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FDA Panel to Evaluate Side Effects of Restylane, Juvederm and Other Dermal Fillers

A panel of outside advisers to the FDA will meet this week to review reports of dermal filler side effects, and to consider whether the regulatory agency should place new warnings or instructions on the injections used to reduce wrinkles and scarring.

According to an FDA document posted Friday on the agency’s website, there have been 930 reports of dermal filler side effects received between 2003 and September 20, 2008. Some of the problems were associated with administration of the injections by untrained professionals or in a setting other than a doctor’s office.

Although no specific products were identified by the FDA, the more popular dermal fillers available include Restylane and Perlane from Medicis, Juvederm from Allergan Inc. and Radiesse from Bioform Medical.

Dermal fillers, which are also known as wrinkle fillers, are injections given to smooth wrinkles for a younger look or to reduce the appearance of scarring. According to the American Society for Aesthetic Plastic Surgery, about 84,000 men and 1.36 million women received a wrinkle filler injection in 2007.

The FDA advisory panel is scheduled to meet tomorrow in Washington, D.C. to review the safety of these products and whether any regulatory actions, such as strengthened warnings or additional instructions, may be necessary to protect the public.

The FDA review indicates that some people given dermal fillers suffered “serious and unexpected” side effects, such as facial palsy, disfigurement and rare life-threatening allergic reactions or anaphylactic shock. In some cases, surgical procedures have been required to treat these problems, such as draining abscesses.

Other wrinkle filler side effects have included inflammation, pain at the injection site, numbness, bleeding, blistering, bruising, migration, formation of lumps or nodules and infection. Minor problems, such as a small amount of swelling or redness, are known and expected side effects and are currently described in the product literature.

The FDA is attempting to determine whether additional studies are necessary and whether any updates should be made to the product labeling. Although the FDA is no required to follow the recommendations of their advisory committees, they often do.

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201 comments

  1. Linda Reply

    It’s been more than 11 years since I had Fascian injections into acne scarring. The doctor I was working with refused to give my antibiotics prior to the procedure though I had read that was standard according to the doc that first used the injections. Two days after the procedure I developed large boils and fever on both sides of my face. This carved out large “pockets” and the Fascian slipped down my face – it was no longer under the acne scars. The doctor then prescribed antibiotics but it was too late to rescue my face. It was very lumpy and the doctor said to “massage” and they would go away eventually. They never went away and two years later I had sculptra to fill in the hollows these lumps have created in my cheekbone – my doctor refused to do this at cost in spite of the lumps on my face. Looking back I should have taken him to court, but he kept saying they will be absorbed eventually. I can’t afford the Sculptra upkeep and 11 years later I am left with large lumps on both side of my face. These give me a “hound-dog” look and make me look 10 years older than my age. At least the fact that it was injected so far under my skin means I can only feel the many separate lumps in my mouth. The small lumps formed to make one large lump on each side and I have been told there’s not much that can be done. They are permanent and I have been extremely depressed about them for many years. It will cost a fortune to keep the hollows on my cheekbones filled in. Please don’t do Fascian if you are considering it. These lumps are far worse than the scars I was trying to correct. I realize the statute of limitations has run out on my lumps unfortunately.

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