That Happened!

New York - Wrinkle fillers have been on the market for 20 years, under FDA approval. Recently, wrinkle fillers also known as dermal fillers have been linked to serious side effects which range from mild allergic reactions to facial disfigurement. The FDA is currently investigating 930 reports, filed over the past six years, of such adverse reactions. This is compared to over 1.4 million users last year alone.

Women are the primary users of wrinkle fillers. Traditionally, the injections have been taken to lessen the prominence of facial lines, but more recently have been used for general body sculpting. Some wrinkle fillers are animal collagen, while others are synthetic chemicals. Popular brands are Juvederm by Allergan, Inc, and Perlane and Restylane by Medicis.

The FDA plans to meet with independent panelists on Tuesday, November 18, to discuss possible changes in the labeling of the wrinkle fillers now linked to causing serious side effects.

Some of the adverse reactions are mild and predictable, such as swelling at injection sites. Other, more serious problems include prolonged swelling, palsy of the lips, eyes, and other facial tissue, infections, vascular blockage of the retina, disfigurement such as permanent swelling and discoloration, and even anaphylactic shock, which can be life-threatening. No information was available as to which particular brands of wrinkle fillers are linked to the serious side effects.

Although some of the reactions from patients were poorly described and lacked merit, most were valid side effects. Medication was required to treat 638 of the patients, while 94 underwent surgical procedures. Medications given were primarily antihistamines, steroids and antibiotics. Surgical procedures includes such things as biopsy of lesions, removal of nodules, and opening abscesses.

There were 19 emergency procedures for more life-threatening side effects. These reactions included a swollen tongue, labored breathing and anaphylactic shock.

Of the approved wrinkle fillers on the market, most have been approved in the most recent 10 years, and the FDA expects more applications. Body sculpting, in particular, is becoming increasingly popular. The agency is concerned that appropriate improvements are made to product labels, and in the way the product uses are studied.