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

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

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.

Source: Healio

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Comment: Hyaluronic acid has multiple uses in medicine but the HA products used as volumizing fillers have to be certified and approved for this indication. Generally, they have to have a higher degree of purity, sterility and specific molecular configurations to be used in this way.