It sounded too good to be true.
Turns out, it was.
The hyaluronic acid pen – also called the hyaluron pen – was marketed as an inexpensive, needleless and painless alternative to lip fillers. A small, hand-held device originally intended to painlessly treat diabetic patients with insulin throughout the day, it uses force from pressurized air to create microscopic holes, through which hyaluronic acid filler is pushed into the skin for fuller lips.
And while hyaluron pens are often treatments performed by aestheticians, the way the pens use uncontrollable pressure to force the injectable into the lips with no precision should be of great concern.
This not only leads to poor aesthetic outcomes, resulting in lumps and unevenness but also much higher risk for vascular occlusion – or cutting off blood supply to tissue, potentially leading to skin loss, blindness, or stroke.
To the contrary, lip fillers with a needle and an experienced provider with an in-depth knowledge of anatomy can provide optimal aesthetic outcomes.
For more visual context, check out this video from Uy Dam, a board-certified Nurse Practitioner.
What The FDA Says ABout Hyaluron Pens
The U.S. Food and Drug Administration, as well as medical and cosmetic experts, now warn that the device can not only potentially botch your lips but is also dangerous with risks including …
- 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 (necrosis), 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 reaction
The FDA statement reads:
“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.”
It goes on to further specify consumer and medical recommendations.
For consumers, it recommends:
- Do not undergo any filler procedure with needle-free devices.
- Do not buy or use lip or facial fillers sold directly to the public.
- Do not inject yourself or others with lip and facial fillers using any device. FDA-approved dermal fillers are indicated for prescription use only.
- 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 health care 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. For more information, see the FDA’s webpage: Dermal Fillers (Soft Tissue Fillers).
For medical professionals, it recommends:
- 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.
The Bespoke Rx Difference
Sometimes, a quick-fix, DIY solution or a too-good-to-be-true product isn’t worth the hype. And it certainly isn’t worth the risks.
Our goal at Bespoke Rx is to enhance your natural beauty with safe products and tested techniques.
The different types of dermal fillers offered today all provide unique benefits. At Bespoke Rx, we most often use fillers made by Restylane as well as Revanesse Versa. We may use a combination of different fillers depending on what we need to achieve.
Whatever your goal, we can help you discover your true potential by transforming your appearance through aesthetic medicine tailored to your unique needs.
Schedule a consultation with us or call us at (813) 203-6196 for a customized treatment plan today!