over all the details involved in the hyaluron pen, let’s discuss the original treatment: injectable lip fillers. How do lip fillers work? What are the pros and cons, and how much do they cost?
The first equivalent to modern injectable lip fillers was invented at the beginning of the 19th century and consisted of injectable fat, also called fat grafting. While this treatment was originally intended to reshape uneven lips caused by tuberculosis, it triggered a long path of trial and error leading to the injectable lip fillers we have today. You may still find some clinics that offer a fat transfer to the lips, however, due to its unreliable results that often end up migrating, lumping, and settling unevenly, it is typically no longer a common practice.
In the 1960s, liquid silicone began to make its mark in the world of cosmetic enhancements, but was disapproved by the FDA fairly quickly (in the 1990s) due to the adverse effects associated with the injection of liquid silicone, including severe pain, scarring, tissue death, permanent disfigurement, silicone embolism, and sometimes even death. Keep in mind that nothing has to be FDA approved in order to still be legal, meaning that liquid silicone injections are still available in select clinics, though the injection of liquid silicone is heavily frowned upon by most medical professionals.
Today, the global gold standard for dermal fillers in the lips are hyaluronic acid based dermal fillers. They have been approved by European regulators in the late 1990s, but only saw first FDA approval in April, 2004.
What makes hyaluronic acid based lip fillers injected through a needle or a cannula the gold standard? They are the safest type of filler you can get, and here’s why:
- They are biocompatible. Hyaluronic acid is a naturally lubricating and hydrating substance found in our joints to make movement along various upper and lower body joints a seamless process. This means that the risk of allergy or rejection is essentially nonexistent than if someone was to be injected with an unnatural substance like polymethyl-methacrylate microspheres (main ingredient in Bellafill filler), which would require allergy testing prior to an injection.
- They are reversible. Hyaluronic acid based dermal fillers are reversible, using hyaluronidase injections, which break up hyaluronic acid and immediately dissolve the dermal filler, reversing your lips back to their original form. This becomes a critical aspect in the event of an inadvertent intravascular injection resulting in vascular occlusion. Non-hyaluronic based dermal fillers currently have no agent for reversal.
- There are multiple varieties of Hyaluronic Acid based fillers. While Juvederm is the most universally known hyaluronic acid based filler, there are numerous other brands of hyaluronic acid based dermal fillers, each of which is slightly different from the other. This allows physicians to tailor the fillers to each patient’s anatomy and desired results. Currently FDA approved hyaluronic acid fillers on US market include brands like Juvederm, Restylane, Belotero, Revanesse and Teosyal. Each of these families of fillers come are further subdivided into various types, which are specifically designed for different purposes and treatment areas. This allows the injector to choose from a variety of biomolecular properties and formulations that will best suit the individual patient, rather than having to use a “one size fits all” type approach.
- Their production is standardized. The manufacturing process of all hyaluronic acid based fillers are standardized, making them safe and predictable. All facilities producing fillers must comply with stringent GMP standards and are subject to annual inspections to ensure quality and safety of hyaluronic acid gels.
- Easy administration for physicians. Hyaluronic acid based dermal fillers are easier to inject and administer than other fillers due to their predetermined viscoelastic properties and their density, allowing the injections to be more precise during the treatment, which also results in a better, more individualized outcome for each patient. The viscoelastic properties are sometimes expressed as G prime factor, which is essentially defines the elasticity of the fillers and their ability to retain shape when a certain force is applied.
- A filler with a high G prime is a firmer gel allowing to define a specific shape owning to their rigidity. Juvederm Voluma or Restylane Lyft are prime examples and may be used in someone with thinner lips as the rigidity of the gel will allow to maintain newly established structure and shape of the lips.
- A filler with a low G prime is a softer and more fluid gel making the enhancement more subtle and less noticeable.
