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FDA asks dermal filler makers to indicate risk of serious injury


The U.S. Food and Drug Administration has asked manufacturers of dermal fillers to update their labeling to reflect the possible risk of serious injuries caused by unintentional injection of the fillers into the blood vessels in the face.

The agency said on Thursday it had reviewed information suggesting that the fillers could block blood vessels and restrict blood supply to tissues, potentially leading to vision impairment, blindness, stroke and damage and/or death of the skin and underlying facial structures.

The FDA said it wanted the updated labeling to include additional warnings, precautions and information about the risks associated with the filler’s usage.

While current labeling includes some information about this risk, the FDA said it believed that additional information could be included to better inform healthcare providers and patients.

Dermal fillers are facial implants injected directly into the treatment area to reduce the appearance of wrinkles and create smoother or fuller appearance of the face.

Makers of dermal fillers include Valeant Pharmaceuticals International Inc and Allergan Inc, which was bought by Actavis Plc in March.

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