FDA Issues Soft Tissue Filler Safety Communication

There is a safety concern with soft tissue fillers (ie: dermal fillers, injectable facial implants, or wrinkle fillers). According to the FDA, information suggests that an unintentional injection of soft tissue fillers into blood vessels in the face can result in rare, but serious side effects including blocked blood vessels and the lack of blood supply to surrounding tissues. Embolization is a possible result from this. It can, also, cause vision impairment, blindness, stroke and damage and/or death of the skin (necrosis) and underlying facial structures.

Unintentional injections into blood vessels can occur with injection sites anywhere on the face. The FDA’s review of literature and adverse event reports identifies certain injection locations where blood vessel blockage have been reported more often. These sites include the skin between the eyebrows and nose (glabella), in and around the nose, forehead, and around the eyes (periorbital region).

For the full FDA announcement and to learn more about this safety concern, visit their website here.


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