Oct. 31, 2002 -- American women say they have found the fountain of youth in a syringe, but there's a catch: It's illegal to use in the United States.
Hyaluronic acid, marketed under the names Restylane and Perlane, is tremendously popular in the 61 countries where it is legal to use as a wrinkle filler. It occurs naturally in the body as part of the medium where skin cells live.
And those who have received the treatment rave about their results.
"When I look at myself in the mirror and I don't see the deep grooves … I feel ecstatic and I feel happy," Bonnie Rose, 41, told ABCNEWS' Good Morning America.
ABCNEWS' Dr. Nancy Snyderman says Restylane can be more effective than collagen.
"We've all heard of collagen, an animal substance used to plump up and fill in lines and creases in the face that cannot be smoothed by Botox," says Snyderman. "But collagen comes from cows, and carries about a 3 percent risk of allergic reaction."
Perhaps a bigger downside is longevity. Collagen injections typically last about three months — meaning more visits and more money are required for maintenance.
"Collagen is very variable," says Wendy Lewis, a former longtime collagen user and independent cosmetic surgery consultant in New York City. "It's fine if you are in you're 20s and you just want your upper lip done, but once you get into your late 30s and the line is a little deeper — you find that you're living in your dermatologist's office."
Restylane is what has satisfied Lewis and thousands of others all over the world who wanted an alternative filler without collagen's pitfalls.
And the findings of a clinical trial comparing Restylane to collagen in 137 patients offer promising news that Q-Med, the Swedish-based manufacturers of Restylane, hopes will bring it one step closer to approval by the Food and Drug Administration for use in the United States.
The results, which will be presented today at the 29th annual meeting of the American Society for Dermatologic Surgery, found that hyaluronic acid worked better, lasted longer and required less product than collagen to fill facial lines.
Additionally, this preparation of hyaluronic acid was found to have no risk of allergic reactions. Earlier preparations derived from rooster combs have been associated with inflammatory reactions in the past.
"The products that were used in the '60s, '70s and '80s were very, very different, even though they're hyaluronic acid," says New York City plastic surgeon Dr. Paul Lorenc, who participated in the clinical trial for the FDA. "[Restylane] is a non-animal-derived product."
Crossing the Border
Many American women who want to reap Restylane's benefits, which can last as long as a year, are traveling to countries like Britain where it is legal to use.
Dr. Nick Lowe has been using this new class of injectable fillers for the past six years at his office in London's Cavendish Square.
"One of the puzzles is why we've got all of these fillers available in Europe and why we haven't in the United States," he says. "I think one of the benefits of the American system is the FDA regulations, and the FDA are very, very careful — as they should be — before these products are allowed on the market."
Lorenc has come up with a unique way to satisfy his patients without having to open a satellite office all the way across the pond. He takes them to the Half Moon resort in Jamaica, where women spend their time enjoying a new kind of R & R — Rest and Restylane.
"I think the opportunity for a patient to get away from the hustle and bustle of our daily life, undergo a cosmetic procedure and recover in this idyllic setting is very attractive," he says.
Not all Americans who have had Restylane injections have had to leave the country for the treatment. Some, like Rose, received their injections through participation in studies. But there are others who have managed to tap into a burgeoning underground market.
Dr. James Wells, president of the American Society of Plastic Surgeons, says he has heard anecdotal accounts of illegal Restylane use in this country. "I think this is very risky for the doctors and the patients," he says.
The penalties for the doctor are severe and even career-threatening. If a doctor is discovered distributing a drug that has not been approved by the FDA, the state medical board will be notified, which in turn could result in the doctor's license being revoked.
But that hasn't stopped one prominent plastic surgeon, who wanted her identity hidden, from injecting patients.
"Patients were bringing it from Canada, from Israel, from England … patients of mine who come here for surgery. And I would inject them with Restylane. And the results were very good and longer-lasting," she says. "In fact, I use it on myself … and most of my friends, if they can get it, would love to have it."
A Fantastic Future
Passports and illicit injections may soon be a thing of the past for Restylane seekers. With the results of the clinical trial having been sent to the FDA, hyaluronic fillers — specifically Restylane — will most likely be approved for use next spring.
The American Society of Aesthetic Plastic Surgery counted 592,000 injections of wrinkle fillers last year, a number experts believe will skyrocket upon Restylane's approval.
"I don't think there's any question in the minds of doctors who've had experience using the material that this will revolutionize the wrinkle-filler market in the United States," says Lewis.
"Every woman I know is waiting with bated breath to get her hands on it, and we can't wait until it's FDA-approved. Then we know it'll be readily available."
ABCNEWS' Sarah Adler, Alexa Pozniak and Melinda T. Willis contributed to this report.