Stronger Warning Labels Needed for Facial Fillers

Consumer activist Diana Zuckerman believes that patients have no desire to replace wrinkles with large bumps or other blemishes on their face. The FDA routinely gathers many panels of doctors and other experts to provide advice on a large range of drugs and medical procedures. The panel unanimously agreed that additional safety studies are needed for the gel-like chemicals that are injected into the faces of some 1.5 million Americans each year.

Baby boomers have become especially enamored with wrinkle fillers. These products are viewed as a virtual fountain of youth – a much less expensive option compared to a facelift and requiring less treatment and recovery time. A majority of manufacturers and plastic surgeons claim that facial fillers are perfectly safe. In fact, some chemicals have become so mainstream that they are even used for certain “off-label” purposes such as plumping the cheeks, lips, and breasts. Unfortunately, an increasing number of untrained physicians are giving these injections.

In addition, there’s a concerning lack of long-term safety research. The independent FDA panel scrutinized data on 823 patients – nearly all women and in the 50 to 60 year old age group – who encountered serious reactions to filler treatments between 2003 and 2007. Approximately 638 of the patients required follow-up medical care to address serious and surprising conditions that included vision difficulties, facial, lip, and eye paralysis, disfigurement, and in some cases, severe allergic reactions.

For individuals who are interested in receiving a cosmetic injectable procedure, there are several simple questions that should be examined.

Concerning the doctor: Is the injectable recommended by a qualified physician who routinely treats similar conditions, in a licensed and properly equipped medical facility? Has the doctor thoroughly evaluated the prospective before recommending a specific treatment?

Concerning the filler brand: Is the injectable recommended by your doctor approved by the FDA and by equivalent agencies in the country of origin? Does the labeling on the product indicate cosmetic applications and is it packaged to reflect its authenticity and approvel?

Concerning Safety: Is the physician’s facility a proper medically-equipped office, with safety and sterilization procedures? Has the doctor examined conditions, suggested treatment, offered alternatives and clearly explained the potential outcomes, including complications?