The U.S. Food and Drug Administration (FDA) has issued a warning on the off-label application of Expression (Enhancement Medical), a hyaluronic-based injectable. Expression has been approved for use as an intranasal splint after trauma or surgery, but there have been reports that it’s also being used as a dermal filler.
The FDA notes that it has not studied or approved any data on Expression as a dermal filler, and hence cannot understand the severity or implications of the various adverse events that have recently surfaced, including swelling, discoloration and hard nodules. The FDA urges healthcare providers not to use Expression as a dermal filler as there is no evidence supporting its safety or efficacy.
For more information, visit http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm407900.htm.
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