August 5, 2014 — The U.S. Food and Drug Administration (FDA) is warning that Expression Injectable, manufactured by Enhancement Medical, LLC, should not be used as a wrinkle filler due to the risk of severe side effects.
Expression is only approved as an intranasal splint, but it has been improperly marketed as an “injectable filler,” according to a warning letter issued by the FDA in June 2014.
Inspectors also discovered that Enhancement Medical routinely failed to report adverse events to the FDA, recorded them improperly, waited months to investigate complaints, and closed complaints without following up on the patient’s outcome.
These adverse events included patients who experienced hard nodules that failed to respond to treatment, extreme swelling, itching, lumps, fever, and more. In one incident:
“The FDA has received a report of a patient developing firm masses in the face after being injected with the Expression product, which was used as a dermal filler. An attempt was made to dissolve the masses, but the report notes that the patient was left with an “obvious deformity.”
Expression Injectable is similar to FDA-approved wrinkle fillers, but it is not approved for this purpose. FDA-approved dermal fillers are Class III (high-risk) medical devices that must undergo rigorous safety testing before they are allowed on the market. Expression Injectable has never been evaluated in clinical trials as a dermal filler, and therefore the FDA does not know if it is safe or effective.
Expression Injectable Side Effects
- Hard nodules
- Obvious deformity