Celebrity tabloids and TV shows often critique excessively pouty lips and other cosmetic procedures gone bad amongst the glitterati… but the potential dangers involved in cosmetic procedures such as dermal filler injections go way beyond bad press for the rich and famous. Though these procedures have become commonplace, they are nowhere near as safe as they may seem.
Most recently an advisory panel to the US Food and Drug Administration (FDA) issued a report saying that injectable cosmetic wrinkle fillers may have “serious and unexpected” adverse effects. Current labels on dermal fillers outline reactions such as redness and swelling, but those risks are now understood to extend to severe allergic reactions or disfigurement. The independent panel of experts has issued a non-binding recommendation to the FDA to strengthen warnings on product labels.
Temporary and permanent dermal fillers were approved by the FDA in 1981 for plumping up soft tissue, filling in facial wrinkles and smoothing the skin. They can be made from natural substances (such as highly purified human or bovine — cow — collagen) or synthetic ones. About 1.5 million wrinkle-filling procedures are done each year with products such as Juvéderm, Restylane, Perlane, ArteFill and Radiesse. Many patients require more than one injection to achieve the desired effect, with results typically lasting only six months or so, as fillers are gradually absorbed by the body.
In its review of 930 adverse event reports from fillers over the last five to six years, the FDA classified 823 reactions as “injuries.” These included infection (most common at the injection site)… minor, temporary bleeding… lumps… bumps… and in rare cases permanent disfigurement. Medical intervention was required in 684 of the adverse events, including nearly 100 surgical procedures. Nineteen people visited the emergency room for treatment of life-threatening allergic reactions. The FDA did not specify whether any dermal filler brands were associated with more problems than others.
There is no question that injectable filler procedures have the potential for side effects even when administered by the most skilled physician, observes Audrey Kunin, MD, founder and president of DERMAdoctor (www.dermadoctor.com) and coauthor of The DERMAdoctor Skinstruction Manual. If you choose to take the risk and have this type of cosmetic procedure, she recommends extreme caution — get dermal filler injections only under the direct supervision of a licensed, board-certified dermatologist or a plastic surgeon who is skilled in their use and trained to handle unexpected problems.
Furthermore, the FDA advises against dermal fillers for people who have a history of severe allergies or allergic reactions… are allergic to collagen, eggs or lidocaine… have a bleeding disorder… are prone to scarring… or whose skin is currently infected or inflamed.
Additionally, when considering fillers…
If you experience an adverse reaction to a dermal filler, report it to the FDA’s MedWatch Adverse Event Reporting Program at the above address.
