US FDA Panel Grapples With Dermal Filler Adverse Events
Physicians on the panel backed suggestions including improved labeling, broadening the patient pool for clinical trials, and more thoroughly tracking adverse events.
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Agency safety communication says needle-free dermal filler “pens” sold OTC on social media could pose a serious risk to consumers. It's aware of serious injuries, including permanent harm to skin, lips, or eyes with the use of needle-free devices for injection of lip and facial fillers.
The agency’s warning says that needle-free dermal filler “pens” sold on social media could pose a serious risk to consumers.
The US agency will hold a meeting of its plastic surgery devices panel to discuss risks associated with, and patient preference for, dermal fillers.