Zeroing In on Cellulite
By CATHERINE SAINT LOUIS
May 2, 2012
Selina, 53, did not want to worry about her lumpy thighs before her wedding in June. So when she heard a host on “The Doctors,” a syndicated TV show, say that a new treatment called Cellulaze can “banish cellulite,” she paid $6,500 for it. “The fact that it’s supposed to be a permanent solution was definitely what sold me,” said Selina, who got a hefty discount because she agreed to be Exhibit A for a doctor-training session.
In March, Selina grimaced as Dr. Barry DiBernardo, a plastic surgeon in Montclair, N.J., injected anesthetic liquid into her thighs, which had been marked with a tick-tack-toe grid: dimples colored red and bulging fat green. After making a few tiny incisions, Dr. DiBernardo passed a side-firing laser with a red-lighted tip under her skin in various directions as five other doctors watched. It made a muffled pop-pop-pop sound, not unlike a rattlesnake, as Selina’s fat cells broke. Periodically, as the laser scorched a connective fiber anchoring skin into a dimple, Dr. DiBernardo, a clinical investigator, would exclaim, “Oh, there, that was good, that got a good release.”
Trying to banish cellulite has long been one of women’s Sisyphean struggles. Previous remedies, like caffeinated creams or massage with laser therapy (sometimes costing thousands of dollars), could make bumpy skin look smooth. But the fixes were always temporary because they did little to tackle the structure of cellulite. And liposuction works on deeper fat levels, not just under skin where cellulite exists.
Now Cellulaze, which requires only one doctor’s visit, is being breathlessly hailed by many as a bona fide solution. Cleared by the Food and Drug Administration in January for showing improvement after three months, Cellulaze says that its laser technology attacks all three problems responsible for cellulite: bulging fat, too-thin skin, and the connective tissue that tugs at skin and creates dimples.
More than 100 doctors now offer — or are training to offer — the treatment, which has drawn attention from TV news shows nationwide. One morning show in Tampa even interviewed a doctor in scrubs as he treated a woman’s thighs. It’s been featured in Harper’s Bazaar, Self and Marie Claire. On NBC’s “Today” show, Dr. Bruce Katz, a Manhattan dermatologist and a clinical investigator, said, “We think if the cellulite hasn’t come back in two years, it’s probably going to be pretty much permanent.”
Many physicians are promoting Cellulaze as a long-lasting fix, with some even claiming that the results are permanent, even though the only published study, in Aesthetic Surgery Journal in 2011, had just 10 subjects, who had improvement a year after treatment. Such claims are powerful marketing tools for the doctors, who charge $2,500 to $5,000 for both buttocks or outer thighs, and thousands more for added areas. (Cynosure even suggests charging up to $7,000 for the first area the size of an 8-by-11-inch piece of paper.)
But the F.D.A. clearance stipulates that Cynosure, the maker of Cellulaze, “can only make statements based on our decision on the three-month data,” according to Erica Jefferson, an F.D.A. spokeswoman, who added, “The indication should be for ‘short-term improvement.’ ” The F.D.A. does not police the claims of doctors who use the treatment.
Cellulaze hasn’t yet earned credibility for its claims in peer-reviewed journals, though it said multiple studies, some with follow-up as far as three years, are being prepared for submission. The Aesthetic Surgery Journal study was unblinded, meaning it was performed and evaluated by Dr. DiBernardo. He is one of five paid clinical investigators and a training consultant for Cynosure who has taught 70 doctors.
“All of the important pieces of information from the study were objective,” he said, adding that ultrasounds showed that skin got thicker, and also that a skin-elasticity-measuring device indicated that loose skin got tighter.
“At the end of the day, we cannot go on a small study that was unblinded,” said Dr. Molly Wanner, an instructor in dermatology at Harvard Medical School and an author of an evidence-based review of cellulite treatments in 2008. At a recent conference, Dr. DiBernardo presented six-month blinded data that “provides more evidence Cellulaze may be a viable treatment,” she said.
Dr. Z. Paul Lorenc, a plastic surgeon with 15 years of laser experience, is not convinced that the connective fibers destroyed by Cellulaze won’t grow back together, creating hills and valleys once more. “The jury is still out,” he said.
