FDA Warns of Serious Facial Damage from Dermal Fillers

Rare yet serious side effects can transpire from unintentionally injecting soft tissue fillers into blood vessels in the face, the FDA has warned health care professionals.

Also known as dermal fillers, soft tissue fillers are injected directly into the face to reduce the appearance of wrinkles or augment lips or cheeks. When they are unintentionally injected into blood vessels, however, soft tissue fillers can restrict blood supply to tissues, which can result in embolization.

In turn, this can cause vision impairment, blindness, stroke, and necrosis, the FDA warned.

Signs and symptoms associated with injection into a blood vessel include changes in vision, signs of a stroke, blanching of the skin, or unusual pain during or shortly after the procedure.

Injection sites where blood vessel blockage has been reported more often involve the skin between the eyebrows and nose, in and around the nose, on the forehead, and around the eyes, according to the FDA’s review of medical literature and adverse event reports it received.

“With the increased popularity of soft tissue fillers, more information is available about unintentional injection into blood vessels,” the agency stated. “…The FDA continuously monitors reports of injuries caused by soft tissue fillers.”

The FDA believes additional information about this risk can be included in the labeling for soft tissue fillers to better inform health care professionals and patients.

In the meantime, it recommends health care professionals to:

• Not inject soft tissue fillers if they do not have the appropriate training or experience.
• Make sure they are familiar with the anatomy at and around the site of injection, keeping in mind blood vessel anatomy can vary among patients.
• Thoroughly inform the patient of all risks of the procedure beforehand.
• Note the approved indications for use of soft tissue fillers vary depending on the product.
• Take extra care when injecting soft tissue fillers.
• Know the signs and symptoms associated with injection into blood vessels, and have an updated plan detailing how to treat the patient if this should this occur.
• Tell patients they should seek immediate medical attention after the procedure if they experience signs and symptoms associated with injection into a blood vessel.
• Report to the FDA and manufacturer if a patient experiences an adverse event associated with unintentional injection of soft tissue filler into a blood vessel.