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.
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.