By Alex R. Thiersch, JD, CEO of the American Med Spa Association (AmSpa)

Update October 11, 2021: The FDA has issued a safety communication regarding the use of needle-free devices for the injection of dermal fillers. The following is an excerpt:

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 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.

Recommendations for Health Care Providers:

• Be aware that needle-free devices for injection of dermal fillers are not approved by the FDA.
  
• Do not perform any aesthetic filler procedures with needle-free injection devices.
  
• Do not use injectable filler products that are not FDA-approved dermal fillers.
  
• Do not transfer FDA-approved dermal fillers into needle-free injection devices.
  
• Be aware that FDA-approved dermal fillers are supplied by prescription for injection by a licensed health care provider using a syringe with a needle or cannula.
  
• If you encounter a patient who has experienced adverse effects from a procedure that involves the use of needle-free devices to inject fillers, please consider filing a report through the FDA's voluntary reporting webpage, MedWatch, the FDA Safety Information and Adverse Event Reporting program.
  

Read more at U.S. Food & Drug Administration >>

Original Text: In the past several months, you may have noticed an explosion of ads, social media posts, articles, videos and training events talking about an "incredible" new injection device that can place hyaluronic acid filler in the skin without using a needle. These devices are often marketed as "non-invasive" or "non-medical," using names such as "hyaluron pen" or "hyaluronic acid atomizer."

However, make no mistake—just because they do not have needles does not mean these products are not medical devices or that they can be used without risk. On September 13, 2019, the Canadian Department of Health issued a warning regarding these devices. It stated these injectors pose health risks and are not authorized for sale in Canada. In the U.S., while no state has publicly commented on these devices yet, "administering medication," no matter the method used, is part of the definition of each state's "practice of medicine." Therefore, these needle-free injection devices should be treated the same as traditional syringes. People wanting to perform these treatments still need to have the same type of professional license they would need to inject using a needle and syringe, and they will still need to work under the supervision of a physician or another appropriate professional.

No Needle, No Problem?

Needle-free injection devices generally are used to deliver vaccines and medications either intramuscularly or subcutaneously, similar to a traditional needle and syringe. They work by creating a very narrow high-pressure jet of medication that is able to penetrate the skin; the jet is generated using gas or spring pressure to force the medicine through a small opening in a disposable vial. The benefits claimed include lower chances of cross-contamination, reduced needle-stick injuries, and less sharp medical waste. This makes these devices particularly well suited for inoculation campaigns, clinics and home self-administration of insulin or other medication.

Medical devices and substances may not be marketed in the United States without obtaining U.S. Food and Drug Administration (FDA) approval. FDA approved or classified devices may be marketed only for their approved use. For FDA registration, needle-free or jet devices fall into three broad groups:

1. General-purpose injection devices meant to be used for injecting drugs that work in needle-free systems;
2. Devices meant for a certain class of drugs, such as insulin, or use with a specific manufacturer's specific product line—both of these groups are considered class II medical devices; and
3. Devices intended to be marketed with a specific product, either labeled for use or sold together, and therefore treated as a combination device.

The first and second group of injectors are regulated using the premarket notification process under the 510(k) provision. These premarket notifications are granted when a new device is substantially similar to an existing approved device, and they allow the manufacturer to begin marketing the product while it complies with the more lengthy registration and approval process. In order to be cleared in this process, at least one drug or injectable substance must already be approved for this method of injection.

A number of needle-free and jet injectors have these filed premarket notifications with FDA; however, none of the "hyaluronic pens" currently on the market appear to correspond with any of these premarket notifications or be from manufacturers who have applied for one. Additionally, FDA has approved a number of hyaluronic acid-based fillers for injection using the traditional needle and syringe method. Thus far, no hyaluronic acid fillers have been approved for use in needle-free injectors. So, any pen injector under the premarket category would need to be compatible with an approved substance other than hyaluronic acid, and, once approved, could not be marketed for use with hyaluronic acid-based fillers.

The majority of the hyaluronic pens currently listed online are packaged with a supply of hyaluronic acid, which would most likely place them in the third category. Devices in this category are considered combination products and can be marketed for that specific use and product after approval. It does not appear that any of the currently marketed "hyaluronic pens" have any FDA approval for their use as Class II devices meant for general injections, and certainly not specifically for using hyaluronic acid.

On the Up-and-up

While no needle-free devices have been approved for hyaluronic acid, several needle-free injection devices have received FDA approval for use with specific drugs, which is something a properly marketed hyaluronic filler device would need to receive. For example, in 2014, a needle-free injector manufactured by PharmaJet and Seqirus Pty. Ltd.—manufacturer of the influenza vaccine Afluria—received approval to administer the Afluria vaccine using the PharmaJet Stratis injector for patients from 18 to 64 years old. FDA made clear, however, that it still recommends sterile needles and syringes for other vaccines and for patients younger than 18 and older than 64.

