FDA Safety Communication: Unintentional Injection of Soft Tissue Filler into Blood Vessels in the Face

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Title: FDA Safety Communication: Unintentional Injection of Soft Tissue Filler into Blood Vessels in the Face
Office of Women's Health, FDA

May 2015
www.fda.gov/womens

Unintentional Injection of Soft Tissue Filler into Blood Vessels in the Face

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.

The FDA is alerting health care providers and consumers about the possibility of rare, but serious, injuries that may occur due to unintentional injection of soft tissue filler into blood vessels in the face.

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.

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