Steven Victor has always kept his office stocked with the finest array of body-perfecting, youth-prolonging equipment and technologies a cosmetic dermatologist could desire. Some things, like the microwave hair-removal machine, went out the door as quickly as they came in. So a few people temporarily had grid marks across their bikini areas—hey, that’s the price of experimentation. But no one can say Victor’s not in the vanguard. Sitting in a chair in his office overlooking Madison Avenue, he brushes back his shoulder-length white hair and grouses about his profession’s current imbroglio.
“By the time Restylane gets approved here, nobody will be using it in Europe anymore,’’ he says. “People have been using it in the U.S. for four years and in other countries for nine. We’ve been hearing forever that it’s getting approved by the FDA any day.’’
Victor’s patients are a savvy and demanding lot who are almost as up on trendy beauty innovations as he is. Why, he asks, should he have to wait for the FDA to approve something that’s already widely available to patients in Europe?
His focused expression shoots into a wide smile as he plays with a fresh vial of what he claims is the hottest new wrinkle eliminator. “Matridex fills instantly and loses only between 30 and 50 percent of its correction, while Restylane dissipates in six to nine months. That’s pretty cool.’’
Matridex is even further away from being approved than is Restylane; in fact, it hasn’t yet been presented to the Food and Drug Administration. But that isn’t stopping Victor from using it. And he’s not alone.
Though not all of them will discuss it openly, a startling number of cosmetic doctors in the city are using methods and medicines that are not approved for cosmetic purposes in the U.S. Yet these same substances are widely embraced in Europe and South America—the cradles of cosmetic surgery. Many American doctors increasingly see themselves as part of the international community, and resent the lumbering FDA-approval process. While there is deep disagreement over the ethics and safety of using unapproved products, the demand for youth-enhancing substances is so high that there’s a constant hunt for new and improved fillers that last longer and look more natural than old-style injectables like collagen. And, prompted by the clamor from patients for the hottest new products, many doctors are happily administering them.
“We get these things because they are the best,” says Victor. “It’s not like we’re making them in the bathroom or the basement,” he adds. “We get them from international pharmaceutical companies. Am I breaking the law? It’s a gray zone.”
Physicians justify this position by invoking what they call the “standard of care”—the idea that if many doctors engage in the same treatment, it becomes ethically legitimized. They finesse the lack of FDA approval in two ways.
One is to use cosmetically a substance that has been approved only for a medical use. This is called “off-label,” and it’s legal. Botox, originally approved for relieving eye twitches, was used off-label for years before it was approved in 2002 as a wrinkle relaxer—though only for the glabellar lines, the furrowed frown between the eyes. Levulan, FDA-approved to treat precancerous growths, is being used for hair removal and to combat photoaging; hypertonic saline solution, used to induce abortion, is being injected into unsightly veins; and liquid silicone, which is approved for treating detached retinas, is being used as a permanent filler, even though it has been known to migrate from the injection site and cause hard granulomas, or bumps, under the skin.
The other way doctors detour the issue of FDA approval is to use drugs that haven’t even been presented to the agency for consideration.
To hear some doctors tell it, client demand pushes physicians to experiment with unapproved treatments. “There’s a new kind of patient out there,” says Stephen Bosniak, an ophthalmic plastic surgeon at New York Eye & Ear Infirmary. “They come in asking for these things. In this competitive market, people want to be the first to offer something new, because it is exciting.”
But Thomas Romo III, director of facial, plastic, and reconstructive surgery at Lenox Hill Hospital and an officer of several peer societies in New York, is of the opinion that doctors shouldn’t use unapproved treatments. “Either we respect the laws or we don’t,” he argues. “We’ve just come out of Wall Street and banking scandals where people were breaking the law and everyone winked at it—a societal process which has already ruined one industry. When the FDA says something is not approved at all, it’s not ‘sort of’ against the law if you use it, it is against the law.”
Romo believes physicians who are “sneaking it in or bootlegging these things” should have their licenses reviewed. “I told that to the head of Q-Med, which makes Restylane,” he says. “If it was really necessary for patient survival, like a cancer-curing medicine, maybe one could wink at it, but this is to fill in a crease. What makes these doctors feel they are above the law?”
