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

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.