FDA Warns Against Using 'Expression' Injectable as Wrinkle-FillerAug 13, 2014
The hyaluronic acid product Expression injectable should not be used off-label as dermal filler, the U.S. Food and Drug Administration (FDA) warns. In a Safety Alert issued August 5, 2014, the agency said that this type of unapproved use is associated with swelling, tenderness, firmness, lumps, bumps, bruising, pain, redness, discoloration, itching, and the development of hard nodules.
Enhancement Medical LLC, the manufacturer of Expression, received a warning letter from the FDA dated June 4, 2014 “advising the company of multiple quality system, correction/removal, and medical device reporting violations that were revealed during an inspection” the FDA said. The letter also accuses Enhancement Medical of improperly marketing Expression as an “injectable filler”.
The FDA has approved Expression for use as an intranasal splint. After surgery and trauma, this product is meant to reduce bleeding and swelling and prevent the septum from sticking to the nasal cavity. Although it has some similar ingredients to other FDA-approved wrinkle fillers, the agency has not approved it for this purpose.
The agency notes that approved injectable fillers have undergone clinical testing because they are classified as class III, or high risk. The FDA has reviewed data showing that the products are safe and effective for use. No such safety review has been conducted for the use of Expression as dermal filler. The FDA wrote on its website that “without reviewing clinical data supporting the safety and effectiveness the FDA cannot not fully understand the nature, severity, or rate of occurrence of adverse events associated with Expression and has no assurance of this product’s safety or effectiveness when used as a “dermal filler.”
The FDA reported that one patient was left with “obvious deformity” after off-label use of Expression. After the product was injected, firm masses developed and the attempts to remove them were unsuccessful. Patients who have received expression as dermal filler “should be monitored for adverse events and referred for corrective treatment when appropriate,” the agency recommends.