Patients Flock to Fat-Freezing Procedure Cryolipolysis, Sans FDA Approval
Cryolipolysis has research to back its use, but not yet the approval of the FDA.
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.
"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.