Is the 30 day allergy test required for Bellafill injection according to the FDA?

Hello, Thank you for your question. Prior to a Bellafill treatment you should always consult with a physician to thoroughly discuss how Bellafill works and if this is the right procedure for you. During your consultation a small amount of the product should be intradermally administered by your physician. This will determine hypersensitivity or possible reactions. If the skin test is positive, Bellafill treatment should not be completed. If the test is negative after 48 hours (no reaction, hypersensitivity, discolouration) you can begin treatment right away.

The allergy test for Bellafill is not necessary in Canada, but it is an FDA recommendation in the United States. If a patient wants to have the treatment without the skin test, this is possible if the treating physician will do it.

outside the US very few people do skin tests (nobody requires). in the US its recommended to wait at least 30 days but we do 24-72 hours and find that there are no issues. Best, Dr. Emer.

The goal of allergy testing is to rule out allergy to bovine collagen. This is the carrier that gives substance to the initial injection. If allergy to bovine collagen, bellafill should not be used.

If newly acquired allergy to bovine collagen, 80% of bovine collagen is resorbed by 2 months. Local steroid injections and in severe cases, systemic steroids may be needed if a significant reaction. Allergy to PMMA is rare.

Bellafill® is a biostimulator injectable dermal filler that is composed of bovine collagen and polymethyl methacrylate (PMMA) and is approved by the FDA as a safe, effective treatment for nasolabial folds (“smile lines”), lasting for as long as five years.

Bellafill contains Bovine collagen. Because of the potential of allergic reaction to collagen from another species, a skin test is done weeks before treatment with the product. Patients have the right to waive the skin test if they choose. This can be done after a thorough discussion of the risks associated with this.