As it happens, Bosniak rents an office in Romo’s suite—and Bosniak has been using Restylane on his patients for seven years. “I realize we are under one roof and have a radically different approach, but patient safety is paramount,” says Bosniak. He used Restylane in animal studies and then at a clinic in Brazil, where it is approved, before injecting it into his patients in the U.S. Still, Bosniak is not an unequivocal off-label advocate. He says he’s seen how “even a minor complication can be horrible for a good-looking, healthy person who comes in to look better. I’ve treated people who have used fillers from Europe that produced terrible lumps, eroding the surface of the skin and producing big, ugly sores. I’ve had a lot of people asking for the new filler Artefill, but there are complications with that one, and I don’t think the FDA will ever approve it.’’
Artefill contains acrylic beads suspended in collagen that harden under the skin; according to several New York doctors, patients have been coming in after a few weeks asking for the affected tissue to be repaired. That can’t always be done, though in some cases cortisone injections can help. In a way, patients whose problems with fillers appear early are lucky, because problems that develop over a long period of time tend to be more difficult—if not impossible—to repair.
“There have been problems with semi-permanent fillers in Canada and Europe,” says cosmetic dermatologist Neil Sadick. “People are developing persistent nodules under the skin. They become hard, visible, and inflamed, and many of these reactions can occur years later. I would wait a couple of years before using any new product that’s permanent or semi-permanent on patients.’’
It’s not only soft-tissue fillers that patients are clamoring for. The elimination of fat, the other aesthetic obsession, has created its own black market.
In one of Steven Victor’s examining rooms, a patient lifts her shirt to reveal defined stomach muscles. “I swear my stomach went down a size,’’ she says, eyes wide. She has gone through a series of injections of Lipostabil, a fat melter that has not been approved for any use by the FDA.
Not only has Lipostabil not been presented to the FDA, but Aventis, the pharmaceutical company that makes it, says it hasn’t been approved anywhere in the world for cosmetic use.
Victor has his own version of the substance, which is basically lecithin, a fat emulsifier, made in a local pharmacy. “I can’t bring in Lipostabil,’’ he says with a smile, “but I can compound anything I want.’’
The stereotype in the city is that cosmetic dermatologists are more willing, perhaps too willing, to use non-FDA-approved treatments on their patients than are plastic surgeons. “Three different patients came to me this summer with vials of Restylane in their purses and asked me to inject them with it,’’ says a prominent Upper East Side plastic surgeon who asked not to be named. “I told them to go down the street to one of the dermatologists.’’
To which dermatologist Soren White replies, “Plastic surgeons like to make our ethics or skills look questionable.” White runs SkinKlinic, a spa that has long administered Botox and Restylane. “But my friends who are plastic surgeons are always asking me about the latest fillers.”
Thomas Loeb, a plastic surgeon who is heading a clinical study on Restylane, says that doctors should be slow to use anything that’s not approved—and that FDA approval isn’t even necessarily the last word. Just because something is given the go-ahead by the FDA, he says, “doesn’t mean that I approve of it. Look at Radiance,” an injectable substance made of bone matrix. “People get hard knots in the lip from it.”
At the Longevity Lounge on West 74th Street, run by a group of doctors dedicated to antiaging treatments, a client is effusing over her personal experience. “I had a double chin; now I’m sculpted,’’ she says. Lionel Bissoon, an osteopath, has given her mesotherapy, a series of hundreds of injections into the skin, and the fat immediately beneath it, that are meant to lift the face and eliminate excess fat. “I’ve had four meso-lift treatments done to my face, and I’ve had Thinjections!’’ she says. “Mesotherapy is the hottest thing in Europe. You know, people in Paris have no cellulite. Of course, you have to diet and exercise, too.’’
The injections used in mesotherapy vary from vitamin mixtures to cocktails containing asthma drugs and caffeine. While many of the ingredients are off-label, the combinations themselves are not approved by the FDA. This does not stop the doctors; in fact, many hype their recipes as proprietary.
This is dangerous, says Robin Ashinoff, head of cosmetic dermatology at Hackensack University Medical Center. “You could risk injuring someone by injecting too much of something. Batches vary, and you don’t have a clear idea of what you are injecting or where it is going.”
Polidocanol, used to eliminate leg veins, is another drug being used without approval, but Ashinoff prefers to stick with the off-label hypertonic saline. “People love polidocanol, and it may have fewer side effects than the stuff that is approved, but I like to be conservative,” she says with a shrug. “I do use off-label drugs, though, because I feel if we don’t push the envelope a little, we’re never going to advance or learn new techniques.”
