ROLLING PRAIRIES, Ill., October 11, 2021 / PRNewswire-PRWeb / – The American Society for Dermatologic Surgery Association (ASDSA) Congratulates the United States Food and Drug Administration (FDA) for Submitting Safety Communication Regarding Needleless Devices, such as Hyaluron Pens (HA pens) for the injection of cutaneous fillers. ASDSA had previously sounded the alarm on these devices and has resources available on these devices, including a downloadable leaflet, and has raised this issue with the FDA.
Board-certified dermatologists ASDSA members have found questionable videos on social media in which children use these devices to self-inject and promote their use to their peers. Consumers are told that these devices can create lifted and full lips, nasolabial lines, puppet lines, 11 lines and forehead lines. However, the FDA recommends against using these devices; purchase or use lip or skin fillers sold directly to the public; and injecting or injecting a filler (FDA approved dermal fillers are indicated for prescription use only).
“I am pleased that the FDA has taken note of this disturbing new trend, particularly among children using these devices on social media. We urge consumers to consult a certified dermatologist before undertaking any cosmetic procedure to ensure that all medical questions can be answered before treatment, ”said ASDSA president Matthew Avram, MD, JD. “The complexity of facial anatomy requires extensive knowledge and expertise, and patients should always undergo medical intervention by a physician who is also aware of adverse events.”
ASDSA urges its members to report adverse events to the CAPER registry, a partnership between ASDSA and Northwestern University Department of Dermatology. ASDSA members are also required to report applicable events to MedWatch, the FDA Safety Information and Adverse Event Reporting program.
Patient safety is ASDSA’s top priority, and FDA communication on the safety of these devices will help ensure consumers are aware of the risks of auto-injectable fillers. Contact [email protected] if you have any questions.
With a staff of over 6,400 physicians, ASDSA is a 501 (c) (6) association dedicated to education and advocacy on behalf of dermatological surgeons and their patients. For more information, visit http://asds.net/ASDSA
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Kristin hellquist, Association of the American Society of Dermatologic Surgery, 847-956-9144, [email protected]
SOURCE American Society for Dermatologic Surgery Association