The U.S. Food & Drug Administration (FDA) has warned that unintentional injection of wrinkle fillers into blood vessels in the face can result in serious side effects including embolization, vision impairment, stroke and necrosis.
Wrinkle Fillers May Cause Serious Injury: FDA Warning
According to an FDA warning issued May 28, 2015, unintentional injection of wrinkle fillers can block blood vessels and restrict blood supply to tissues, resulting in embolization. This occurs when filler material travels to other parts of the body, which can cause vision damage/blindness, stroke, and death of the skin and underlying facial structures (necrosis).
While unintentional injections into blood vessels may occur anywhere on the face, they have been reported most often around the glabella (skin between the eyebrows and nose) and periorbital region (nose, forehead and eyes).
Wrinkle Filler Side Effects
- Vision impairment
- Cerebral ischemia (lack of blood flow) or cerebral
- Necrosis (death) of the skin
Various wrinkle fillers (also called dermal fillers or cosmetic fillers) have been approved by the FDA to reduce the appearance of wrinkles, and to augment the lips and cheeks. Manufacturers include Galderma and Allergan Inc, which was introduced by Actavis Plc in March 2015. FDA is working with these companies to update their products’ labeling with information about unintentional injection into blood vessels, so both healthcare providers and patients have a better understanding of the risks of wrinkle fillers.
- Before deciding whether to undergo wrinkle filler injections, consult your healthcare provider about appropriate treatment sites and the risks associated with treatment.
- Understand that the FDA has reviewed and approved different dermal fillers for use in certain areas of the face. The agency may not have reviewed the use of certain products for all locations in the body.
- Ask your healthcare provider about their training and experience with wrinkle fillers.
- Read and discuss the labeling for the specific filler you are being treated with.
- Call your doctor right away if you develop symptoms such as unusual pain, vision changes, a white appearance to the skin around the injection site, or any signs of a stroke.