New injection fills wrinkles longer

ArteFill is looking for approval by the FDA.
By SHARI ROAN
LOS ANGELES TIMES
By her early 50s, Dorene Polcyn was growing weary of her battle against Father Time. Every six weeks, she would drive to her dermatologist's office and plop down $375 for an injection of collagen to fill in and smooth away wrinkles on her face.
"The collagen didn't last that long. And I was tired of the expense," says the Los Angeles woman, now 60.
Then, in 1998, Polcyn entered a clinical trial for a long-lasting wrinkle-filler called ArteFill. The difference was striking. Eight years on, she's only recently had to return to her doctor for fresh treatment -- and then just to fill in new wrinkles that have cropped up in the meantime.
"It seems like we stopped the clock," she says. "I love it. I have so many friends who want it."
Dermal fillers -- injected substances that plump up crevasses, wrinkles and depressions in the skin -- already have been encroaching on the venerable face-lift's turf. Now a new generation of longer-acting fillers may turn the temporary fixer-upper, collagen, into a cosmetic dinosaur.
With the Food and Drug Administration set to decide this summer whether to approve ArteFill, the first so-called permanent dermal filler, consumers may shortly have the cosmetic fix of their dreams: a treatment that fills a wrinkle and keeps it filled -- for years.
If approved, ArteFill will join several other longer-lasting wrinkle eradicators, such as Radiesse, a "semi-permanent" filler that is approved for use in vocal cord defects and is already being used off-label by doctors to fill wrinkles. Now its maker is seeking FDA approval to market the injectable for cosmetic use. Sculptra, another long-lasting filler made of synthetic materials, is also being used off-label for treating wrinkles.
And Juvederm -- a filler made of hyaluronic acid -- was recently approved for use. Unlike previous hyaluronic acid fillers, which last about six months, Juvederm is touted to last at least six months and up to a year.
The appeal of these remedies is obvious. "For many patients, permanent is what they're looking for," says Dr. Douglas Hamilton, a Los Angeles area dermatologist who participated in the early clinical trials of ArteFill. "They don't want to keep coming back."
The rise of long-lasting dermal fillers could further energize a market that has already superbly captured America's anti-aging obsession. Demand for shorter-term fillers has skyrocketed in the last few years, despite the cost and inconvenience. The number of injections for the most popular type, hyaluronic acid, soared 35 percent from 2004 to 2005, according to the American Society for Aesthetic Plastic Surgery. It is now the third most popular nonsurgical cosmetic procedure in the United States.
Long-lasting fillers may also hasten the trend away from face-lifts, which declined in popularity for the first time in 2005, according to the society.
The new dermal fillers fulfill several needs: They last much longer -- at least one year compared with three to six months for the earlier generation of fillers. That ends up being more cost-effective for consumers. And they can be used for deeper facial lines and depressions and to add volume to sunken cheeks or smooth a bumpy nose.
Risks
But the expanded uses and addition of long-lasting fillers have raised concerns among some doctors. They say that the marketplace is rife with inexperienced practitioners, injection "parties" in nonmedical settings and counterfeit products -- all of which could lead to botched work including long-lasting, ugly results such as lumpiness or lopsidedness.
Even when injected properly, long-lasting fillers are not easy to remedy should the consumer suffer a bad reaction or dislike the result.
Moreover, no one really knows how long-lasting fillers will look years later as the face continues to age.
"The field is expanding and is getting more complex," says Dr. V. Leroy Young, a St. Louis plastic surgeon and chairman of the nonsurgical procedures committee for the American Society for Aesthetic Plastic Surgery. "People have to be very sure when they sign up that they understand the risks and benefits and what the alternatives are and how they all compare."
How it works
Dermal fillers can consist of human fat, human collagen, bovine collagen, hyaluronic acid (found naturally in the body's connective tissue), synthetic substances or combinations of those materials.
The older, short-acting fillers are made of natural products such as collagen and fat that are quickly absorbed by the body. The new long-acting fillers mostly rely on synthetic materials for that extra durability.
ArteFill, for example, consists of tiny synthetic spheres made from polymethylmethacrylate, a substance used in some types of medical implants, suspended in a bovine collagen gel.
While no one is quite sure how it works, most experts believe that the microspheres settle in the injected site (they cannot be broken down by the body). The bovine collagen gradually disintegrates and is replaced by a permanent scaffold of human collagen growing around the microspheres.
A study of 69 patients showed an improvement in nasolabial folds (the smile lines framing the mouth) lasting at least five years, according to data presented last year at the annual meeting of the American Society of Plastic Surgeons.
Radiesse consists of smooth particles of calcium that, after injection, also form a scaffold that is slowly filled with human collagen. Studies show it lasts for a year to 18 months, although the spheres may last as long as five years before breaking down.
Sculptra, which is approved for lipoatrophy, the facial wasting associated with HIV infection, consists of a synthetic substance called polylactic acid that has long been used in medical products such as dissolvable stitches. It adds volume to skin and lasts about two years.
And Juvederm consists of a higher concentration of hyaluronic acid than found in previous versions and lasts about six to 12 months.
Difficult choices
With this burgeoning of options, consumers and doctors will have many more choices about where to use fillers.
San Diego-based Artes Medical Inc., the maker of ArteFill, for example, is seeking approval only for its use in treating nasolabial folds -- but if approved, it will surely be used in other areas of the face, most likely deep wrinkles, scars and indentations, experts say, as well as upper lip furrows, acne scars, depressed areas under the eyes and even the deep expression lines between the eyes.
Doctors recommend that patients exercise caution to maximize the chance that treatment with long-lasting fillers will go well. The first order of business is to check the injector's experience. "Technique is a big issue here," Young says.
And the key to successful ArteFill, Sculptra and Radiesse injections will be for the physician to tread lightly, experts say. Major problems could occur if the doctor injects too much, injects at the wrong depth or injects in areas of the face that it shouldn't be used in.
For example, in the case of ArteFill, "You have to go slower," says Dr. Nicholas Nikolov, a Beverly Hills plastic surgeon. Over time, the human collagen will grow in and plump out the wrinkle -- so overfilling could lead to bumps.
To be cautious, Young says, patients could try a temporary filler to see if they like the outcome, then use the ArteFill or another long-lasting filler later.
Consumers should also be careful about using any filler off-label or in an area of the face that it is not specifically approved for -- such as with facial shaping, which is becoming ever-more popular.
"When you get it right, it works well," says Young. But, he adds, "The use of these things on the nose is on the riskier side of things. If you get a problem you're going to live with it for a long time and you may need an operation to fix it."