FDA panel wants warnings on facial fillers
A panel of government health advisers urged the Food and Drug Administration (FDA) to revise information for consumers and doctors about facial fillers, which are injected into the face to smooth away wrinkles. According to the article in the Philadelphia Inquirer, they want the product label to include the risk of long-lasting reactions such as bumps under the skin, blotches, and scars.
Wrinkle fillers are injected and include such products as Juvederm, made by Allergan, Inc., and Restylane, from Medicis Aesthetics Holdings. Most patients get a couple of touchups a year, which may cost more than $1,000 each.
Manufacturers and plastic surgeons say fillers have an excellent safety record. But the FDA hearing questioned unapproved uses, untrained technicians giving injections, and a lack of long-term safety data. The FDA is considering whether to regulate fillers more closely.
FDA officials are concerned that fillers are being used for purposes they were never tested nor approved for, such as plumping the lips, cheeks, and breasts.
According to the article, plastic surgeons performed some 1.5 million cosmetic surgery procedures with fillers last year alone.
The FDA presented data on 823 patients who suffered serious reactions after treatment with fillers between 2003 and this September. Nearly all were women, and the most common age group was 50- to 60-year-olds. A total of 638 of the patients required follow-up medical treatment.
Most cases reported to the FDA involved complications such as swelling and redness. However, there were also "serious and unexpected" reactions, including facial, lip and eye paralysis, disfigurement, vision problems, and some severe allergic reactions.
Nineteen patients went to the emergency room with life-threatening allergic reactions. Twelve developed infections that required hospitalization.
Some problems reported to the FDA may be due to unapproved or "off-label" use of fillers. For example, the FDA does not recommend them for plumping the lips, but some doctors see no problem with that.
Most fillers are eventually absorbed into the body, but one type contains tiny, round, smooth plastic particles that the body does not absorb. Some are made from natural substances and others are not, which means they may react differently in the body.
As a consumer, you have the right to assume that products you purchase or use have been produced in a manner that would ensure that they are safe and free from unreasonable risks. If a company manufactures a product that is hazardous to the user, the company must be held liable for any injuries or fatalities that occurred due to the defective product.
If you have a defective product claim, you will require the representation of a Philadelphia Pennsylvania products liability attorney from Cherry Fieger and Marciano, LLP to handle all of the complexities involved with this type of case.
