Patients Flock to Fat-Freezing Procedure Cryolipolysis, Sans FDA Approval

May 26, 2010— -- Lisa Pitonyak got tired of seeing and feeling her body's one flaw. No matter how much she worked out, she couldn't get rid of that stubborn belly fat.

"I'm 25 years old, and I've always had a 'pooch' in my lower abdomen," said Pitonyak, a nurse.

"I'm a woman, so feeling that pooch isn't a good feeling at all," she said.

She heard about a procedure called cryolipolysis -- a non-invasive method that involves freezing off fat cells -- and decided to find out more about it.

"I always just wondered what was out there," she said. She finally opted to give it a try. She paid $1,500 for her procedure.

In January, Dr. Arielle Kauvar, director of the New York Skin & Laser Center, performed Pitonyak's cryolipolysis.

Doctors who have used it say the procedure shows promise, and the freezing device used in the procedure has been approved by the U.S. Food and Drug Administration to anesthetize and cool the skin, but the FDA has not yet approved its use as a fat remover.

Still, that hasn't stopped physicians like Kauvar from using it off-label, a practice that is entirely legal. If it's in a doctor's best judgment to use a device or a drug for a reason other than what's indicated on its label, that violates no regulations.

Pitonyak spent two hours under the freezing device, getting the fat frozen out of two sections of her belly. Aside from some initial discomfort, she said, the procedure was painless. Afterward, she walked out of the office and went about her daily routine. She experienced some tingling, but that went away after about a week.

It wasn't just the tingling that went away -- so did that nagging pooch.

"It was very gradual," Pitonyak said. "I noticed it about two months later. When I sat down with jeans on, my pooch didn't bother me as much."

Kauvar is one of only a handful of doctors performing cryolipolysis. She and the other doctors in her office have been offering it since September. Kauvar decided to provide it to her patients after reviewing clinical trials.

Patients Flock to Off-Label Procedure Cryolipolysis

"I thought the clinical trials and the basic science were impressive," she said.

So far, Pitonyak and about 60 other patients have had cryolipolysis in Kauvar's office.

"Everyone who has had this procedure has been happy, which is unusual for a device-based aesthetic procedure," she said.

Pitonyak's fat loss after having the procedure is consistent with what studies have shown. Dr. Mathew Avram, director of the Massachusetts General Hospital Dermatology Laser and Cosmetic Center in Boston, said that so far, studies indicate that cryolipolysis can be effective for non-invasive fat removal.

"In one study, it showed a 22 percent fat layer reduction," he said.

Because there's no surgery involved and because of its potential as a fat buster, he and other doctors in the cosmetic medicine field say it's part of a growing trend.

"The trends are toward procedures that provide immediate benefits, but don't interfere with a person's busy schedule," said Avram.

"People continue to try and find alternatives to surgical removal of fat that are non-invasive and inexpensive," said Dr. Phil Haeck, a Seattle-based plastic surgeon and president-elect of the American Society of Plastic Surgeons.

Some doctors said the off-label nature of the procedure is not a major concern.

"FDA regulations are such that you have to prove safety and efficacy, but the claim doesn't have to be very far-reaching," said Dr. Mark Berman, president of the American Academy of Cosmetic Surgery.

Berman himself is known for his off-label use of products. In 1983, he was the first doctor in the world to use Gore-Tex, the breathable fabric, in cosmetic surgery. He used it to build up the bridge of a patient's nose. At that time, Gore-Tex was only FDA-approved for vascular surgery.

"If it was safe to use in the heart, then surely it was safe to use on the face," Berman said.

He also mentioned other procedures very commonly used off-label, such as Botox injections.

"Botox is a multi-billion dollar product," Berman said, adding that Botox injections were only FDA-approved to get rid of a particular type of wrinkle known as glabellar lines. However, doctors often use it off-label for other kinds of wrinkles as well.

Not All Approve of Off-Label Use of Cryolipolysis

Berman also said he believes that off-label use of drugs and devices for cosmetic purposes is on the rise, and the trend will continue.

"Medicine is in such bad financial straits, so lots and lots of doctors are looking for ways to make money," Berman said.

"People will be inundated by doctors who say they have all these machines. People will pay for these procedures, too," he said.

While many people may jump at cosmetic procedures like cryolipolysis aren't approved by the FDA, that doesn't mean these procedures are dangerous.

"Doctors are really scared of getting into trouble, so I don't think patients are in any danger from these off-label procedures," said Berman.

"The biggest danger is getting nothing; the devices are pretty harmless and don't do much."

But the American Society of Plastic Surgeons strongly disagrees.

"The association does not condone the use of non-FDA approved devices," Haeck said. He happens to be the group's president-elect.

That viewpoint doesn't faze people like Lisa Pitonyak, though. She knows that cryolipolysis isn't FDA-approved, but didn't let that stop her from having the procedure.

"Dr. Kauvar has a great reputation, and if she approves of it, then I have no problem with it," she said.