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.”

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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.”