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The Food and Drug Administration has issued a warning about adverse events associated with use of the Expression intranasal splint as a dermal filler – an unapproved indication for this product.
The FDA released its statement on Aug. 5.
Expression, also known as "Expression Injectable," manufactured by Enhancement Medical LLC, is a hyaluronic acid product packaged in a syringe, and it is cleared by the FDA for use only as an intranasal splint.
But off-label use of the product as a dermal filler has been associated with reports of swelling, tenderness, firmness, bruising, pain, redness, discoloration, itching, and the development of hard nodules, according to the FDA statement. The reports include one case of a patient who developed firm masses in the face after the Expression product was injected as a dermal filler. "An attempt was made to dissolve the masses, but the report notes that the patient was left with an ‘obvious deformity,’ " the FDA statement said.
The agency noted that the components of Expression are similar to those of dermal fillers approved by the FDA, and the adverse event reports "appear similar" to those reported with those approved products. However, dermal fillers are classified by the agency as class III, high-risk medical devices and "without reviewing clinical data supporting the safety and effectiveness the FDA cannot not 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," the statement said.
A list of FDA-approved dermal fillers is available here.
Health care professionals and consumers should report adverse events associated with this product by visiting the FDA’s MedWatch site, or by calling 800-332-1088.
The Food and Drug Administration has issued a warning about adverse events associated with use of the Expression intranasal splint as a dermal filler – an unapproved indication for this product.
The FDA released its statement on Aug. 5.
Expression, also known as "Expression Injectable," manufactured by Enhancement Medical LLC, is a hyaluronic acid product packaged in a syringe, and it is cleared by the FDA for use only as an intranasal splint.
But off-label use of the product as a dermal filler has been associated with reports of swelling, tenderness, firmness, bruising, pain, redness, discoloration, itching, and the development of hard nodules, according to the FDA statement. The reports include one case of a patient who developed firm masses in the face after the Expression product was injected as a dermal filler. "An attempt was made to dissolve the masses, but the report notes that the patient was left with an ‘obvious deformity,’ " the FDA statement said.
The agency noted that the components of Expression are similar to those of dermal fillers approved by the FDA, and the adverse event reports "appear similar" to those reported with those approved products. However, dermal fillers are classified by the agency as class III, high-risk medical devices and "without reviewing clinical data supporting the safety and effectiveness the FDA cannot not 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," the statement said.
A list of FDA-approved dermal fillers is available here.
Health care professionals and consumers should report adverse events associated with this product by visiting the FDA’s MedWatch site, or by calling 800-332-1088.
The Food and Drug Administration has issued a warning about adverse events associated with use of the Expression intranasal splint as a dermal filler – an unapproved indication for this product.
The FDA released its statement on Aug. 5.
Expression, also known as "Expression Injectable," manufactured by Enhancement Medical LLC, is a hyaluronic acid product packaged in a syringe, and it is cleared by the FDA for use only as an intranasal splint.
But off-label use of the product as a dermal filler has been associated with reports of swelling, tenderness, firmness, bruising, pain, redness, discoloration, itching, and the development of hard nodules, according to the FDA statement. The reports include one case of a patient who developed firm masses in the face after the Expression product was injected as a dermal filler. "An attempt was made to dissolve the masses, but the report notes that the patient was left with an ‘obvious deformity,’ " the FDA statement said.
The agency noted that the components of Expression are similar to those of dermal fillers approved by the FDA, and the adverse event reports "appear similar" to those reported with those approved products. However, dermal fillers are classified by the agency as class III, high-risk medical devices and "without reviewing clinical data supporting the safety and effectiveness the FDA cannot not 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," the statement said.
A list of FDA-approved dermal fillers is available here.
Health care professionals and consumers should report adverse events associated with this product by visiting the FDA’s MedWatch site, or by calling 800-332-1088.
