mdi Consultants
PUBLIC BEWARE
Warning from the FDA: Needle Free Devices for Certain Dermal Fillers Can Cause Permanent Harm to the Skin, Lips, or Eyes. The Safety or Efficacy of these Products Have Not Been Evaluated by the FDA!
The U.S. Food and Drug Administration (FDA) is warning the public and health care professionals not to use needle-free devices such as hyaluron pens for injection of hyaluronic acid (HA) or other lip and facial fillers, collectively and commonly referred to as dermal fillers or fillers.
The FDA is aware of serious injuries and in some cases, permanent harm to the skin, lips, or eyes with the use of needle-free devices for injection of lip and facial fillers.
The FDA has not evaluated the safety or effectiveness of needle-free devices for injection of fillers. The FDA has also not approved the marketing of needle-free devices for injection of these products. FDA-approved dermal fillers are intended for prescription use only and for use with a syringe with a needle or cannula (a small flexible tubing with a blunt tip that is inserted under the skin).
This safety communication provides:
- Important recommendations for consumers who are considering or currently using needle-free devices for injection of fillers.
- Recommendations for health care providers.
- Background and risks associated with the issue.
- Instructions for reporting problems with needle-free devices for injection of fillers to the FDA.
Unfortunately, many practitioners who use these devices are not aware of the FDA review process. They are sold the wrong bill of goods and they do not check to see if the device has FDA clearance. It is up to the consumer to question their doctors to determine if the new technologies are FDA approved for use.
mdi will continue to monitor the consumer related FDA concerns. If you have any questions on the FDA approval process and the FDA policies please contact mdi at: [email protected] and ref: Device approvals.
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