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

Patients Flock to Fat-Freezing Procedure, Sans FDA Approval

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.

VIDEO: A new procedure could potentially get rid of body fat.
Freeze Away Your Fat

"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.

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