August 5, 2014 — Expression Injectable, manufactured by Enhancement Medical, LLC, is an intranasal splint that should not be used as a wrinkle filler because it can cause severely disfiguring side effects that may be permanent, according to a Safety Communication from the FDA.
Expression Injectable is a gel that is used as an intranasal splint after surgery or trauma to the nose. Intranasal splints are not supposed to be injected through the skin or placed into tissues on the face.
Unfortunately, the FDA has received numerous complaints from patients who experienced hard nodules on the face after they were treated with Expression Injectable. In some cases, the nodules failed to respond to treatment:
“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.”
In June, FDA inspectors issued a warning letter after finding that Expression Injectable was improperly marketed as an “injectable filler.” They also found that Enhancement Medical failed to report adverse events, improperly recorded the number of people who were injured, waited nearly a year to follow-up on injury reports, and closed reports without following up on patients.
No Safety Studies of Expression Injectable as Wrinkle Filler
Although Expression Injectable contains ingredients that are similar to FDA-approved wrinkle-fillers, it is not approved for this purpose. The FDA classifies wrinkle fillers as Class III (“high risk”), which means they must go through a rigorous premarket approval process that includes clinical trials to evaluate safety and effectiveness. It is unknown if Expression Injectable is safe or effective when it is used as a wrinkle filler.
Side Effects of Expression Injectable
The FDA has received reports of the following adverse events when Expression Injectable is used as a wrinkle filler, and in some cases side effects do not improve with treatment:
- Hard nodules
- Obvious deformity