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

"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.

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