Facial Fillers Need Stronger Warnings

Product labels for facial fillers that seem to provide a magical reversal of aging and its wrinkles need to be revised to warn of the possibility of the chemicals leaving behind blotches, scars and under-skin bumps, an independent panel told the Food and Drug Administration. "This is almost a no-brainer," said panel member Dr. Michael Bigby, a Harvard Medical School dermatologist. "The current label is not adequate."

"Patients don't want to get rid of wrinkles and end up with large bumps on the face instead," said consumer activist Diana Zuckerman, president of the National Research Center for Women & Families. The FDA convenes many panels of doctors and other experts to provide advice on a wide range of drugs and medical treatments. This panel unanimously agreed that more safety studies are required for the gel-like chemicals that are injected into the faces of some 1.5 million Americans a year to smooth away wrinkles.

Fillers have become especially popular with baby boomers, who view them as a virtual fountain of youth, much less expensive than a facelift and needing far less treatment and recovery time. Most manufacturers and plastic surgeons say facial fillers are perfectly safe. In fact, the chemicals have become so popular that they're frequently used for "off-label" purposes such as plumping the lips, cheeks and breasts. And more and more, untrained technicians are giving injections.

Also, there's a worrying lack of long-term safety research. The independent FDA panel scrutinized data on 823 patients - nearly all women and in the 50- to 60-year-old age group - who experienced serious reactions from filler treatments between 2003 and last September. Fully 638 of the patients needed follow-up medical treatment for "serious and unexpected" conditions that included vision problems, facial, lip and eye paralysis, disfigurement and some severe allergic reactions.