Demand is high for nonsurgical fat reduction, as evidenced by Zeltiq’s claims on its corporate website that nearly 1.5 million CoolSculpting treatments have been performed worldwide. And while CoolSculpting, which is approved for the abdomen, flank and thighs, has been shown in studies to be relatively safe and effective, there are side effects and potential complications.
Kavitha K. Reddy, M.D., a dermatologist and director of the Cosmetic & Laser Center at Boston University Medical Center, Boston, Mass., says her practice regularly uses CoolSculpting on male and female patients.
“… we have new patients requesting the treatment each week,” Dr. Reddy says.
Redness, swelling, bruising and temporary tingling or numbness are common, normal side effects, according to Dr. Reddy. She says potential complications with cryolipolysis include skin damage, leading to ulceration or scarring; prolonged or severe pain; abrupt fat layer changes, including "step-off" changes; and paradoxical adipose hyperplasia.
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Myla Bennett, M.D., a plastic surgeon and owner of the Ederra Bella Plastic Surgery and Medical Spa, in Johns Creek, Ga., says she has performed hundreds of CoolSculpting cases. Among those, two of her CoolSculpting patients had post-treatment paradoxical adipose hyperplasia.
“That’s where the patient will actually get a reverse reaction. Instead of fat reduction, they actually end up with more fat cells in that area. It happens more commonly in men than women, and there’s really nothing you can do to prevent it or even know if somebody is at risk for it,” Dr. Bennett says.
Dr. Bennett says she is not aware of the complication arising from other types of fat removal or reduction approaches.
Researchers reported on the side effect in March 2014 in JAMA Dermatology, documenting a case of a man in his 40s who underwent a single cycle of cryolipolysis to his abdomen and developed a large subcutaneous mass in the months following treatment.
“Paradoxical adipose hyperplasia is a rare, previously unreported adverse effect of cryolipolysis with an incidence of 0.0051%. No single unifying risk factor has been identified. The phenomenon seems to be more common in male patients undergoing cryolipolysis. At this time, there is no evidence of spontaneous resolution,” according to the study’s abstract.
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NEXT: How to Reduce Risk
How to Reduce Risk
Dr. Reddy suggests doctors performing CoolSculpting procedures use the supplied gel pad to reduce skin burn risk. They should make sure it is smooth, without air pockets underneath. It’s also good to ensure that the gel pad is present at all edges around the applicator, she says.
To avoid step-off changes in contour, Dr. Reddy recommends placing the applicator in an area with naturally tapered edges or using overlapping applications to achieve coverage of a larger area until you reach a more naturally tapered contour.
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“Severe pain is uncommon and usually resolves over weeks. A short-term prescription for pain medication can be helpful to provide comfort in these cases,” Dr. Reddy says. “The etiology of paradoxical adipose hyperplasia is poorly understood, however it can be treated with traditional liposuction or one can consider other forms of fat reduction therapy.”
Dr. Bennett says one of the patients in her practice who had paradoxical adipose hyperplasia elected to do nothing. The other, a male, opted for liposuction to correct the area in his lower abdomen.
“I did note, in treating him, that the fat was very fibrous. What I would recommend if someone runs into a patient who develops paradoxical adipose hyperplasia is laser liposuction or ultrasound-assisted liposuction — something that will help emulsify the fat, prior to aspirating it,” Dr. Bennett says. “Even in the articles I read, they found that there is more septal thickening around the fat lobules, and that makes sense.”
NEXT: Steps for Patient Selection
Steps for Patient Selection
Selecting the best candidates for CoolSculpting, managing expectations and educating patients about what to expect, as well as potential side effects and complications, are necessary steps for patient satisfaction, according to Dr. Bennett.
“It’s not a procedure for weight loss. It’s not a procedure for people who are diffusely overweight in multiple areas. It’s for localized fat pockets that need to be reduced,” Dr. Bennett says.
CoolSculpting does work, Dr. Bennett says, but sometimes results are hard to detect because they’re subtle and happen during the months following the procedure.
“Once you treat patients, it’s three to four months before they get to their final results. And we take pictures all along the way. So, when we did have a patient who said, ‘I don’t think it’s working,’ we would pull out their before and after photos and they would [realize it was working,]” Dr. Bennett says. “It’s imperative to have photo documentation of where they started and where they ended up, and also keep track of their weight. We would have patients come in for photos and weigh-ins. If somebody was 20 pounds heavier three months later, you can’t blame the procedure.”
With any technology, it’s important that doctors ask device manufacturers about potential complications, read product manuals and speak with experts and colleagues who have used the devices about their experiences.
“It’s helpful to tell patients about potential warning signs, so that they can alert you if there are any concerns,” Dr. Reddy says. “If you encounter a new complication that others have not written or spoken about, it’s valuable to alert colleagues and the manufacturer to discuss it further.”
Others might have advice on how to proceed. The feedback also helps manufacturers better monitor problems, collect data and ultimately improve devices or develop plans for managing complications, according to Dr. Reddy.
Drs. Reddy and Bennett report no relevant disclosures.