The Food and Drug Administration (FDA) has not approved any type of hyaluronic acid or other lip and facial fillers for over-the-counter, home use, or for use with needleless injector devices. Needleless devices are not approved by the FDA for injecting dermal fillers, and their safety and efficacy is unknown. The FDA has also not approved any dermal fillers for over-the-counter (OTC) use. The FDA is aware of serious adverse effects related to the use of needleless devices for injecting dermal fillers and has issued a Safety Communication on the Risk of Using Needleless Devices for Injecting Dermal Fillers.
Needleless injectors are portable devices or “pens” that use high pressure to force substances, such as fillers, into the body. Substances loaded in pens are normally sold separately. The FDA is aware that needleless devices and lip and facial fillers for use with these devices are sold online directly to the public, and their use is promoted on social media to increase lip volume, improve the appearance of wrinkles, change the shape of the nose, and other similar procedures. The FDA advises the public and healthcare professionals not to use needleless devices, such as hyaluron pens for hyaluronic acid (HA) injection or other facial and lip fillers, collectively and commonly referred to as dermal fillers.
FDA is aware of serious injury and, in some cases, permanent damage to the skin, lips, or eyes with the use of needleless devices for injecting facial and lip fillers. The FDA has also not approved the marketing of needleless devices for the injection of these products. FDA-approved dermal fillers are designed for prescription use only and for use with a syringe with a needle or cannula (a small flexible tube with a blunt tip that inserts under the skin). Needleless injection devices for aesthetic purposes do not provide sufficient control over where the injected product is placed.
Facial and lip filler products sold directly to consumers online may be contaminated with chemicals or infectious organisms. Complications may require immediate medical attention from a licensed healthcare provider. Some complications may not be reversible. The FDA continues to evaluate the commercialization of needleless devices for injecting fillers and will take appropriate action. If you think you had a problem with needleless devices for injecting fillers, FDA encourages you to report the problem through the MedWatch Voluntary Notification Form.
Health care personnel employed by facilities that are subject to FDA user center reporting requirements must follow the reporting procedures established by their centers. There are 19* BRANDS of FDA-approved facial dermal fillers available to providers for cosmetic injections. Each one has multiple and specific indications (lips, cheeks, etc.). The count of 19 does not include dual versions of the same product, with and without lidocaine, (ie. Produced by Swiss hyaluronic acid product manufacturing company Teoxane, RHA Redensity is a gel implant or dermal filler that is injected into specific areas of facial tissue to reduce the appearance of lines and wrinkles. Inadvertent Injection into Blood Vessels The most serious risk associated with dermal fillers is accidental injection into a blood vessel.
The safe use of dermal fillers in combination with Botox and other treatments has not been evaluated in clinical studies. Because some dermal fillers naturally absorb over time, patients may need to repeat the procedure after a while to maintain the desired effect. Injecting dermal fillers into the face and hands can improve the appearance of facial lines and volume loss caused by age or certain medical conditions. Some dermal fillers also contain lidocaine, which is intended to reduce injection-related pain or discomfort. Dermal fillers may not be suitable for people with certain conditions, such as bleeding disorders or some allergies.
Most of the side effects associated with dermal fillers occur soon after the injection, and many go away within a few weeks.
