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Hyaluraonic Acid Gel Product Recall-Incorrect Concentration, Bubbling; Plus Unapproved Use


All lots of Expression 1.5cc gel, manufactured between August 15, 2012, and June 27, 2014, have been recalled because the manufacturer, Enhancement Medical, cannot ensure that Expression contains the correct concentration of hyaluronic acid. Incorrect concentration of hyaluronic acid may result in injury.

 

Expression is listed with the FDA as a Class I intranasal splint, and is intended to minimize bleeding and swelling and to prevent adhesions 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. Expression consists of hyaluronic acid that is packaged in a syringe. When used as an intranasal splint the hyaluronic acid gel functions as a protective lubricating gel, a use that presents low risk to patients.

 

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. The firm then provided customers with new product. All adverse events were associated with the subcutaneous injection of the Expression. Enhancement Medical’s investigation determined that the adverse events referenced above were a result of hyper-concentrated lots of the Expression.

 

Since Enhancement Medical cannot confirm that the final concentration of the Expression meets established specifications, the firm has expanded its recall notification to all lots of the Expression since first date of manufacture (August 15, 2012), including those lots identified in the product exchange that occurred in 2013.

 

In addition, the FDA has received reports of Expression being used as a dermal filler to fill in wrinkles on the face. Expression has not been approved by the FDA for this use. Other devices approved for this use as dermal fillers are class III devices, meaning they pose a higher risk to patient safety. The FDA has also received information raising additional concerns for Expression. For example, certain lots of Expression exhibited bubbling post-sterilization. Also, in manufacturing this product the firm uses a source bacteria and crosslinking technology that is not consistent with other FDA-approved dermal fillers.

 

Health care providers are advised to discontinue use of Expression. The company does not recommend that Expression be injected subcutaneously for any reason because the drug’s safety and effectiveness as a dermal filler has not been established in controlled clinical studies.

 

All FDA-approved injectable dermal fillers are class III (high-risk) medical devices and manufacturers are required to submit a premarket application that includes clinical data supporting safety and effectiveness, for the FDA’s review prior to marketing the dermal filler in the United States. The FDA has not received or reviewed data on the safety and effectiveness of Expression for use as a dermal filler.

 

See the FDA Safety Communication

 

See also Medical Law Perspectives, September 2012 Report: Cosmetic Surgery Gone Wrong: High Hopes Meet Unexpected Results

 

 

See also Medical Law Perspectives, April 2012 Report: Using Medical Devices Off-Label: False Claims, Overpromotion, Malpractice, and Other Dangerous Territory

 

 

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