August 06, 2014
1 min read

Unapproved use of intranasal splint as dermal filler linked to adverse events

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The U.S. Food and Drug Administration announced that some health care providers have used an intranasal splint from Enhancement Medical as a dermal filler — an indication for which the product has not been FDA-approved.

Use of the intranasal splint, Expression, as a dermal filler has resulted in reports of adverse events, including swelling, tenderness, lumps, bumps, bruising, pain, redness, discoloration, itching and the development of hard nodules, according to a press release from the FDA.

As such, the FDA recommended that health care providers stop using Expression as a subcutaneously administered device.

Expression is FDA-approved to help minimize bleeding and swelling after surgery or trauma to prevent adhesions between the septum and nasal cavity. The splint is made of hyaluronic acid gel packaged in a syringe that, when used as intended, functions as a protective lubricant with low risks to patients.

The FDA has received reports of Expression being used as a dermal filler to reduce wrinkles on the face. Dermal fillers are classified by the FDA as class III devices, meaning they pose a higher risk to patient safety, according to the release.

The FDA has not received or reviewed data on the safety and effectiveness of Expression for use as a dermal filler.

To read the full FDA press release, click here.