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Enhancement Medical’s Expression Gel Recalled

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Jasjit Mundh3 years ago

Enhancement Medical has recalled its “Expression” intranasal gel, which is used to form an intranasal splint, due to faulty manufacturing concerns.

About the Intranasal Gel Recall

According to MassDevice, the Food and Drug Administration (FDA) has issued the highest-risk label recall for the Enhancement Medical gel because the gel has too much hyaluronic acid.

This can lead to swelling, tenderness, firmness, lumps, bumps, bruising, pain, redness, discoloration, itching, and the development of hard nodules. 70 complaints about the product have been reported.

The gel is used as an intranasal splint after surgery or trauma to reduce swelling and bleeding. Customers are recommended to stop using the gel immediately.

The FDA also states that some physicians have been using the gel to fill wrinkles in the face. Expression intranasal gel is not manufactured for such use (as a dermal filler). Misuse of the gel poses a extreme risk to patients.

Description of Recalled Intranasal Gel

  • The recall includes every unit of the gel since Enhancement began manufacturing in 2012.
  • The reported medical problems are caused by hyper-concentrated lots of the Expression gel.
  • Certain lots of the Expression gel were seen “bubbling” after sterilization.

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