Medical Device Safety and Recalls: Adverse Events Associated with Use of Enhancement Medical's "Expression" Intranasal Splint as a Dermal Filler

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Medical Device Safety and Recalls: Adverse Events Associated with Use of Enhancement Medical's "_expression_" Intranasal Splint as a Dermal Filler

A Safety Communication has been posted titled, "Adverse Events Associated with Use of Enhancement Medical's "_expression_" Intranasal Splint as a Dermal Filler."  The FDA has become aware of adverse events associated with the use of _expression_ (also known as _expression_ Injectable) as a dermal filler, and these events have included swelling, tenderness, firmness, lumps, bumps, bruising, pain, redness, discoloration, itching, and the development of hard nodules.  The FDA has not approved this product for use as a dermal filler and recommends that health care providers stop using _expression_ by Enhancement Medical LLC as a subcutaneously administered substance.  To read the Safety Communication, please see: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm407900.htm

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