FDA Warns Against Off-Label Use of Hyaluronic Acid Product

Megan Brooks

Disclosures

August 06, 2014

The hyaluronic acid product Expression injectable (Enhancement Medical LLC) should not be used off-label as a dermal filler, the US Food and Drug Administration (FDA) warned in a safety alert issued yesterday.

Expression injectable is FDA-approved as an intranasal splint after surgery or trauma to minimize bleeding and swelling and to prevent adhesions between the septum and the nasal cavity. It is not approved as dermal filler.

The FDA says it has learned of adverse events associated with the unapproved use of the injectable as a wrinkle filler, including swelling, tenderness, firmness, lumps, bumps, bruising, pain, redness, discoloration, itching, and the development of hard nodules.

In one instance, a patient developed firm masses in the face after being injected with the product. An attempt to dissolve the masses failed and the patient was left with "obvious deformity," the FDA reports.

The FDA recommends that healthcare providers not use Expression by Enhancement Medical LLC as a dermal filler and instead use an FDA-approved dermal filler.

Patients who have received Expression as a dermal filler "should be monitored for adverse events and referred for corrective treatment when appropriate," the FDA says.

On June 4, the FDA issued a warning letter to Enhancement Medical LLC advising the company of "multiple quality system, correction/removal, and medical device reporting violations that were revealed during an inspection."

Among the specific violations uncovered, Expression injectable was improperly marked as an "injectable filler."

Although Expression injectable contains ingredients that are similar to FDA-approved wrinkle fillers, it is not approved for this purpose, and the FDA has not received or reviewed data on the safety and effectiveness of Expression for use as a dermal filler, the FDA notes.

More information on the FDA warning is available on the agency's Web site.

To report problems with this product or other products, MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at http://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.

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