Delayed reactions from popular dermal fillers, injected into the skin for
wrinkle reduction, may be underestimated, putting many women at risk for adverse
events, such as scarring, Bell's palsy, and lumpy faces. According to statistics
from the American Society of Aesthetic Plastic Surgery, Millions of people seek
skin treatments every year from dermal fillers.
The FDA has received 930 reports of side effects from dermal fillers in the past
ten years. Inflammation, allergic reactions, infection, scars, bleeding, and
face numbness associated with Bell's palsy are documented. Many of the
procedures are performed by personnel with inadequate training, compounding the
problem. Dermal fillers can migrate to other area of the face, cause asymmetry.
Other undesirable results include bleeding and bruising. Unfortunately, many
plastic surgeons do not feel that stronger label warnings are necessary.
Siobhan DeLancey, an FDA representative, present at a recent advisory panel
meeting says manufacturers of dermal fillers should be very clear that side
effects can occur years after the popular skin treatments are administered. "A
lot of the panel members say they want manufacturers to do more rigorous
premarket studies", says DeLancey.
Popular dermal fillers include Restylane and Perlane; Restylane has been
marketed for its long lasting properties, making it very appealing for women
seeking to reduce facial wrinkles. The product is manufactured by Medicis in
Scottsdale, Arizona. CEO of the company, Jonah Shacknai disagrees that stronger
labels are needed, stating, "We have not seen an adverse effect not reflected on
our label." Other manufacturers feel warning labels should be specific to the
product, rather than broadly based to include short acting and long acting
dermal fillers.
Plastic surgeon, Toby Mayer, MD who practices in Beverly Hills, California feels
it's the physician's technique that may be to blame, rather than the product.
"Adverse events are more likely to occur when the fillers are used by
inexperienced physicians or others", says Mayer. If dermal fillers are placed
too deeply into the skin, the chances of side effects are greater. That message
may be of major important for any women wishing to use dermal fillers to reverse
the skin effects of aging. Karol Gutowski, MD, chief of plastic surgery at
NorthShore University Health System in Chicago has a differing viewpoint,
saying, "Some of us are concerned about the long-acting ones".
Dermal fillers that have not been on the market as long might carry unknown
effects, making it also important for manufacturers to engage in longer-term
studies, another recommendation from the advisory panel. We should all agree
that consumer education is always a good idea.
