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Enhancement Medical Recalls Expression Gel for Undocumented Concentration

08192014The Food and Drug Administration (FDA) has announced a recall of all units of Expression 1.5cc gel used in intranasal splint procedures. The gel, manufactured by Enhancement Medical, may have been manufactured without proper monitoring of the concentration of hyaluronic acid. Improper concentrations of active ingredients can cause adverse reactions in patients.

An initial recall of certain lots of Expression gel was issued in August 2013 after Enhancement Medical received 68 complaints of patients experiencing the following adverse effects after use.

  • swelling.
  • lumps.
  • firmness.
  • pain.
  • bruising.
  • redness.
  • itching.
  • discoloration.
  • and, development of hard nodules.

 

Enhancement Medical’s analyses of the recalled lots found that the adverse reactions were due to a hyper-concentration of hyaluronic acid. Further investigation led Enhancement Medical to recall all units since the original manufacture date of August 15, 2012 after the company was unable to confirm that the final concentration of all units of Expression gel contained the correct concentration of hyaluronic acid.

The FDA is also tracking cases where Expression gel was used as a dermal filler to fill facial wrinkles, a use for which the gel is not approved. Health care providers have been alerted to discontinue use of Expression gel for any reason and return any unused product to the manufacturer.

Medical device and drug recalls typically take place only after the FDA has received complaints of adverse reactions. It is important for patients and medical professionals to report unusual or severe side effects as soon as possible to help the FDA and manufacturers determine whether or not the product is defective or dangerous.

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