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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%.

Read: Rachael Ray Presents Secrets of Plastic Surgery

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.

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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.

Read: ISAPS Study Finds Liposuction Most Performed Plastic Surgery Procedure

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.



My procedure was done 5 days ago, so I really don't know what the final result will be. I'm making this post so that others will know what to expect. I had two one-hour treatments on the same day. First the right side of my tummy was done and then the left side. There was quite a bit of discomfort when the fat is sucked into the machine, but that discomfort goes away after about 10 minutes. I was surpised that the fat sucking cups are very small -- probably about 4" by 2" and about 3" deep. That's why I had to endue the procedure twice. Only so much fat could be placed into the machine. Please understand that I am certainly not obese -- I am a size 6. My stomach just has a pooch. To get the entire stomach area, the procedure had to be performed on each side of my belly button. When each hour ended, my skin felt frozen -- almost like hamburger meat, but that went away quickly. When I got home I noticed that bruising had already begun. The skin on my left side had been punctured so I had some bleeding. It is now 5 days later, and I'm in a lot of pain. The area is basiclly numb to the touch except for a shooting pain that begins in the same area where my bleeding occurred. I really feel ashamed of myself for spending $1,500 for this procedure. If I achieve the average result, then 20% of the fat that was sucked into those cups will disappear. I don't think that will be significant enough to even notice, but I hope that I'm wrong. Before you invest in this procedure, please ask your doctor to see the machine. I think that you'll be amazed at the very small area that will be treated.
Zerona not only works but it is approved and is safe. I recommend it to anyone. Tim Orlando Zerona Lasers
I underwent 6 Zerona sessions with very little result and certainly not detectable two weeks later. I maintain a healthy diet and exercise daily. I followed all the technicians directions. Also, just because the FDA has cleared these devices as safe for public use it does not mean that they have been shown to be effective. Given the cost I don't recommend them.