WASHINGTON, D.C. – We all want a smooth, supple face, but the FDA is warning that only professionals should be making risky facial injections of soft tissue fillers.
Today, the Food and Drug Administration (FDA) posted a Safety Communication about the unintentional injection of soft tissue fillers into blood vessels in the face. Rare, but serious, injuries may be caused if soft tissue fillers are unintentionally injected into blood vessels. The FDA warned that only health care providers who have appropriate training and experience and who are knowledgeable about the anatomy of the face should inject these products.
The FDA said that “soft tissue fillers”, also called dermal fillers, injectable facial implants, or wrinkle fillers, can create a smoother or fuller appearance of the face. They are FDA-approved to reduce the appearance of wrinkles or to augment lips or cheeks.
However, the FDA has reviewed information that suggests unintentional injection of soft tissue fillers into blood vessels in the face can result in rare, but serious side effects. Unintentional injection can block blood vessels and restrict blood supply to tissues. Sometimes this can result in embolization. This means the filler material has traveled to other parts of the body. This can cause vision impairment, blindness, stroke and damage and/or death of the skin (necrosis) and underlying facial structures.
The FDA recommends that only dermatologists, plastic surgeons, cosmetic surgeons, dentists, and other medical providers who treat patients using soft tissue fillers should deb consulted prior to this procedure.
