More Warnings for Derma Fillers
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An FDA advisory panel believes the cosmetics industry is not coming clean about the potential adverse side effects from dermal fillers, injected to soften facial wrinkles.
Popular brands are Juvederm (Allergan) and Restylane (Medicis Pharmaceutical Corp).
The experts who make up the panel agreed the labeling should include more serious side effects, how long the product has been on the market, and how long it might take before side effects appear,” says a FDA spokeswoman.
More than 1.5 million of these procedures are done a year, so it's about time. During the last six years, the FDA has received 930 reports of adverse effects from the numerous dermal fillers approved. They include:
· Allergic reactions
· Swelling
· Inflammatory reactions resulting in nodule formation, cold sores, arthritis flare-ups, and other problems
· Infection
· Bruising, bleeding, scars
· Blisters and cysts
· Lumps and bumps
· Numbness, including palsy
· Migration, such as the filler material moving to another site on the face
A number of the reports of adverse events involved injections by untrained personnel, the FDA also found.
No deaths have been reported, but the panel is concerned that the long-term effects of some dermal fillers may not be completely understood.
While the current labels do include several potential adverse effects, they do not always list when the events might occur. The panel is advising the FDA to require manufacturers to note that some events can occur months and sometimes years after injection.
Some plastic surgeons and industry representatives say stronger labels are unnecessary, while other experts welcome the labeling recommendations. #