Parker, Waichman, Alonso LLP

Home » Articles

Wrinkle Fillers Like Juvederm, Restylane Need Better Labeling, FDA Panel Said

Nov 18, 2008 | Parker Waichman Alonso LLP

The labels of Juvederm, Restylane and other wrinkle treatments known as dermal fillers should better inform users of their risks, a Food & Drug Administration (FDA) panel said today.  The FDA is not bound to follow the recommendation of its advisory panels, but it usually does so.

Dermal fillers like Juvederm, Restylane and others are approved to  treat moderate to severe facial wrinkles.  However, they are increasingly being used off-label in other procedures, such a lip plumping and facial contouring.

Last week, the FDA said it expects to receive more applications to sell dermal fillers for wrinkles and possibly for contouring the face and body. As a result, the agency said it wants to determine whether improvements are needed in the way the products are studied and labeled.

A report published on the FDA website last week found that dermal fillers had been linked to cases of life threatening allergic reactions and anaphylactic shock.  Other problems associated with dermal fillers ranged from mild swelling to  facial, lip and eye  palsy, retina vascular occlusion, infection and disfigurement, the report said.

According to the FDA, 638 reports indicated that patients required treatment with medication, including steroids, antihistamines and oral antibiotics.  Ninety-four reports indicated surgical intervention, 44 of which were among the patients who received drug therapy as well.  Surgical procedures ranged from opening an abscess for drainage of pus, excision of nodules, to biopsy of the lesions, the FDA said.

Many of the side effect occurred in off-label procedures, and could have also been the result of untrained personnel, or procedures done outside of a healthcare setting, the report said. 

According to Bloomberg.com, FDA advisors said today that current safety information for dermal fillers inaccurately describes most side effects as quickly noticeable and temporary. 

`The labeling should be modified to reflect what we're learning further about the products," said panel member Mary McGrath, a professor of surgery at the University of California in San Francisco.

According to the Associated Press, plastic surgeons  attending the meeting pledged to help the government track safety, improve training and provide clearer information to consumers.