FDA Warns Against the Use of Needle-Free Injections for Dermal Fillers

The US Food and Drug Administration (FDA) has issued a safety communication about the use of needle-free devices for dermal fillers. This is in response to the reported injuries associated with their use, including damage to eyes, lips, and skin.

According to the FDA, these devices are marketed as “Hyaluron Pens, Hyla-Pen, microinjectors, noninvasive injection pens, noninvasive nebulizer syringes, high pressure pens or sprayer pens.”

Advice for patients 

This press announcement, which was released on October 8, is addressed to both patients and healthcare providers. “These unapproved needle-free devices and fillers are often sold directly to customers online, bypassing consultation with a licensed health care provider, a critical safety measure for patients to make informed decisions about their personal health”, the statement reads.  

Here is a list of the FDA’s recommendations for consumers: 

  • Do not undergo any filler procedure with needle-free devices
  • Do not buy or use fillers sold directly to the public.
  • Do not inject yourself or others with lip and facial fillers.
  • If you experience any problems or are concerned after injection of lip or facial fillers using a needle-free device, seek care from a licensed healthcare provider.
  • Report any problems experienced after using needle-free devices for injection of fillers to MedWatch, the FDA Safety Information and Adverse Event Reporting program.
  • If you are considering a filler procedure, talk to a licensed health care provider about the procedure using an FDA-approved dermal filler. Dermal filler procedures should only be performed by licensed health care providers. 

Risks associated with the use of needle-free devices for fillers

According to the statement, the FDA is aware that these devices, and lip and facial fillers for use with these devices, are sold online directly to the public. Social media has played a key role in promoting them to increase lip volume, change the shape of the nose, reduce the appearance of wrinkles, and other related procedures. 

The FDA, however, has neither evaluated the safety and effectiveness of these products nor approved the marketing of needle-free devices for injection of any dermal fillers.

It is also included in the statement that FDA-approved dermal fillers are indicated for prescription use only and for use with a syringe (with a needle or a cannula). “Needle-free injection devices for aesthetic purposes do not provide enough control over where the injected product is placed.”

Risks include: 

  • Infection with bacteria, fungus, or virus from the filler or needle-free device
  • Bleeding or bruising
  • Scarring
  • Transmission of disease between people who use the same needle-free device
  • Blockage of a blood vessel, leading to tissue death, blindness, or stroke
  • Damage to eyes from the pressure of the needle-free device
  • Formation of lumps in the skin
  • Discoloration of the skin
  • Allergic reactions

Warning from other cosmetic injectable providers

The makers of Profhilo (a bioremodeling injectable that can address skin laxity, restore hydration, and treat other signs of aging) have also posted an announcement on their Instagram page. “Needleless Profhilo is not an approved method by IBSA DERMA.”

Injection by a needle is the only way to achieve all claims and benefits of the said product as demonstrated in the multiple published clinical journals. “The safety and efficacy of Profhilo Injectable are not applicable to other methods of administration”, the post reads. 

The only approved technique is the suggested “Bio Aesthetic Points” injection technique. Profhilo is injected only on five points of each side of the face, minimizing the risk of bruising. Read our previous post to learn more about Profhilo and how it can transform and remodel your skin

So, what exactly are Hyaluron Pens (needle-free devices)?

The Hyaluron Pen (also called hyaluronic acid pen) is a small handheld device used to self-inject dermal fillers at home. It claims to achieve the result of dermal filler, which is a cosmetic procedure performed in a medical setting, without the use of needles and at a fraction of the cost.

This needle-free pen is originally designed for people with diabetes, providing a needle-free way to deliver insulin into the subcutaneous tissues. The Hyaluron Pen works by creating pressure against the skin, forcing or pushing the filler into the skin. It relies on pressurized air and high speed, which is said to create a stream of HA that spreads under the skin. 

Upon researching online, you’ll see a number of articles, detailing their experience with the Hyaluron Pen. There are also “how-to” videos, providing tips and instructions on how to self-administer the hyaluronic acid fillers on your own. 

Don’t use the Hyaluron Pen

If you’re considering dermal fillers and other cosmetic injectables, don’t use the Hyaluron Pen. A filler treatment is an INJECTABLE procedure performed at a doctor’s office. It should only be administered by licensed, trained, and experienced physicians to avoid unwanted complications. 

While you may be able to see good results from those who have used the Hyaluron Pen themselves, this device is not safe. It has not been approved by the FDA for any cosmetic purposes. You should also know that the device has been known to cause inflammation, skin stains, and abscesses.

Other potential risks of the Hyaluron Pen include: 

  • Bacterial and fungal infections
  • Spread of transmissible diseases due to contamination (when the pen is shared with others)
  • Damage to blood vessels, eyes, and the skin (especially if too much pressure is used)

There is also a higher risk of user error with these at-home devices. Because the insertion of hyaluronic acid is delivered through extremely pressurized air, it is difficult to control the result or where the filler is inserted. It is also easy to misuse the device and insert the filler in the wrong area. This can cause severe complications that may need immediate medical attention. 

Safe and effective filler treatment

If you’re looking to plump your lips, restore volume loss using fillers, or correct the botched results of a DIY device, contact Cutis Medical Laser Clinics in Singapore today and book a consultation.

We have aesthetic doctors who are trained, licensed, and experienced to administer cosmetic injectables like fillers, Botox, and Profhilo. Also, our medical and scientific director, Dr. Sylvia Ramirez, is Harvard-trained and has years of experience with dermal fillers, including the use of Juvéderm

Read our previous post to learn the 7 things you need to know before doing lip fillers