FDA Panel Smooths Way for Permanent Wrinkle Remover
Americans anxious to achieve that Barbie doll look may soon get a lift, appropriately enough, from a little plastic filler that can erase wrinkles and poof up their lips like Angelina Jolie’s -- permanently.
An injectable treatment called Artefill, created by privately held Artes Medical Inc. of San Diego, was approved Friday by a Food and Drug Administration advisory panel, whose recommendations usually are adopted by the agency.
A final OK from the FDA would position Artefill in the nation’s $7-billion cosmetic surgery industry as a competitor to popular but temporary face-smoothers such as collagen and Botox. The effects of Artefill are reported to be permanent.
The Artes Medical product is widely used in Europe, Canada and South America under a different name. It only recently completed clinical trials in the United States.
The key ingredients are bovine collagen and microscopic plastic spheres made of a substance called polymethylmethacrylate, which has been used for decades as a bone cement and to make dental prostheses.
If Artefill is injected in a bothersome wrinkle or two, say, those not-so-funny laugh lines, the furrows will fill in immediately. The human body gradually will absorb the bovine collagen and replace it with its own, which forms around the microbeads.
“That’s what gives you the long-term results,” said Mariano Busso, one of the clinical trial physicians.
Despite the excitement about the product, the American Society of Plastic Surgeons on Friday sounded a cautionary note. The organization said that, in some patients, the material can form lumps after it is injected and can cause localized skin reactions such as rashes. Concern also has been expressed that the plastic microbeads could travel to other parts of the body.
Because of its permanence, Artefill “requires greater skill to inject,” the society said.
Artefill has more in common with collagen than with Botox, which reduces wrinkles by relaxing facial muscles. Collagen is a naturally occurring protein found in connective tissues, and injectable collagen is derived from purified bovine collagen.
Collagen’s benefits wear off after two to six months and cost about $333 a treatment, the plastic surgeons association said.
No price has been set yet for Artefill, but the Canadian version costs about twice that of a collagen treatment, said San Francisco cosmetic surgeon James Romano, who also participated in the study.
Demand for such youth-enhancing products is brisk in high-end communities from the star-studded enclaves of Los Angeles to the retirement communities of the Southeast. In some circles, people are throwing so-called Botox parties in which participants drink wine and pony up fees to a doctor who dispenses injections.
“People in Miami are dying for a product like this,” said cosmetic surgeon Busso, chief of dermatology at Mercy Hospital in Miami.
Some participants in the trial received Artefill, while others got collagen injections. Only the doctors knew who got which treatment.
Patients who received collagen injections said they were “very happy” with the results -- but then became disappointed within six months when the benefits diminished. But patients who received Artefill remained “significantly happier” after that period and continued to be pleased at the end of a year.
The prospect of fewer doctor visits is appealing to people who are committed to look younger and prettier by going under the needle or the knife.
Still, Romano said the advent of Artefill does not mean the end of Botox. He says he uses both in combination, depending on the patient’s needs.
Romano thinks that Artefill will be embraced by young men and women with “congenitally very small lips” who want to add a sexy pout to their countenance.
Artefill’s technology has other potential medical indications, including injection treatments for gastroesophageal reflux, stress urinary incontinence and fecal incontinence, said Artes Medical spokeswoman Sarah Chang. Preclinical studies on reflux and urinary incontinence are underway.