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The following quote is from Binita Ashar, MD, Director of the Office of Surgery and Infection Control Equipment at the FDA’s Center for Devices and Radiological Health:
“Today, the FDA warns the public and healthcare professionals not to use needle-free devices such as hyaluronic acid pens to inject hyaluronic acid or other lip and facial fillers, collectively referred to as dermal fillers or fillers. The FDA’s primary task is to protect patients , They may not be aware of serious adverse events related to their use, such as permanent damage to the skin, lips, and eyes.
Patients and healthcare providers should be aware that the FDA has not approved any dermal fillers for home use or over-the-counter sales for use with needle-free injection devices. These unapproved needle-free devices and fillers are usually sold directly to customers online, bypassing consultation with licensed healthcare providers, which is a key safety measure for patients to make informed decisions about their personal health.
The FDA is monitoring these unapproved needle-free devices and online platforms for dermal fillers used in needle-free injection devices. We also hope that patients and providers remain vigilant about which products have been approved by the FDA and the dangers of using unapproved products, some of which may be irreversible. The FDA will continue to remind the public and take other actions when necessary to protect public health. ”
The FDA is an agency under the U.S. Department of Health and Human Services that protects public health by ensuring the safety, effectiveness, and safety of human and veterinary drugs, vaccines and other human biological products, and medical equipment. The agency is also responsible for the safety and security of our country’s food supply, cosmetics, dietary supplements, and products that emit electronic radiation, as well as regulating tobacco products.
Post time: Nov-02-2021