- High reproducibility and longevity. When physicians know the rheological properties of fillers and how they behave in tissues when injected it is easier to predict the expected outcomes. Some fillers are already fully hydrated meaning that they achieved their maximal expansion, when loaded in the syringe. Such fillers will produce minimal swelling after injection because their hydrophilic ability is maxed out at the stage of manufacturing. RHA family by Teosyal and Juvederm Volbella are classic examples. Other fillers like Juvederm Ultra or Juvederm Ultra Plus are partially hydrated and may cause substantial initial swelling upon injection as they attract and incorporate extracellular fluid into the gel matrix. Knowing these parameters is crucial to guide patients’ expectations and post-injection recovery. Most of the fillers are also manufactured using advanced crosslinking technology, which makes them resistant to degradation allowing for a predictable duration of the results.
While hyaluronic acid based fillers are the best and safest dermal fillers used to inject the lips, the method used to plump people’s lips with hyaluronic acid using the hyaluron pen, is completely different. The short of the long: traditional lip injections are skillfully injected using a sharp, thin and hollow needle or a blunt cannula utilizing various techniques. This approach permits a precise and thought out look that matches the patient’s lips and meets their individual needs. Through various clinical studies it has been established that the only way to safely deliver a filler for aesthetically pleasing results involves introduction of the needle or cannula under the skin to deposit the filler in a specific way or fashion. While minor bruising is one of most common side effects it is very transient in nature without any long term health related consequences.
The hyaluron pen works by forcefully pressing an unknown type of hyaluronic acid into the lips with an immense amount of pressure, making it a needleless lip filler. To make more sense of how much pressure is being used for this treatment, you can compare it to that of a car tire, where the normal pressure is maintained at 32 – 35 pounds per square inch (PSI). The pressure used for the hyaluron pen is a shocking minimum of 1000 PSI. These types of injectors are FDA approved for the administration of certain drugs, such as flu vaccines and insulin, not for the injection of hyaluronic acid or any other dermal fillers. Similar tools such as FlexPens and SoloStar pens have been used for decades to deliver insulin, anesthesia, and other liquid medications to the body without having to use a needle, and work through a spring-loaded device to trigger quick bursts of fluid droplets directly through the skin.
Continue reading for an in depth discussion about the hyaluron pen, how it works, and why so many doctors warn against it.
What is a DIY lip filler?
A DIY or “do it yourself” filler is exactly what it sounds like: a lip filler that doesn’t require a trained medical professional to administer it. This sounds convenient, but how can you get a dermal filler into your lips without the help of a medical professional when you don’t know how to properly inject it? You don’t. The hyaluron pen gets the dermal filler into your lips not through a needle or cannula injection, but through the use of extreme pressure, which can not only be incredibly painful, but also completely imprecise. Solely using pressure to press filler into your lips requires no precision at all, which also leads to messy, but more importantly dangerous results. It turns out that the various brands of hyaluron pens reviewed by TikTok users, YouTubers, and other social media influencers also have different levels of pressure. While some of them seemed to have been too weak to pierce through the skin, leaving the user with the content of the pen on their lips, others warned against certain brands due to the intensity and painful process.
When comparing the hyaluron pen to a traditional lip filler injection, the hyaluron pen is advertised to be a method that allows for a more even result, as it spreads the hyaluronic acid evenly throughout the treatment area. As mentioned above, the force used in these pens is shockingly high (1,000 to 5,000 PSI), penetrating the skin up to 18 millimeters deep. Another comparison to help you understand the amount of force used with this tool, is to the force of an average punch, which is approximately 65 to 80 PSI, while the force of a bullet is a minimum of 1,000 PSI, and the force of a hyaluron pen can be up to a whopping 5,000 PSI, though hyaluron pen companies promise a painless experience.
What the hyaluron pen claims to do:
- Hyaluronic acid is absorbed and distributed better than with a needle;
- Hyaluronic acid turns into nanoscale molecules and inserts the filler through the microchannels in the skin;
- Makes the skin appear more plump and supple;
- Creates volume, shape, lift in lips, nasolabial folds, marionette lines, forehead wrinkles, and more;
- Controls the amount of hyarlonic acid to be injected to avoid complications and removes the risk of incorrect sterilization of needles;
- Needle free, non invasive, safe
So what are the true dangers of the hyaluron pen?