Therein lies the central tension of the dilemma. When so many doctors used Botox off-label, it surely encouraged the FDA to approve it for cosmetic use. Yet, as Neil Sadick points out about polidocanol, “in cases where side effects have occurred, how do you explain to the patient your use of something unapproved? You’re more susceptible to legal action if the patient has an adverse reaction.”
The fear of malpractice suits seems to be the most potent deterrent among doctors who consider using unapproved drugs on their patients. They’re certainly not afraid of the FDA, which they say is too understaffed to investigate and is under enormous pressure from pharmaceutical lobbying interests to approve these substances. When asked to comment for this story on the issue of off-label and unapproved cosmetic-drug use, an FDA spokesman said only, “We can’t comment on any substance that is not approved by the FDA.” Only if there are problems, says Loeb, will the agency step in.
“The first couple of years of using something, you can look like a hero,” says Jamé Heskett, a family practitioner and the owner of Wellpath, a Madison Avenue spa. It’s usually after a few years that the problems emerge, she says. “Look at fen-phen.”
Fill ’Er Up
So you want Radiance, Artefill, Restylane. Before you tend to those wrinkles, you might want to know the facts first.
Injectable fillers that erase wrinkles are suddenly the bread and butter of every cosmetic dermatologist’s practice, and it seems a new one is being introduced every week. But are they safe? Here’s a crib sheet to the most popular—and controversial—cosmetic substances currently being pumped into New Yorkers.
What it is: A carbon-based polymer, derived from glass.
How it’s used: It’s injected in micro-droplets into fine lines, acne scars, and skin depressions, and used to enhance lips. In breast reconstruction, a new generation of silicone implants is being used on a limited basis.
Where it’s used: Popular in South America; less widely used in Europe; less widely used still in America.
FDA status: Silicone has been approved only for correcting detached retinas, not for any cosmetic purpose; it’s being used off-label as a filler while undergoing clinical trials. ln the late eighties, silicone was the breast implant of choice for many women and doctors, but because of thousands of lawsuits charging that the implants leaked and caused autoimmune diseases, it was taken off the market. The new implants are in FDA clinical trials and can be used only by doctors participating in the trials.
Pros: Results are permanent.
Cons: Results are permanent. Injected silicone can migrate to unwanted places or produce persistent nodules or bumps under the skin and are difficult to remove.
What it is: Tiny beads of polymethyl methacrylate (PMMA), an acrylic substance, suspended in a bovine-collagen solution.
How it’s used: As a wrinkle-filler and lip-enhancer.
Where it’s used: Started in Germany, now widespread in Europe.
FDA status: Recommended for approval by an advisory panel to the agency. Drug is now under consideration by the FDA.
Pros: The bovine collagen provides immediate benefits to the skin. Meanwhile, the PMMA beads are said to permanently boost your skin’s natural collagen production.
Cons: Granulomas, or hardened scar tissue, can appear six months to two years after injection; requires allergy testing since it’s derived from nonhuman collagen. No one knows what effect the beads will ultimately have on the body.
What it is: Microscopic calcium particles (hydroxylapatite) found in bone and teeth, suspended in gel.
How it’s used: As a wrinkle-filler and lip-enhancer.
Where it’s used: In the United States.
FDA status: Not approved for cosmetic use, but approved by the agency for such uses as treating incontinence (by beefing up bladder walls).
Pros: Long-lasting results (from two to five years).
Cons: Patients have reported developing bonelike deposits in places where Radiance was injected. Because it’s a calcium derivative, it can obstruct certain facial and dental X-rays.
What it is: Hyaluronic acid (a natural sugar present in the skin).
How it’s used: As a wrinkle-filler and lip-enhancer.
Where it’s used: In France and Canada.
FDA status: Hyaluronic acid was approved for use in ophthalmologic and orthopedic surgery ten years ago, but it is not yet approved for cosmetic use.
Pros: Lasts six months to a year (twice as long as collagen fillers).
Cons: Slightly more painful than other fillers; associated with more bruising and swelling at time of injection (especially lip injections).
What it is: Human collagen purified from human fibroblast cells grown in a lab; it’s a new, improved collagen.
How it’s used: Wrinkle-filler and lip-enhancer.
Where it’s used: In Europe, South America, and the United States.
FDA status: Approved for cosmetic use.
Pros: Allows for single-visit, same-day treatment.
Cons: Like collagen, it dissipates quickly, sometimes in as little as three months.