Wednesday, November 26, 2003, 10:25 A.M. Pacific

Fighting wrinkles: New products fill the lines of time

By Julia Sommerfeld
Seattle Times staff reporter

In the war against wrinkles, Botox won the battle of the brow. Millions of furrowed foreheads have been poked into smooth submission. But the rest of the face was left crinkled and craggy. That's where a new crop of injectables comes in. Known as wrinkle fillers, they can fill deep facial crevices as well as plump cheeks, chins and lips.

Dermatologists, cosmetic surgeons and middle-agers who aren't amused by laugh lines are anxiously awaiting several new wrinkle fillers working their way through the Food and Drug Administration. Just Friday, advisers to the FDA recommended approval of two of the most widely anticipated fillers, Restylane and Hylaform. Another, called Artefill, was backed by the panel this spring, and now is waiting for the agency's final ruling. The FDA usually follows the advice of its advisory panels.

Two other next-generation fillers have already hit the market: CosmoDerm, which got the government's go-ahead to treat wrinkles earlier this year, and Radiance, approved to strengthen vocal chords but now being used off-label for skin plumping.

This is not just some Hollywood phenomenon. Some Seattle physicians and patients are so eager for the newest wrinkle fixes they're getting a head start and using skin-smoothing shots before the government gives its stamp of approval.

What ever happened to aging gracefully? "Some people say wrinkles are a badge of living," says Seattle aesthetician Nancy Meadows, a recent convert to the new fillers Radiance and Restylane. "But I'm pragmatic, and the reality is in our culture women aren't appreciated for their wrinkles."

The Northwest's outdoorsy, natural-beauty aesthetic may paradoxically draw us toward the needle.

"People here really like a nice natural look, they don't want that surgical, windblown look, so they are really getting into these noninvasive fillers," says Dr. Brandith Irwin, a dermatologist at Seattle's Madison Skin and Laser Center who recently began offering Restylane to patients.

In fact, Irwin's patient Stacie Bowie, a 32-year-old hairstylist at a Capitol Hill salon, had her lips plumped with Restylane to achieve just that fresh-faced Northwest look. "I just wanted to have a little fuller lips so I don't have to wear lip liner and lipstick to look good. I actually look more natural now," she says. "I don't see how this is different from other parts of beauty maintenance; it fits right in there with regular manicures, pedicures and facials."

Trend away from surgery

The mad dash for fillers is helping fuel the trend of cosmetic nonsurgery, a practice pioneered by baby boomers eager to stave off wrinkles but wary of going under the knife. Needles, however, are clearly no problem.

Most injectables, which range from $300 to $1,500 per treatment, give instant results, are relatively safe — side effects are rare and usually temporary — and involve little downtime.

Nonsurgical treatments, with Botox injections leading the way, accounted for three-quarters of the nearly 7 million cosmetic procedures performed last year, according to the American Society of Plastic Surgeons.

Unlike Botox, which paralyzes facial muscles to prevent expression lines, especially on the forehead and between the eyebrows, fillers actually add volume under the surface of the skin to plump up creases, divots and hollows from the inside out. That makes them ideal for spackling the crevices around the mouth and inflating lips and gaunt cheeks, says Dr. Arnold Klein, a professor of dermatology at the University of California, Los Angeles.

Klein, a Beverly Hills dermatologist to the stars, spends about 90 percent of his practice injecting aging beauties. "Between Botox, which is a home run in the upper face, and fillers in the lower face, we have a whole arsenal of minimally invasive cosmetic treatments," he says.

He adds that while Botox has gained a following among businessmen, fillers are still primarily a female phenomenon.

For 20 years, doctors have injected collagen from cows — sold as Zyderm or Zyplast — into wrinkles and thin lips. It works fine while it lasts, which is usually about three months, but about 3 percent of people are allergic to the cow byproduct, and about 1 percent of people who pass the required skin-allergy test can have a delayed sensitivity to collagen and develop lumps, rashes, itching or sores.

The quest for a nonallergenic, longer-lasting filler has yielded some surprising substances, including cloned collagen from newborn foreskins (CosmoDerm), a lubricating fluid derived from the rubbery red crests atop rooster's heads (Hylaform) and synthetic material akin to what makes up bones and teeth (Radiance). Then there's Artefill, made of microscopic plastic beads suspended in cow collagen. Despite FDA advisers recommending approval for the product, it's the most controversial new filler because the plastic microspheres imbed in the skin indefinitely. Though a permanent wrinkle filler was once considered the Holy Grail of cosmetic surgery, doctors are now realizing this is a double-edged sword. If the benefit lasts forever, that means mistakes or bad reactions will, too, warns Klein.

Lynnwood plastic surgeon Dr. Robert Alexander's preferred filler is Radiance because it lasts a long time — an estimated three to five years — but not so long that it will cause misshapen lumps when the face continues to change with age. He injects it into deep crevices and scar depressions.

