Personal Injury Law

FDA Considers Wrinkle Filler's Serious Side Effects

By Jane Akre

The adverse health reports are coming into the Food and Drug Administration and a report issued today on the agency Web site notes 930 side effects connected to the use of wrinkle fillers.

The products are various and include Restylane (Medicis Pharmaceutical Corp), and Juvederm (Allergan).  No word yet on how many of the side effects are serious. They were collected into the agency from January 2003 to September 20th of this year.

Side effects include minor swelling, which might be expected with any injection at the site, an inability to control facial muscles, allergic reactions, and disfigurement.

The reports only cover fillers, not Botox, which relaxes muscles that cause wrinkles to form.

The FDA is convening a panel of experts Tuesday to discuss the overall safety of these products as more are predicted to be approved in the near future. They will consider whether additional warnings need to be added to the product labels.

Wrinkle fillers work by plumping up the skin at wrinkle lines such as around the mouth. They first appeared on the market 20 years ago, but the latest batch have been approved in the last 10 years.

Fillers are made from animal collagen or chemicals.  

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.

Shares of Medicis and Allergan closed down upon hearing the news.  Both companies say they have outstanding safety records. # 

Full post as published by InjuryBoard on November 14, 2008 (boomark / email).