Enhancement Medical first began production of Expression in August 2012 as an intranasal splint. Commonly used after a septorhinoplasty or a septoplasty, both of which are corrective surgeries to the nose, intranasal splints are designed to help prevent the septum and the nasal cavity from sticking together after surgery. They are also used to decrease post-operative bleeding and swelling. Expression is composed of hyaluronic acid, a naturally occurring substance that has found use in a variety of medical products, and is packaged in a syringe. When used as an intranasal splint, use of the medication presents a low risk to the patient.
More worrisome is the use of Expression as dermal or wrinkle filler by dermatologists, plastic surgeons, nurses, spas, and doctors. Expression has not been approved by the FDA for this purpose. Dermal fillers are classified as Class III medical devices and require a premarket application submitted to the FDA. For approval, the manufacturer must submit clinical trial data that supports the safety and effectiveness of the product for the intended use. To date, the FDA has received no such data. Dermal fillers are already considered to be high-risk to the consumer, and without data the FDA is unable to compare Expression to approved dermal fillers in safety.
After ordering a limited recall in 2013, Enhancement Medical expanded the recall to all product lots in August 2013 because it was unable to confirm that sold units were manufactured with the proper concentrations of hyaluronic acid. This involves over 17,800 devices, manufactured between August 2012 and June 2014.
Patients who have received Expression injections have reported a number of adverse symptoms and events, which include:
- Development of hard nodules (defined as a bump wider than 0.5 centimeters)
If you or a loved one has suffered from injuries associated with Expression, the experienced attorneys at Pope McGlamry want to ensure you are fully compensated for those injuries. For a confidential case evaluation, please call (Atlanta 877-285-7656 or Columbus 877-265-7656) or contact us online.