That Happened!

New York - In a recently released FDA report, wrinkle fillers are linked to serious side effects. Wrinkle fillers are injections of animal collagen or chemicals under the surface of the skin. They are used to smooth and plump skin and lips, reduce scarring, and fill in wrinkles and creases. They are most commonly used around the eyes, nose and mouth. Many people favor them over surgical face lifts because they they are less invasive and give a more natural looking result. The popularity of fillers has increased greatly in recent years. More than two million people had wrinkle filler injections in the past year, most of them women.

According to a recently released FDA report, the FDA has received nearly 1000 reports of severe side effects and unexpected reactions in the last six years. Wrinkle filler manufacturers acknowledge that minor swelling is a common side effect. The FDA has also received reports of severe allergic reactions leading to shock, facial paralysis and disfigurement.

Botox, which is not a dermal filler but a muscle relaxer, was not mentioned in the report. The products for which safety concerns were raised are Medicis Pharmaceutical Corporation’s Restylane, Allergan Inc.’s Juvederm, and BioForm Medical’s Radiesse. The statement released by the FDA does not identify which problems were reported for which fillers.

Makers of the fillers claim they are unaware of any life-threatening injuries or reactions and have released statements asserting that their products are safe. The FDA considers the negative reports it received problematic because they do not always include important information, such as when the users began to suffer the adverse reactions. It is also unclear whether some of the injections that caused side effects were administered “by untrained personnel or in settings other than health clinics or doctors’ offices.”

The FDA is planning to consult an advisory counsel about changing wrinkle filler labeling requirements to alert consumers to the risks. They will also consider changes to the way the products are safety tested. The FDA expects to receive new applications for filler products in the near future for face and body contouring.