The side effects noted in the 10-person study also gave Dr. Wanner pause. “It is fairly significant to have three months of prolonged discomfort, bruising, swelling and numbness,” depending on severity, she said.
But none of this bothered Linda Kiesel-Zabludovsky, 57, an owner of a wholesale bakery who lives in Springfield, N.J., and who had her outer thighs treated in March 2009 at no cost, as part of Dr. DiBernardo’s research. Ms. Kiesel-Zabludovsky said she had “a lot of bruising,” but felt so good days after that she flew to the British Virgin Islands for vacation, even though she had to wear medical-grade compression garments on the beach. “I was gleeful I’d done it,” she said, explaining that the treated area “is really smooth.”
“It’s fabulous,” she added.
And now, three years later? “It’s as smooth as it was after the procedure,” she said.
By contrast, Wanda Lamberty, 41, said, “If I had to do it again, I wouldn’t get it done.” In July 2010, she had her thighs treated free, as part of another study, where the laser energy used was more than doubled. Within a week, her left leg was retaining a lot of fluid, a complication called a seroma. It had to be drained every two weeks for months. Dr. DiBernardo “would put a syringe in my left leg and take out fluid that was building up,” said Mrs. Lamberty, who works at a Department of Motor Vehicles near Helmetta, N.J. “That was time I had to take off work.”
Four months after her Cellulaze treatments, Mrs. Lamberty said, indentations appeared on her leg that looked as if holes had been carved out by a potato peeler. Nearly 18 months later, the indentations remain, and the skin “looks like it’s bruised still,” she said, adding, “You live with the consequences.”
Dr. DiBernardo, who put this reporter in touch with Mrs. Lamberty, now recommends that patients with severe cellulite and loose skin like her shouldn’t be treated with Cellulaze alone, if at all. Doctors who use it are taught to draw squares on a patient’s leg with Sharpie markers, which helps them avoid applying too much laser energy to any area. (During the procedure, Selina said the pain could reach eight, on a scale of zero to 10.)
“Do too much, you’ll get a seroma,” Dr. DiBernardo said. (The F.D.A. data had none, he added.)
A doctor’s skill matters. “This isn’t just running light over intact skin,” Dr. DiBernardo said.. A physician — ideally a plastic surgeon with liposuction experience, he said — needs to have “a tactical sensing of what’s happening and whether you need to do more.”
Karen Cronholm, a senior product manager for Cynosure, said the company sold Cellulaze mainly to plastic surgeons. “And if they are not plastic surgeons, they have to meet certain requirements,” she said.
But doctors board-certified in ob/gyn, internal medicine, family medicine, and ophthalmology also offer the treatment, according to Cellulaze’s Web site. According to Cynosure, these providers receive training and their experience doing procedures like liposuction is vetted.
“Nothing replaces experience as far as the predictability of results,” said Dr. Lorenc, who advises patients to ask doctors how many subcutaneous laser procedures they have done in general, and about their experience with Cellulaze. (Board-certification can be checked online.)
Michael Davin, the chief executive of Cynosure, turned down an interview request, but in an e-mailed statement, the company said, “We believe that Cellulaze will be a commercial success, a direct result of our focus on — and investment in — physician training and patient safety.”
Certainly, if patients are pleased, the treatment could prove a cash cow for the company. Carol, 42, experienced sticker shock after consultations with two Chicago-area doctors. One said it would cost $9,500 to treat the front of her thighs, outer thighs and rear end; another, Dr. Kenneth L. Stein, a board-certified plastic surgeon, said he would charge $11,300.
In March, she asked Dr. Stein how many patients of his had undergone the procedure.
He replied, “Two.” (He said he has now treated six.) Carol later said, aghast, “I’m going to be shelling out $11,300, and I’ll be the third one?”
Last month, she flew to Dr. DiBernardo in New Jersey, because he had “a lot of experience.” (He has had a couple hundred patients, and charged her $7,500 after a $1,000 discount for being part of a doctor-training session.)
But cellulite bothers some women so much that they might not take the time to comparison-shop.
“These doctors know women will pay for it,” said Carol, who is still swollen from Cellulaze but hopeful she might one day wear a bathing suit. “Women are embarrassed about it.”