Pharmaceutical

FDA warns of serious side effects with wrinkle fillers

fda logo FDA warns of serious side effects with wrinkle fillersSoft tissue fillers, also known as dermal fillers, facial implants or wrinkle fillers, injected into skin on the face to smooth wrinkles can cause rare but serious side effects if unintentionally injected into blood vessels in the face, the Food and Drug Administration (FDA) warns. Unintentional injection can block blood vessels and restrict blood supply to tissues which can result in embolization, meaning that the filler material has traveled to other parts of the body. Side effects include vision impairment, blindness, stroke, damage and/or death to the skin (necrosis) and underlying facial structures.

While unintended injections into blood vessels may occur with injection to sites anywhere on the face, the FDA has reviewed literature and adverse event reports and identified certain injection locations where blood vessel blockages have been reported most often. These sites include the skin between the eyebrows and nose (glabella), in and around the nose, forehead, and around the eyes (periorbital region).

The FDA is working with manufacturers of soft tissue fillers to update their labeling to include additional warnings, precautions and other statements about the risk of unintentional injection into blood vessels.

Consumers should only have procedures using soft tissue fillers performed by health care professionals who have the appropriate training and experience. Patients who have received soft tissue fillers should be aware of signs or symptoms associated with injection into the blood vessels including changes in vision, signs of stroke, white appearance of the skin, or unusual pain during or shortly after the procedure. If these signs are experienced, seek medical attention immediately.

Any adverse events or side effects are experienced following the injection of soft tissue fillers should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.

Source: FDA