In September, the FDA approved Zeltiq's CoolSculpting device for the nonsurgical reduction of fat. The FDA had previously approved all components using the 510(k) equivalency method, but it was not until September that the device was actually approved for fat reduction. The FDA has not yet approved labeling for the device, so it's hard to know what exactly the device was approved for, but according to its manufacturer, the FDA approved claims that CoolSculpting can reduce fat by up to 20% in treated areas. Zeltiq also says that the treatment can be repeated successively, creating cumulative fat losses of up to 40% in treated fat deposits.
CoolSculpting works by cooling fat deposits down to a lethal temperature, which damages and eventually kills fat cells. Over time, the body removes the dead fat from the treated area, leading to a fat reduction in that area.
Of course, everybody would love to take a pill, get a shot, or do something equally quick and painless to have their areas of unwanted fat disappear, but unfortunately it doesn't work that way. Remember, for example, Lipodissolve, an injection that claimed to reduce fat, but earlier this year was slapped with a series of warnings by the FDA.
CoolSculpting has been approved, which means that the FDA believes the procedure shows a reasonable assurance of safe and effective, but the procedure shows a number of limitations that are worth noting:
- The areas of treatment are limited because the machine must be able to pull the fat deposit between its cooling panels.
- The full effects of fat death take several months to be visible, and it is not until then that you know whether you have to repeat the treatment.
- CoolSculpting does not stimulate skin retraction, so that people who use CoolSculpting often have excess loose skin.
- CoolSculpting is a mechanical process, working without the guidance of a plastic surgeon, so it is incapable of achieving the artistic contouring that many surgeons achieve with liposuction.
- The long-term effects of the device have not been studied.
CoolSculpting is another body contouring option, but is unlikely to be beneficial for many people. You are encouraged to look at before and after pictures for both procedures and talk to a board-certified plastic surgeon before making a decision about which procedure is best for you.
Dr. George Lefkovits is a board-certified plastic surgeon who has been helping his patients from New York and around the world achieve great-looking results for nearly three decades. He has seen many fad treatments come and go because they just don't give the promised results. To talk to him about proven techniques that give great results, please call or email us today.