While the hyaluron pen has been advertised as a safe and effective alternative to traditional injectable lip fillers, it turns out that the majority of patients are disappointed in their results. Some of the main side effects reported with this treatment were inflammatory skin reactions including small white bumps, discoloration and hyperpigmentation of the skin, as well as fungal and bacterial infections. Because the product is simply pressed into the treatment area, there is no control of how and where the filler is placed, leaving many patients with bumps and lumps around their lips and other areas in which they have used the hyaluron pen.
Such dangers were already well known to physicians having used hyaluron pen predecessors, who confirm that using hyaluron pen-like devices have proven to be inconsistent when it came to control and depth of the medication to be administered, and frequently resulted in more bruising and swelling than the traditional needle injection.
These recurring side effects were reported to the FDA, which led to a formal warning in October of 2021 against the use of “needle-free devices for injection of dermal fillers”.
According to the FDA, risks included in needle free dermal fillers include:
- Bleeding or bruising (pressure on the mucosa will inevitably cause trauma and injury to the skin as well as underlying blood vessels, which will result in bleeding and bruising)
- Infection or allergic reaction (aside from the possibility of the dermal filler sold on the black market for hyaluron pens being contaminated, pumping any product that isn’t designed for injectable or internal use into the skin or mucosa is likely to cause long term negative effects including granulomas and reactions to forein substances in the body)
- Transmission of disease (since one device is used, rather than a fresh sterile needle with each patient)
- Vascular occlusion (blockage of a blood vessel, which can lead to tissue death, blindness, or stroke): one of the most dangerous complications associated with fillers which is classified by a gel compressing an artery or blocking a blood vessel, leading to tissue death, blindness, and / or stroke. Due to the many critical arteries right below the surface of the skin of the lips, hyaluron pens pose a dangerous threat as they emit such high pressure into that exact area.
- Swelling, lumps, bumps, scarring, and permanent disfiguration (High pressure filler being pumped into your lips with incredibly high force will lead to unpredictable distribution of filler. In addition the force will cause bruising, regardless of where the filler is distributed)
- Discoloration and hyperpigmentation
- Damage to the eyes due to pressure of the pen
When using the hyaluron pen for needle-free lip fillers, many users do not understand the true anatomy that lies beneath the lips. There are numerous critical arteries that are present only millimeters beneath the surface of the skin, including the labial arteries, which are responsible for the blood supply of the upper and lower lips. These labial arteries can range from 1.8 to 5.8 millimeters below the surface of the skin, making them incredibly shallow and puts them at high risk for rupture and occlusion with the use of a hyaluron pen. The artery supplying the upper lip ranges 3.1 to 5.1 millimeters in depth, meaning that the hyaluron pen, which can penetrate up to 18 millimeters below the surface of the skin, is a huge threat to these fine yet vital arteries. Damage to these arteries can cause the severe complications listed above, making the hyaluron pen a dangerous tool to be used in such delicate areas.
Aside from the side effects associated with the treatment itself, the FDA also explains that the filler substances which are sold individually apart from the device used, may not even contain hyaluronic acids, meaning that you could be pressing literally anything, including harmful chemicals into your face. Because the people using hyaluron pens are typically unable to purchase true lip fillers, their fillers are coming from the black market, which, needless to say, is unreliable and unsafe.
The FDA stresses that neither FDA approved nor FDA unapproved dermal fillers should be transferred to a needle free device, as FDA approved dermal fillers are strictly intended to be used with a needle by a trained medical professional, not by the patient at home. While such tools are used in controlled situations and only when prescribed by a physician, hyaluron pens are not prescribed by a physician, or FDA approved for cosmetic purposes.
The fillers typically come from overseas where they have different regulations and manufacturing practices, and based on customer descriptions, the ingredients are never listed in English, meaning that most people in the U.S. have no idea what they are actually putting into their faces when using this tool. In fact, it was found that many physicians have encountered untested and unverified dermal fillers, resulting in adverse side effects in their patients. If even physicians are sometimes confronted with counterfeit fillers, imagine how many black market fillers are out there and available to the general population.
