FDA: Stop using unapproved dermal filler

August 6, 2014

Doctors and other healthcare providers should stop subcutaneous injection use of Expression by Enhancement Medical LLC, the Food and Drug Administration has announced. The product is not approved as a dermal filler.

Doctors and other healthcare providers should stop subcutaneous injection use of Expression by Enhancement Medical LLC, the Food and Drug Administration (FDA) announced this week. It is not approved as a dermal filler.

 

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Expression, consisting of hyaluronic acid that is packaged in a syringe, is approved as an intranasal splint to minimize bleeding and swelling and to prevent the adhesions in the septum and nasal cavity, a press release stated. This is considered a Class I device, and used this way, it presents low risk to patients, the FDA said.

Adverse events associated with the product's use as a treatment for wrinkles have included swelling, tenderness, firmness, lumps, bumps, bruising, pain, redness, discoloration, itching, and the development of hard nodules, the FDA stated. Devices approved for this use are considered Class III devices, which pose a higher risk to patient safety.

In a letter dated June 4, 2014, the FDA advised Enhancement Medical LLC of multiple inspection violations, including misleading statements about the device's use as a dermal filler, and requested immediate resolution.

The FDA recommends that healthcare providers use only FDA approved fillers, monitor patients who have received treatment with Expression for adverse events, and report any side effects related to the unapproved use of this product to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

 

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