FDA MedWatch - Unintentional Injection of Soft Tissue Filler into Blood Vessels in the Face: FDA Safety Communication - Risk of Serious Patient Injury

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Title: FDA MedWatch - Unintentional Injection of Soft Tissue Filler into Blood Vessels in the Face: FDA Safety Communication - Risk of Serious Patient Injury
MedWatch logoMedWatch - The FDA Safety Information and Adverse Event Reporting Program

Unintentional Injection of Soft Tissue Filler into Blood Vessels in the Face: FDA Safety Communication - Risk of Serious Patient Injury

AUDIENCE: Dermotology, Surgery, Neurology, Patient

ISSUE: 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.

While unintentional injections into blood vessels may occur with injection sites anywhere on the face, the FDA’s review of literature and adverse event reports submitted to the FDA 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).

FDA is working with manufacturers to update their labeling. The requests asks that the labeling include additional warnings, precautions, and other statements about the risk of unintentional injection into blood vessels, consistent with the recommendations in this communication, so that both health care providers and patients would have a better understanding of the risks.

BACKGROUND: 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.

RECOMMENDATIONS:

For a complete list of recommendations for healthcare professionals and patients, see the FDA Safety Communication

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Read the MedWatch safety alert, including a link to the FDA Safety Communication, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm448439.htm


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