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Just a little jab will do ya'

By Kathleen Louden
Special to the Tribune

October 8, 2003

At cosmetic surgery offices around the country, patients are on waiting lists to get wrinkle-smoothing injections, but not with Botox. It's Restylane they're after, a Swedish-made gel for filling facial wrinkles, which is being touted as a nearly ideal injectable for revitalizing older faces.

Restylane promises to be the next craze in the anti-aging fight, as women over 35 seek ways to turn back the clock without going under the knife. The wrinkle reducer is under review by the Food and Drug Administration, which is expected to approve it this fall. It already is sold in Canada and many other countries.

One way to get this hot cosmetic commodity in the U.S. was to participate in the now-completed nationwide clinical trial of Restylane, whose results were published in June in the journal Dermatologic Surgery.

New Yorker Arlyn Blake volunteered to get the facial injections because, the 66-year-old journalist said, she wanted to look younger and continue working in a youth-dominated industry. Eager to reduce irritation from the shots she received on her lunch hour, she sat in the waiting room with makeshift ice packs--ice-filled surgical gloves.

"It looked like I applied udders to my face," she said.

Lest you think beauty doesn't come easy, Blake said the injections were a quick and easy way to improve her looks. She returned to work without any puffiness and said she was thrilled with the results, which were immediate and lasted more than a year. Lines around her mouth had made her look tired, she said, but Restylane gave her a "fresh, more pleasant" appearance.

In Blake's opinion, Restylane is worth the hype it's getting, and scientific data seem to agree. Results of the clinical trial showed that Restylane caused minimal side effects and no allergic reactions and lasted twice as long as bovine (cow) collagen, the most popular soft-tissue filler until now.

`The best so far'

Compared with collagen and other soft-tissue fillers he has used during 15 years in practice, Dr. Z. Paul Lorenc, an aesthetic plastic surgeon in New York City, said, "Restylane is the one I've been the most excited about." Lorenc, a clinical assistant professor at New York University who participated in the multicenter study of Restylane, added, "It's not perfect, but it's the best so far."

Unlike Botox, a toxin that relaxes the muscles that cause expression lines and thus is not a filler, Restylane gel creates volume that lifts wrinkles. It is made of hyaluronic acid, a natural moisturizer that occurs in the body, including skin and joint fluid.

Because Restylane is not animal-based, it does not require allergy skin testing beforehand, as does bovine collagen. (Bovine collagen has an approximately 3 percent chance of causing allergic reactions, but new human-based collagens do not require skin testing.) That means patients can get Restylane shots without waiting for two test results. In results, Restylane also comes out ahead of collagen, lasting up to a year versus three to four months for collagen.

Restylane most often is injected into the nasolabial folds, the grooves extending from the nose to the mouth. The product's manufacturer makes two other forms of hyaluronic acid: Restylane Fine Lines and Perlane, the latter for correcting deep folds and making lips fuller.

Cosmetic surgeons are studying the use of Restylane in the lower part of the face combined with Botox in the upper face. Together they form what Lorenc called "a facelift by syringe."

But Restylane will not replace Botox, he and other doctors predict.

"They are totally different," said Dr. Jeffrey Dover, a Boston-based dermatologist and associate clinical professor of dermatology at Yale School of Medicine. "It's like a boat manufacturer saying, `Buy a boat; get rid of your car.'"

Still, one woman who has received both Restylane and Botox injections said the hyaluronic acid looked more natural. Diana Keough, 53, of Haverhill, Mass., had lines around her lips injected with Restylane in May. Because Restylane has no anesthetic in it, her dermatologist first numbed the area with an anesthetic cream.

"It's more painful than Botox, but I think the results are better," Keough said. "I'm recommending it to all my friends."

Restylane is no magic wrinkle eraser, though. It's temporary. And, as Keough said, "None of this stuff makes lines go away; it makes them [look] better."

Black-market Restylane

Restylane is not expected to win FDA approval before late November, Dover said. However, demand for it is great, especially in Hollywood. Dr. Jonathan Hoenig, a Los Angeles cosmetic surgeon, said he has more than 100 patients waiting for Restylane to become available.

"I think it's going to be the next Botox in terms of popularity," Hoenig said. "And I think it's going to replace collagen."

Some Americans cannot wait to get their hands on Restylane, or rather, get it in their faces. They're traveling to countries where Restylane is sold or going to doctors who obtain the product outside the U.S. and inject it here.

"There is a black market for this drug," said Dr. Loren Schechter, a plastic surgeon in Skokie and director of plastic surgery at Lutheran General Hospital.

In Illinois, it is not illegal for doctors to use a non-FDA-approved medical device, according to a spokesman from the Illinois Department of Professional Regulation, the agency that regulates Illinois physicians. But Schechter called the use of Restylane before it gets the FDA's OK inappropriate in the U.S. except in clinical studies. He advised patients to wait for FDA approval before seeking Restylane injections and to go to a licensed, trained physician.

Beverly Young is willing to wait. The 58-year-old Chicago grandmother is looking forward to FDA approval of Restylane so she can have the lines around her mouth softened.

"This appears to be an easy, safe procedure," Young said.

Young said wanting Restylane injections has nothing to do with being unhappy with the way she looks. "If you can easily improve your appearance, why not?" she asked.

Apparently, many people feel the same way. More than 1 million Botox (botulinum toxin) injections were performed in the U.S. last year, according to the American Society of Plastic Surgeons. Nearly half a million collagen and fat injections found their way into the thinning lips, wrinkles and creases on American faces.

If Restylane gains the popularity of the mighty Botox, can we expect to see the equivalent of Botox parties--social events where people get the cosmetic injections, sometimes outside of doctors' offices?

Maybe so, but Beverly Young won't be munching nachos while waiting for her shot at Restylane. She said, "I believe in going to the doctor, where it's the proper place to have injections."

A close-up look at Restylane

Description: A Swedish-made injectable skin filler, with a smorgasbord of cosmetic surgeons and patients singing its praises for making wrinkles flatter than a pancake. It's made of a synthetic form of hyaluronic acid, a naturally occurring substance in the body.

Areas used: Primarily used in the folds from the nose to the mouth (nasolabial folds) and from the corners of the mouth to the chin (marionette lines). It also can be used for smoothing other facial wrinkles and for lip enhancement.

Duration: Six to 12 months.

Safety: "Very safe," said plastic surgeon Dr. Z. Paul Lorenc. As with any injection, swelling, bruising, redness and tenderness are possible. Other negative effects, including allergic reactions, reportedly are rare.

Cost: The price is expected to be slightly higher than for collagen, which costs $400 to $500 per treatment.

Availability: A decision by the FDA on whether Restylane can be marketed in the U.S. is pending.

--Kathleen Louden


Copyright © 2003, Chicago Tribune

Considered an expert in facial cosmetic and reconstructive surgery, Dr Hoenig has completed three separate fellowships to ensure that he is qualified to offer the most advanced techniques in facial surgery: cosmetic and dermatologic surgery, oculo-facial cosmetic surgery, and oculoplastic surgery. He is one of the few cosmetic surgeons who is a diplomat of the American Society of Ophthalmic Plastic and Reconstructive Surgery (ASOPRS) and the American Board of Cosmetic Surgery, as well as board certified by the American Board of Ophthalmology.

Toll Free: 866-HOENIG-9 • Local Phone: 818-501-4550
Website: www.faceexpert.com • Email: Info@drhoenig.com

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