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Independent Panel Comments on Facial Fillers’ Safety

-November 26, 2008

On Nov. 18, an independent advisory panel convened by the FDA released its conclusions regarding the safety of the dermal facial fillers used widely in the U.S., including:

• Juvederm
• Restylane
• Artefill
• Perlane

Recommending Sterner Warnings
 The panel's main recommendations are:

(1) The warning labeling of these products should be strengthened to reflect the serious side effects that have been reported to the FDA, and

(2) The labeling should note that some side effects can occur months or even years after a dermal filler treatment.

Hundreds of Adverse Effect Reports
In a six-month period ending in September 2008, the FDA received 930 reports of adverse effects in patients who had been injected with a facial filler — most of the treatments were within the past 10 years, since these products are relatively new.

The side effects were often quite serious, and included:

• allergic reactions
• blisters
• bruising, bleeding
• bumps or lumps under the skin
• cysts
• infection
• inflammatory reactions that resulted in cold sores, arthritis flare-ups, nodule formation, or other problems
• migration of the filler material (moving to another site on the face)
• numbness
• cars
• swelling

Hospital, Emergency Room Treatment
Although no filler-related deaths were reported, 19 of the patients had to be treated in an emergency room (for life-threatening allergic reactions), 12 had to be admitted to a hospital for treatment of an infection, 94 patients needed surgical intervention, and 638 of the patients needed medical treatment as an effort to resolve the problem(s) created by the facial filler.

Among the other concerns the panel noted are:

• the off-label uses of dermal fillers, including their use for plumping the lips
• the limited data on how dark-skinned individuals react to dermal fillers
• administration of facial fillers by non-physician, untrained personnel, or in non-medical settings

(Source: MSNBC)

If you have suffered injuries following a facial filler procedure, contact us today to speak with an experienced legal professional who will help you recover compensation for your losses.