Expression Injectable by Enhancement Medical: FDA Safety Communication - Adverse Events Associated with Unapproved Use As a Dermal Filler
UPDATED 8/14/2014. Recall classified as Class I.
AUDIENCE: Dermatology, Surgery, Dentistry, Nursing
ISSUE: The FDA has become aware of adverse events associated with the unapproved use of the Expression product, hyaluronic acid that is packaged in a syringe, as a dermal filler. Events have included swelling, tenderness, firmness, lumps, bumps, bruising, pain, redness, discoloration, itching, and the development of hard nodules.
BACKGROUND: Expression is listed with the FDA as an intranasal splint, and is intended to minimize bleeding and swelling and to prevent adhesions (sticking together) between the septum and the nasal cavity. Intranasal splints are placed in the nasal cavity after surgery or trauma and are usually constructed from plastic, silicone, or absorbent material.
The FDA issued a warning letter to Enhancement Medical LLC on June 4, 2014, advising the company of multiple quality system, correction/removal, and medical device reporting violations that were revealed during an inspection.
RECOMMENDATION: FDA recommends that health care providers stop using Expression by Enhancement Medical LLC as a subcutaneously administered substance and instead use the list of FDA approved fillers. In addition, patients who have received treatment with Expression as a dermal filler should be monitored for adverse events and referred for corrective treatment when appropriate. For further detailed instructions for people undergoing procedures that use dermal fillers or their health care providers please see the FDA Safety Communication.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[08/14/2014 - Recall Notice - FDA]