Expressions Nasal Splint Linked to Off-Label Use Complications: FDA
Federal health regulators are warning healthcare professionals that they should discontinue use of Expression Intranasal Splint’s as an alternative dermal filler injection, due to the risk that the injections may cause serious problems for patients.
An FDA safety communication was released on August 5, following complaints that indicated Expressions Nasal Splint injections may leave patients with obvious deformities.
The agency warned that there are also unknown risks associated with using Expressions hyaluronic acid injection as a dermal filler, and that the drug has not been medically approved for that use.
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Expression intranasal splint is a product that is intended to minimize bleeding and swelling, as well as preventing adhesions between the septum and the nasal cavity. The splints are placed in the nasal cavity after surgery or trauma and usually constructed from plastic, silicone, or absorbent material. The hyaluronic acid gel is then injected around the splint to act as a protective lubricating gel.
The use of Expressions hyaluronic acid injections has only been approved by the FDA to act as a protective lubricating gel around the stents. Although doctors may use alternative treatments as they see best fitting for the patient, this product has not been cleared by the FDA as a safe and effective dermal filler treatment.
Recently, the FDA has received reports of licensed dermal filler healthcare professionals and doctors performing augmentation and reconstruction related medical procedures using Expression hyaluronic acid injections as dermal fillers to fill in wrinkles on patients faces.
The agency indicate that adverse event reports have been received involving patients suffering from swelling, tenderness, firmness, lumps, bumps, bruising, pain, redness, discoloration, itching, and the developing of hard nodules following those procedures. In one of the events, a patient developed masses in the face after being injected with the Expressions product, in attempt to fill in wrinkles. The doctors attempted to dissolve the masses but the report states the patient was left with obvious deformities in the face.
The FDA advises doctors to discontinue using Expressions as a dermal filler and stick to a list of FDA-approved fillers.
In June, the FDA issued a warning letter to Enhancement Medical LLC, citing multiple quality control problems. The letter was the result of an FDA inspection from December 16, 2013 to January 15, 2014 at the company’s Wauwatosa, Wisconsin facility, where the Expressions intranasal splints are manufactured.
Included in the letter is a warning that some documents refer to the Expressions Intranasal Splint as an “injectable filler.” The FDA warned the company that using that language could constitute an off-label promotion of Expression for an unapproved use. While doctors are able to use drugs and medical devices how they see fit, manufacturers are only allowed to promote them for uses approved by the FDA.
The inspectors also found that the company had failed to establish a number of quality control procedures to verify that the splints were of consistent formulation, failed to investigate causes of non-conformities, and failed to identify and fix problems that led to non-conformities. The FDA investigators said the company was also not adequately investigating complaints about its product, and not properly reporting those complaints to the FDA.< "Your firm routinely closes complaint records without an evaluation of whether the complaint represents an event which is required to be reported to FDA as a medical device report (MDR)," inspectors determined. "Your firm failed to complete separate complaint records for complaints involving multiple lots or multiple patients. As a result, your complaint data is inaccurate and incomplete for analyzing trends."The FDA provided a laundry list of examples of complaints that appear to have been ignored or mishandled.
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