It appears that beauty has its price if considering the
latest news for the Food and Drug Administration concerning the use of wrinkle
fillers. The products also called dermal fillers, can be made from animal
collagen or chemicals and are injected into the skin to make it look younger or
to reduce scarring. They first appeared on the market 20 years ago, but the
latest batches have been approved in the last 10 years.
According to the agency’s Web site, more and more people
using them experience medical problems later. A total of 930 reports of health
problems have been received over the past six years (from January 2003 to
September 20th of this year). Side effects include facial palsy and disfigurement
and rare, but life-threatening problems such as severe allergic reactions and
anaphylactic shock. There were also reports of minor swelling, but that is an
expected reaction to the injections.
The FDA did not specify how many side effects were serious
or which were the products linked to them. However, Medicis Pharmaceutical
Corp.’s Restylane, Biofarm Medical’s Radiesse and Allergan Inc.’s Juvederm are
among the top-selling fillers. The FDA review does not include Allergan’s
Botox, a toxin injection, which relaxes facial muscles.
Among the reports, 19 were from people admitted to the
emergency room for severe allergic reactions, 638 patients required treatment
with medication, which included steroids, antihistamines and oral antibiotics. Also,
94 patients required surgical intervention (opening the abscesses, excision of
nodules and biopsy of lesions), which included 44 that had also received drug
therapy. The other reports did not include specific treatments for conditions.
The FDA review was released ahead of a Nov. 18 meeting of
agency advisers in Gaithersburg,
Maryland, to discuss the safety
of the products and whether new warnings are needed. According to the same
review, the agency expects more applications to sell dermal fillers for wrinkles
and possibly for contouring the face and body.
Overall, about 1.36 million women and 84,000 men received
the injections last year, primarily for cosmetic reasons, but they are also
given to HIV patients to counteract a gaunt look. According to the American
Society for Aesthetic Plastic Surgery, non-surgical cosmetic procedures
increased more than eightfold between 1997 and 2007.
Answering to the FDA review, Medicis Chief Executive Johan
Shacknai said, “We do not see any adverse events that are unexpected or unnoted
on our product label. We haven’t seen anything that if life-threatening.”
Also, Allergan spokeswoman Caroline Van Hove said no serious
problems were seen in clinical trials of Juvederm and the most common complaint
since its approval was swelling in 0.4 percent of patients.
“Juvederm has a highly favorable safety profile based on
long-term use and volume,” she said.
An official at Bioform Medical could not immediately be
reached for comment.