FDA approvals for both injectable drugs and injection devices are narrow and specific. In the above example, a pediatric office would be in violation if it advertised this service to its patients, since using it on those under 18 is not approved.

Many of these devices are marketed for at-home personal use and can be purchased through several online retailers. Some issues with the marketing of these devices are discussed above, but there are other issues for those who want to use these devices at home.

Safe and Sound

Surprisingly, there are relatively few legal issues for those wanting to treat themselves. Furthermore, people are generally free to do things for themselves that would normally require a professional license if performed by another—you can cut your own hair without a barber's license, you can write your own contracts without a law license, and you can treat your fever without being a doctor. Similarly, someone can possess a jet injector for their personal use, as well as possess syringes and scalpels if they so choose. It is worth noting, however, that in some states, possessing prescription drugs and substances—such as injectable hyaluronic acid—without a prescription is prohibited. And offering to perform these treatments on others is considered the practice of medicine without a license.

From a practical standpoint, people should think carefully before choosing to perform medical procedures on themselves. The jet injectors being sold are not designed for this use—they appear to be rebranded and repurposed injectors that are not approved in the U.S. The hyaluronic acid fillers sold with them and available online also are not approved for injection into humans and often are of unknown sterility, safety or quality.

Additionally, much like the concept of "cutting hair," the concept of using the pen injector sounds very simple. However, just as successfully giving yourself a haircut is far more complex than it seems, performing injections on yourself more complicated than it might appear. Those wanting to perform these treatments should first discuss the risks and potential complications—such as infection, contamination or vascular occlusion—with their physician.

Professional Considerations

Medical aesthetics professionals may be interested in bringing needle-free devices into their medical spa practice. This creates its own set of questions—namely, can you? And should you? Licensed health care professionals can be subject to professional penalties and discipline on their license if they are found to be using non-FDA-approved medication or devices. However, physicians generally are able to use otherwise-approved devices and drugs in ways that are not yet approved by the FDA. This is commonly known as "off-label use," and it is the source of a great deal of innovation and advancement in the medical field. However, physicians are not allowed to advertise and promote off-label uses. Additionally, using unapproved devices in an unapproved way can create standard-of-care and liability issues for the practitioner if the patient experiences an adverse outcome.

So, while it would not be advisable for a nurse or physician to purchase one of these unapproved, illegally marketed devices off eBay, for example, a physician could take an FDA-approved needle-free injector and repurpose it for injecting FDA-approved fillers, so long as they did not market or advertise this practice. The question then becomes—does it make sense to do this? Do such devices bring additional capabilities over the current syringe-and-needle techniques?

While many of the approved devices allow for the dosage per "firing" to be metered, it does not appear that the placement of the medication can be done as precisely as using a syringe and needle—there is no way to ensure that the filler is injected in the precise location or depth, or in the amount desired. According to studies conducted by jet injector manufacturers, the amount of the drug that is actually delivered and the precise location of delivery can vary from injection to injection. The depth and penetration also can be influenced by tissue density, the angle of the injector to the skin, and the pressure applied against the skin prior to firing.

While these variables can be within acceptable limits for administering vaccines and medicine, would they be acceptable for cosmetic treatments on someone's lips or face? Additionally, in the FDA's Afluria/PharmaJet announcement on August 15, 2014, both the study performed for the approval and two prior needle-free injector studies (Jackson et. al. Vaccine 2001, Simon et. al. Vaccine 2011) found that needle-free injections had a higher rate of pain, redness and swelling at the injection site than those who received traditional hypodermic injections. Newer devices may remedy some of these issues, but any licensed practitioner should carefully consider the pros and cons before integrating this off-label use into their practice.

Taking Your Chances

The current crop of "hyaluronic pen" devices that are unscrupulously and illegally being marketed to the public create many issues, even beyond their lack of FDA approval. The public should be extremely wary about using these devices, and under no circumstances should anyone perform this treatment—or any other cosmetic injectable—unless they hold an appropriate health care professional license or are working under the supervision of a physician. Licensed health care professionals should educate their patients about the risks of these at-home, unapproved products and should always carefully consider the benefits of adding a new or novel treatment to their practice.

In addition to the issues discussed above, there is now substantial additional reason to not use these devices in your practice. Since this article was originally published, the FDA has issued a warning on the use of needle-less injectors citing dangerous complications. Please see the link at the top for additional information on the FDA's website.