His patient Kathleen Galbraith, a nurse from Everett, got Radiance injections earlier this month in order to wipe away what she calls the "Fred Flintstone" lines around her mouth. "I don't feel like I'm 41, I'm working out, I'm in better shape than I have ever been, this helps make my outside match how I feel on the inside," she says. "Radiance lasts so long I'll have one less thing to worry about for a long time."

Each of the new fillers has certain advantages over cow collagen and each has a following, but if Canada, Europe or South America, where these products have been available for years, are any prediction, the hottest new wrinkle filler will turn out to be Restylane.

At the annual convention of the American Society for Plastic Surgeons in San Diego last month, posters and computer terminals were emblazoned with a sponsor's message: "Restylane ... Coming Soon."

But some Americans are tired of waiting.

R&R in Canada

Dr. Andrew Denton, director of facial plastic surgery at Vancouver General Hospital in Vancouver, B.C., says about 10 percent of his patients come up from Washington for a little R & R: Rest and Restylane. He predicts once Restylane is approved in the U.S., it will take over the market, just like it did in his practice. But he hopes that since the Canadian dollar makes his services more affordable, he'll keep his American clientele.

One of Denton's patients, Marlene, a 37-year-old Seattle advertising executive who asked that her real name not be used because "my husband would never approve of the expense," drives up to Vancouver about once a year for the $400 (Canadian) Restylane injections into her smile lines.

The lines, she says, formed what looked like parentheses around her mouth and made her look drawn, which she feared was a detriment to her career. "The ad business is very youth-oriented. If you look worn out, tired and stressed, people aren't willing to take you on. You have to look as though you have a lot of energy and vitality," she says.

Restylane, like its competitor Hylaform, is made of hyaluronic acid, a sugar-based lubricant present in humans and most other organisms. Restylane comes from hyaluronic acid produced by bacteria in the lab.

There's very low allergy risk to the hyaluronic acid in Restylane — about one in 5,000, according to Dr. Mitchell Wortzman, chief scientific officer at Medicis Pharmaceutical Corp., the injectable's U.S. distributor. Clinical studies presented to the FDA last week show in most people Restylane lasts six months, at least twice as long as cow collagen. Denton finds it lasts about six months in lips and eight months in wrinkles, and says it's his favorite because it looks softer under the skin than most fillers.

Marlene is not worried about using a product that is not yet approved by the U.S. government because "if it's good enough for Canadians, I don't see why it wouldn't be safe for us," she says.

Some Seattle practitioners see it the same way — or fear they're going to lose business to our northern neighbors — and are beginning to offer Restylane in their offices to select patients.

Lunchtime lift

A couple of weeks ago, Nancy Meadows spent her lunch break baby-boomer style, reclining on a plastic surgeon's table with a syringe full of Restylane being pumped into her already taut skin. Because of her flawless skin and artfully applied makeup, it's impossible to gauge her age.

She's used cow collagen for two decades — "I should be mooing by now," she jokes — but has switched over to the new fillers, Radiance to unfurl deeper grooves and Restylane to top off surface lines. The arsenal of fillers, she hopes, will help stave off the day when her "face falls to the floor."

"Nurse injector" Maryln Wilson, who peddles a buffet of fillers in Dr. Kenneth Tucker's practice at Seattle Head, Neck and Plastic Surgeons, explains Meadows looks so comfortable because she first injected her with local anesthesia. Without the nerve block, shots of Restylane can be excruciating, she warns.

After about 20 passes with the needle, the creases dragging down the corners of Meadows' mouth have vanished, leaving just a trail of pinpricks in their place. Wilson beams at her handiwork causing nary a pucker around her own mouth, thanks to her own recent session with another filler, CosmoDerm.

While it is a violation of FDA regulations to import and use a medical device — a category that includes wrinkle fillers such as Restylane — that hasn't been OK'd by the agency, it's not likely Wilson or other practitioners offering it will get in trouble. The FDA doesn't regulate individual doctors' use of medical devices unless they are widely marketing them. And the Washington State Medical Quality Assurance Commission, which regulates doctors, says it would be hard-pressed to do anything unless patients were being harmed. Plus, with it looking as though the FDA will approve Restylane someday soon, the issue may soon be moot.

"I wouldn't be doing it unless I thought it was the best form of treatment for my patients" says Wilson, who adds that she has her patients sign a consent form stating they understand the product hasn't been approved yet.

Seattle dermatologist Dr. Irwin also stands by her decision to offer Restylane to select patients because she thinks it gives a more natural appearance and is safer than collagen, which she's seen cause allergic reactions in rare patients. "Safety needs to be our primary concern, particularly in the cosmetic realm," she says.

James Rich, medical consultant for the commission, says he'd advise health providers to steer clear of Restylane or other devices that haven't been approved by the FDA.

Meadows is unfazed that the goo erasing her wrinkles is not yet legal in this country. She powders away the needle-prick marks, fluffs her platinum hair, smoothes her fitted sweater and is ready to head back to work as an aesthetician at a swank downtown salon.

"I have no desire or illusion that I'm going to look 20, but I want to look as good as I can at the age I'm graced with," she says. "And, to me, this is what 61 looks like."