Although medicine is a global community, specific protocols tend to be local. Most countries boast their own regulatory agencies that, in turn, impose their own guidelines regarding safety, efficacy, evidence and approval of medical devices, drugs and applications.

Dr. Sattler

Protocols currently making a splash across the pond include two noninvasive body-contouring techniques — cryolipolysis (CoolSculpting, Zeltiq Aesthetics), which uses cold, and UltraShape (UltraShape), which employs focused ultrasound technology.

"Cryolipolysis is based on the principle that fat cells are more vulnerable to energy extraction than surrounding tissues. Cooled fat cells undergo apoptosis and are gradually eliminated, reducing the thickness of the fat layer," says Gerhard Sattler, M.D., a founder of Rosenpark Clinic, Darmstadt, Germany.

Dr. Steinert

"Procedure time can take up to two hours or more depending on the size of the area to be treated," Dr. Sattler says. During the final phase, the fat cells are removed in a natural process that continues for several months and results in gradual fat-layer reduction.

"Clinical studies demonstrate the CoolSculpting procedure provides noticeable, measurable fat reduction in properly selected patients over the course of two to four months following the procedure. Additional procedures may be administered [then] to achieve greater fat reduction," Dr. Sattler says.

Long-term studies have not been completed, but available data presented as a poster at the 2009 annual meeting of the American Society for Dermatologic Surgery indicates patients show persistent results at least six months after the procedure. Results are expected to last as long as those from more invasive protocols (such as liposuction), although the actual effect is often less dramatic in comparison.

Ideal candidates are relatively fit and want to target stubborn, modest-sized fat bulges noninvasively.

"The CoolSculpting procedure is not intended for weight loss or obesity, and it is not a substitute for invasive methods, such as liposuction," Dr. Sattler says. It is currently most commonly used to treat "muffin tops," love handles and back fat, though other areas may also be addressed.

Contraindications for cryolipolysis treatment include two rare conditions — cryoglobulinemia and paroxysmal cold hemoglobinuria. Otherwise, risks are low, side effects rare and recovery immediate.

The Zeltiq CoolSculpting cryolipolysis device.

Before use, physicians need to be trained on the device, committing to specific patient selection criteria, case management responsibilities and protocol requirements. Zeltiq CoolSculpting has been cleared for use in the United States for applications related to skin cooling during dermatologic treatments, and it holds a pending application with the FDA for use in noninvasive fat-layer reduction.