About 1.5 million people (1.36 million women and 84,000 men) in the U.S. used dermal fillers last year to smooth facial wrinkles.
However, since 2003, the U.S. Food and Drug Administration received 930 reports of side-effects for products made by various companies.
Some people who were treated with wrinkle filling injections reported “serious and unexpected” side-effects such as the inability to control their facial muscles.
The Food and Drug Administration advisory panel recommended yesterday that dermal fillers include labels that warn people of potential side effects such as tissue damage or scarring.
Current labels only warn about immediate side effects such as minor swelling. The panel now recommends stronger warnings that these injections could include adverse reactions months or even years later.
It was not revealed which products caused specific reactions.
Dermal fillers are very popular among people looking to plump up wrinkles between the cheeks and nose. Popular fillers include brand names as Restylane and Juvederm.
The adverse effects reported to the FDA were:
- Allergic reactions
- Swelling
- Inflammatory reactions
- Infection
- Bruising, bleeding, scars
- Blisters and cysts
- Lumps and bumps
- Numbness, including palsy
- Migration of the filler material
Some side effects involved injections by untrained personnel, the FDA also found. Also, some products are being used outside of approved indications, such as being injected into lips.
The FDA isn’t required to follow the recommendations of its advisory panels, but it typically does so.
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