Last week, a US Food and Drug Administration (FDA) panel encouraged changes to product labels on popular cosmetic wrinkle treatments, such as Restylane® and Juvederm®, to warn consumers about scarring and other complications that can occur weeks or years after injection.

The panel said current product labels on wrinkle fillers only discuss immediate and temporary side effects, such as redness and swelling. However, over the past 5 years, the FDA has received over 800 reports of injuries associated with wrinkle fillers. These injuries included infection, bleeding, lumps, and even facial disfigurement. Nearly 100 patients who underwent the cosmetic procedure required a surgical procedure related to complications of the injection.

According to the FDA, an estimated 1.5 million wrinkle filler procedures were performed last year in order to reduce the appearance of facial lines. Many of these procedures were outside of FDA-approved indications, including lip injection, and an increasing number of procedures are conducted in non-medical facilities, such as medical spas. The FDA is considering whether to update the warning labels or require manufacturers to conduct more extensive studies to support product approval applications.