Unapproved Dermal Fillers are a prescription device that should only be injected and sold by or with a prescription from a licensed healthcare provider. The Food and Drug Administration (FDA) warns healthcare providers and patients not to use Juvederm Ultra 2, 3, or 4 because these products are not approved for use in the U. S. Needleless devices are also not approved by the FDA for injecting dermal fillers, as the safety and efficacy of such devices is unknown.
Furthermore, the FDA has not approved any dermal fillers for over-the-counter (OTC) use. The FDA has issued a Safety Communication on the Risk of Using Needleless Devices for Injecting Dermal Fillers due to serious adverse effects related to their use. 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. 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. FDA has not evaluated the safety and efficacy of needleless devices for injecting any dermal 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. FDA is monitoring reports of adverse events associated with needleless devices for injecting fillers and will update the public if significant new information becomes available. The marketing of prescription medical devices for purchase without a prescription is prohibited and may be subject to civil or criminal penalties. 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.). 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. The FDA notes that FDA-approved dermal fillers are for prescription use only and should only be administered by licensed healthcare professionals using a syringe. Because some dermal fillers naturally absorb over time, patients may need to repeat the procedure after a while to maintain the desired effect.
The safe use of dermal fillers in combination with Botox and other treatments has not been evaluated in clinical studies. Patients and healthcare providers should be aware that the FDA has not approved any dermal fillers for over-the-counter, home use, or for use with needleless injection devices. People should be tested for allergies before receiving dermal fillers made with certain materials, especially animal-derived materials, such as collagen. You should be aware that it may be difficult or impossible to remove filler material, especially permanent fillers, or fillers that are not made of materials that are normally resorbed, such as hyaluronic acid (HA). Most of the side effects associated with dermal fillers occur soon after the injection, and many go away within a few weeks. Ask your healthcare provider for the patient label to help determine if the dermal filler you are considering is right for you.
Inadvertent Injection into Blood Vessels is one of the most serious risks associated with dermal fillers. The most worrisome risk associated with their use is inadvertent injection into a blood vessel, leading to blockage of blood vessels and poor blood supply to tissues. The FDA is monitoring online platforms for these unapproved needleless devices, as well as dermal fillers intended for use with needleless injection devices. If you think you had a problem with needleless devices for injecting fillers, it is important that you report it through MedWatch Voluntary Notification Form so that appropriate action can be taken.
