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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.
dr. hoenig
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