FDA Approves Zeltiq and Zerona Fat-Removing Procedures
Two new body-contouring treatments have received US Food and Drug Administration (FDA) approval. Zeltiq, a fat-freezing technique, and Zerona, a laser treatment, are lower-cost, non-surgical treatments for localized fat loss.
Fat-removing Procedures Are Not A Gimmick, Says the FDA
"This is a big deal," plastic surgeon Lawrence Bass told ABC’s Good Morning America. "It's the first time the FDA has cleared a non-invasive fat-reduction technology."
Zeltiq, trademarked as CoolSculpting™ and also called Cryolipolysis™, uses a gel patch attached to a machine that freezes fat cells, causing the cells to crystallize and die. They then become reabsorbed by the body over several months. The device, originally created to anesthetize and cool the skin before dermatology procedures, has been used off-label for about a year and results have been good. Evidence shows that it is effective in reducing fat deposits by an average of 22%.
According to company founder Mitchell Levinson, about 7,000 patients have had the Coolsculpting Procedure to date. Zeltiq takes about one to three hours per troubled area and results can be seen in about in three to four months. Each treatment costs between $1500 and $3000.
Zerona, a procedure trademarked by Erchonia Healthcare and the first treatment of its kind to receive FDA approval, works by aiming a low-energy laser at fat pockets causing the fat cells to collapse or deflate. Because the cells become smaller, a person loses inches.
In clinical trials, patients undergoing the Zerona procedure lost an average of 3.65 inches from their waist, hips and thighs (about an inch per area) compared to only a half-inch experienced by the placebo group.
Patients lie on a table while the laser device rotates around the abdomen and hip area. The Zerona procedure takes about 40 minutes per session and is repeated three times a week for two weeks. Results can be seen after about 4 to 6 sessions, at a total cost of $1800 to $3000.
Dr. Bass warns consumers not to assume that either of these treatments will replace diet and exercise for weight loss. It is also not intended for the obese patient who needs to lose a large amount of weight. “They are another option for a subset of patients that just need to take a little bit off,” he says. The procedures will also not prevent future weight gain.
The American Society of Plastic Surgeons says that last year, nearly 200,000 people underwent a plastic surgery procedure to remove unwanted fat.