FRIDAY, Sept. 19, 2003 (HealthDayNews) -- For years, Botox and collagen have been the treatments of choice for women and men looking to banish unwanted wrinkles and frown lines.
But a new generation of safer, better, longer-lasting skin smoothers is set to join the arsenal of aging Americans -- think baby boomers -- who are eager to look as young as they feel.
Three new anti-wrinkle serums that are injected into the skin are nearing U.S. Food and Drug Administration approval. And a fourth isn't far behind, doctors reported Wednesday at a New York City conference sponsored by the American Society of Plastic Surgeons.
All four treatments are already approved for use in Europe.
"There has been continual improvement in the science," said Dr. James Wells, president of the American Society of Plastic Surgeons (ASPS). "We know more about allergic reactions, surgical techniques have improved, and we have more outpatient surgery, which is safer."
The benefits to the patients are that the new products last longer and are therefore more cost-effective. And their efficacy delays the need for more invasive surgeries like facelifts, he said.
Currently, injections of Botox -- a form of botulism toxin -- and collagen -- the main protein of connective tissue -- are the most common methods to smooth away wrinkles. Botox paralyzes the facial muscles that are normally used in squinting, thereby reducing wrinkling. And collagen injections replace collagen lost in the aging process, helping to plump up wrinkles. The effects last for about three months with Botox and up to six months with collagen. Last year 1.5 million Americans underwent these procedures, both of which have FDA approval, according to the ASPS.
The new products are better not only because their chemical components reduce the risk of allergic reaction, but their effects last longer, too, the doctors say.
Two that could receive FDA approval this fall are composed of hyaluronic acid, a naturally occurring component of connective tissue. One, a synthetically manufactured product available in two forms, called Restylane and Perlane, promises effects that last up to a year, said New York City plastic surgeon Dr. Z. Paul Lorenc. Restylane is for fine lines, and Perlane is for deeper skin folds.
In a study of 134 people comparing Restylane with a popular form of collagen called Zyplast, Lorenc found that after six months 57 percent of the participants preferred Restylane, 33 percent thought both products performed equally well, and 9.5 percent preferred Zyplast.
The other hyaluronic acid-based product about to be reviewed by the FDA is called Hylaform. It is extracted from rooster combs, and lasts for between three and six months, according to the ASPS.
Another new product is called Artefill. It has received preliminary FDA approval, and is sold under the brand name Artecoll in Europe. It is billed as a permanent way to assure smooth skin by injecting a combination of collagen and non-silicone polymers at wrinkle sites.
These so-called "microspheres" don't get absorbed into the body. Rather, the body forms collagen around them, according to Dr. Gottfried Lemperle, a plastic surgeon at the University of California, San Diego. He is a consultant to and shareholder of Artes Medical Inc., of San Diego, which manufactures Artefill.
"We inject plastic spheres that act as a scaffold for the body's own collagen, and the spheres stay in place held by the patient's own tissue," he said.
The downside is the chance that patients will get nodules -- hard bumps -- around their lips, which then must be treated, Lemperle said. Also, there have been some reports that the spheres moved from the injection site, and also caused redness. Lemperle claimed these side effects weren't due to the product itself, but because the doctors performing the procedures were not properly trained in its use.
"It is important that the injection be done with expertise. Doctors will have to attend training courses to learn how to do it," he said, adding those courses are one of the conditions required by the FDA before approval becomes final.
Another, semi-permanent soft tissue filler moving toward approval is called Radiance, said Georgia plastic surgeon Dr. Miles Graivier. It is already FDA-approved for vocal cord paralysis and urinary incontinence. The product, reported to last from two to five years, consists of calcium particles that are made into a paste and injected under the skin. There, the body forms collagen around the calcium microspheres and smoothes out wrinkles.
"Thirty-five hundred patients have been treated" with Radiance, said Graivier. He reported that in two-year, follow-up studies in Italy and 16-month reviews in the United States, side effects included some swelling and bruising. And in 10 percent of patients, nodules that formed around the lips required further treatment.
None of this beauty comes cheaply. Health insurance companies usually don't cover cosmetic procedures. And one cubic centimeter of Radiance, the amount needed for a standard procedure, can cost the patient between $1,200 and $1,900, Graivier said.
But people with discretionary income are willing to spend to look better, the same way they get their hair colored or pay for other beauty regimens, said Dr. Caroline Glicksman, a plastic surgeon in Sea Girt, N.J., who is not affiliated with any of the new injectible products.
"These new generation of fillers may last longer and offer alternatives for patients, because not one product is good for every patient," she said. But, Glicksman adds, she won't use them until they've been FDA-approved.
"I see my patients in the supermarket, and my husband plays golf with their husbands, and I don't want to see harm done," Glicksman said. "I really care about safety, so until it's been used for a while, I won't recommend them."
The Mayo Clinic discusses cosmetic surgery. The American Academy of Facial Plastic and Reconstructive Surgery explains some of the terms used to describe cosmetic treatments.