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Injury Associated with Off Label Use of Intranasal Splint as Dermal Filler


Expression, manufactured by Enhancement Medical LLC, is listed with the FDA as an intranasal splint, and is intended to minimize bleeding and swelling and to prevent adhesions (sticking together) 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. FDA has received reports of Expression being used as dermal filler to fill in wrinkles on the face. The FDA has not approved this product for use as dermal filler and recommends that health care providers stop using Expression by Enhancement Medical LLC as a subcutaneously administered substance. Other devices approved for use as dermal filler are class III devices, meaning they pose a higher risk to patient safety.

 

The FDA has become aware of adverse events associated with the unapproved use of the Expression product as dermal filler. These events have included swelling, tenderness, firmness, lumps, bumps, bruising, pain, redness, discoloration, itching, and the development of hard nodules.

 

The FDA 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 noted that the patient was left with an “obvious deformity.”

 

Although Expression contains components similar to FDA-approved dermal fillers, 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. While the adverse events reported appear similar to those that may arise from injection with FDA-approved dermal fillers, without reviewing clinical data supporting the safety and effectiveness, the FDA cannot fully understand the nature, severity, or rate of occurrence of adverse events associated with Expression and has no assurance of this product’s safety or effectiveness when used as a dermal filler.

 

For the reasons noted above the FDA recommends health care providers stop using Expression as dermal filler. The FDA issued a warning letter to Enhancement Medical LLC on June 4, 2014, advising the company of multiple quality system, correction/removal, and medical device reporting violations that were revealed during an inspection.

 

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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