The Goo (FDA), the Bad (wrinkle fillers), and the Ugly (930 users)

William Atkins
Sunday, 16 November 2008 19:28

Science - Health

Officials with the Food and Drug Administration (FDA) report that the goo in wrinkle fillers can have ugly side effects including swelling, allergic reactions, infections, and even life-threatening complications.


These injectable wrinkle fillers, which include Juvederm (sold by Allergan) and Restylane (on the market by Medicis), have been reported 930 times to the FDA since 2003 as causing either "serious" or "less severe" problems in users.

The FDA first approved wrinkle fillers over twenty years ago. However, most of them currently on the consumer market have been approved within the last ten years.

For example, Sculptra (poly-L-lactic acid (PLLA)), manufactured by Dermik for Aventis, was approved by the FDA for the treatment of facial fat loss (facial lipoatrophy) on August 3, 2004. It has been called a “liquid facelift.”

Approximately 1.36 million women and 84,000 men received wrinkle fillers in 2007. [Bloomberg: “Wrinkle Fillers Linked to `Serious' Side Effects”]

Thus, only a very small percentage of wrinkle filler users have officially complained about them to the FDA. However, it is wise for all possible users of dermal fillers to be aware of the possible complications of these products.

The report (pdf file) by the FDA, called “Executive Summary: Dermal Filler Devices,” does not state which wrinkle fillers were reported by consumers and does not place a direct link between the anti-wrinkle products and the side effects.

The FDA stated in its Report that these are the approved dermal fillers (and their manufacturers) in the United States:

•    Artefill (Artes Medical)
•    Radiesse (Bioform Medical)
•    Sculptra (Sanofi Aventis Pharmaceutical)
•    Restylane, Perlane (Medicis Aesthetics Holdings)
•    Zyderm, Zyplast (Allergan)
•    Hylaform, Hylaform Plus (Genzyme Biosurgery)
•    Cosmoderm, Cosmoplast (Allergan)
•    Juvederm 30, Juvederm 30HV, Juvederm 24HV (Allergan)
•    Evolence (Colbar Lifesciences)
•    Elevess (Anika Therapeutics)

Page two discusses the FDA report.