Enhancement Medical got the FDA’s highest-risk recall warning over manufacturing concerns about the company’s Expression Intranasal Splint.
Originally affecting a limited lot of the Expression product, the recall now includes every unit of the gel since Enhancement began manufacturing in 2012. The company said it launched the recall because it can’t guarantee that the products were manufactured appropriately, especially after receiving reports consistent with too much hyaluronic acid in the product.
"In August 2013, Enhancement Medical asked customers to return certain lots of the Expression after receiving multiple complaints documenting adverse events such as swelling, tenderness, firmness, lumps, bumps, bruising, pain, redness, discoloration, itching, and the development of hard nodules," according to the FDA recall report. "Enhancement Medical’s investigation determined that the adverse events referenced above were a result of hyper-concentrated lots of the Expression."
Hyaluronic acid is a naturally occurring biological substance commonly found in human eyes and joints. The product is used as a filler in certain cosmetic procedures as well as in wound healing and in some eye surgeries.
Enhancement’s Expression product uses the substance to form an intranasal splint to minimize bleeding and swelling after surgery or trauma. The injectable solution is considered a high-risk product be classification as a dermal filler, the FDA noted.
The federal watchdog agency further noted that some physicians had been using Expression in an off-label manner to fill in wrinkles in the face. The agency warned that Expression has not been approved for that type of use and that misuse could pose a risk to patients.
The FDA further noted "additional concerns," including reports that certain lots of Expression were seen "bubbling" after sterilization. The agency also warned that Enhanced has been manufacturing its products using methods that are not consistent with other FDA-approved dermal fillers.