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FDA Warns: Dermal Fillers May Rarely Cause Serious Injury

Unintentional injection of a dermal filler into blood vessels in the face may cause serious injury, the FDA warns; asks manufacturers to update labeling to indicate risk.

“Various soft tissue fillers, also called dermal fillers, injectable facial implants, or wrinkle fillers, are FDA-approved to reduce the appearance of wrinkles or to augment lips or cheeks. Soft tissue fillers are injected directly into a treatment area. Successful results will depend on the patient’s overall health and skin condition, the skill of the healthcare provider, the location of injection, and the type of filler used”.

The US Food and Drug Administration (FDA) is warning healthcare providers and the public about the possibility of rare, but serious, injuries that may occur as a result of unintentional injection of a soft tissue filler into blood vessels in the face.

“Soft tissue fillers should be injected only by health care providers who have appropriate training and experience and who are knowledgeable about the anatomy at and around the injection site,” the FDA says.