FDA recommends health care providers stop using Expression by Enhancement Medical LLC as a dermal filler
August 12th, 2014 | No Comments
The U.S. Food and Drug Administration (FDA) recommends that health care providers stop using Expression by Enhancement Medical LLC as a subcutaneously administered substance, and instead refer to a list of FDA approved fillers.
This recommendation comes after the FDA became 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.
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.
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.
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.
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.
- 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
The MedWatch Safety Alert, including links to the FDA Safety Communication, is available to read online.