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FDA Warns Against Using Needle-Free Injection Devices For Dermal Fillers
1Diane S. Aschenbrenner is a former member of the faculty at Notre Dame of Maryland University and the Johns Hopkins University School of Nursing. She coordinates Drug Watch : diane.aschenbrenner@gmail.com .
The American Journal of Nursing
|January 27, 2022
Summary
The Food and Drug Administration (FDA) warns against unapproved needle-free injection devices for dermal fillers. These devices pose risks and are not FDA-approved for cosmetic use.
Area of Science:
- Cosmetic Dermatology
- Medical Device Safety
Background:
- Needle-free injection devices are being marketed for dermal filler administration.
- These devices bypass traditional administration methods using needles or cannulas.
- The safety and efficacy of these needle-free devices for dermal fillers are not established.
Purpose of the Study:
- To communicate a critical safety warning regarding needle-free injection devices for dermal fillers.
- To inform healthcare professionals and the public about the unapproved status of these devices.
- To provide guidance on the proper use of FDA-approved dermal fillers.
Main Methods:
- Review of FDA safety communications and regulatory guidelines.
- Analysis of the approved methods for dermal filler administration.
- Dissemination of warnings through official channels.
Main Results:
- Needle-free devices for dermal filler injection are not FDA-approved.
- FDA-approved dermal fillers require prescription and administration via syringe with a needle or cannula.
- Potential for adverse events associated with unapproved devices.
Conclusions:
- Healthcare professionals must not use or recommend unapproved needle-free injection devices for dermal fillers.
- Patients should be advised against purchasing these devices, especially online.
- Adverse events should be reported to the FDA MedWatch system for monitoring and action.