Another thing that is terrifying about this is that anyone can purchase it online and do it themselves at home without any medical background whatsoever. Instead, people are taking phony classes in apartments led by untrained and uncertified scammers to learn how to administer the treatment, which based on reviews and results (even if administered by medical professionals) have proven to be nearly impossible.
The American Med Spa Association warns that even though this treatment is legal and does not involve needles, the skin is still being pierced by the product, which means that at the very least it should be administered by a trained medical professional.
In the case that someone does experience any adverse side effects after using or getting treated with a needle-free lip filler, the FDA encourages users to report any issues to MedWatch, the FDA’s Safety Information and Adverse Event Reporting program.
How much it costs:
The cost of the hyaluron pen ranges $100 to $500 depending on where you get it and what package you get. If you get a DIY kit that comes with lidocaine, filler, and the pen, the cost may be on the higher end of that scale. The pen itself can be purchased for as little as $99, with tiny filler cartridges that can be purchased for only $16. If you go to a clinic, the average cost is about $300 per session, and is said to last 6 – 12 months once two sessions are completed.
Are there any benefits to the hyaluron pen?
Hypothetically speaking, the benefits involved in the hyaluron pen include:
- Needle free
- Non invasive
- Cost efficient
- Easy administration (DIY)
However, if these were benefits that everyone went by without considering the dangers involved, we could also all be rubbing bleach on our faces to help eliminate hyperpigmentation. Fortunately the word has spread about all the dangers involved in this DIY needle free filler, and while it is not illegal, it seems that it is slowly decreasing in popularity as more and more people are starting to worry that such drastic side effects will happen to them.
I still don’t want a traditional filler, what can I do instead?
While traditional injectable lip fillers are completely safe as long as they are performed by a trained and skilled medical professional, a lot of people still don’t want to get them due to fear of needles, or other reasons. Here are a few minimally invasive and non-invasive alternatives to an injectable hyaluronic acid lip filler that are both safe and effective.
- Lip flip: Botox lip flip is a minimally invasive mini lip enhancement that involves the injection of a neurotoxin right above the lip. This causes the lip to flip upward, creating a plumper looking pout. While this method is still an injectable, it does not physically add more volume to your lips. Instead, it creates the illusion of a slightly larger top lip. The cost of a lip flip can range anywhere from $120 – 300, making it an affordable and subtle alternative to a traditional lip filler.
- Lip plumping balms: Lip plumpers are completely non-invasive and can be found in almost any pharmacy or beauty store. Lip plumpers have been around for a long time and work to plump your lips temporarily (about 20 minutes) by slightly irritating your lips due to ingredients such as capacisin and peppermint.
- Lip scrubs: Lip scrubs can give you a temporary plump by exfoliating your lips and causing mild swelling in the process. While you should be careful as this can dry out your lips (so be sure to apply plenty of moisturizer after), it is generally safe as long as you don’t scrub too hard and will give you a temporary plump.
- Stay hydrated: You may have noticed a difference between the size of your lips before and after you apply some lip balm to your dry lips. When our lips are dry, they tend to look smaller and lose their brightness. Try to stay hydrated and moisturize your lips to keep them fresh and naturally plump.
DIY lip fillers summed up:
The hyaluron pen has been advertised as a safe and effective alternative method to fill your lips with hyaluronic acid without using the traditional technique of injections. After multiple botched outcomes and bad reviews, the FDA released a warning to avoid this dangerous needle free filler due to it’s array of possible risks and side effects, including bruising, swelling, lumps, bumps, clogged blood vessels, and more serious side effects including tissue necrosis. The hyaluron pen is not approved by the FDA, but is legally sold online and by certain providers at some day spas. People can administer the treatment on themselves at home, and are even offered courses online and in people’s personal homes by untrained individuals with no medical experience.
In order to avoid such serious side effects and all the risks involved in this treatment, if you want to enhance the size of your lips without getting a traditional dermal filler injected, there are other options safer than the hyaluron pen, such as a lip flip, lip plumpers, lip scrubs, and simple natural methods such as keeping your lips hydrated.