When CoolSculpting® Goes Awry

Requests for Non-Surgical Fat Reduction have surged, Zeltiq announced on its corporate website; approximately 1.5 million CoolSculpting® procedures have been completed globally. While CoolSculpting® has been approved for the abdomen, flank and thighs and has been shown in studies to be comparatively safe and efficient, there are side effects, as well as potential complications.

Dr. Oleh Slupchynskyj, Director and Founder of The Aesthetic Institute of New York & New Jersey, indicates that his practice often uses CoolSculpting® on male and female patients.

Dr. Slupchynskyj acknowledges, “We have new patients requesting the treatment quite frequently.”

Redness, swelling, bruising and temporary tingling or numbness are normal side effects, according to Dr. Slupchynskyj. He 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.

Myla Bennett, MD, a Plastic Surgeon and Owner of the Ederra Bella Plastic Surgery and Medical Spa, in Johns Creek, Ga., says she has completed hundreds of CoolSculpting® procedures. Amongst those, two of her CoolSculpting® patients endured Paradoxical Adipose Hyperplasia after treatment.

“That’s where the patient will actually have a reverse reaction. Instead of fat reduction, they actually develop more fat cells in the treatment area. It occurs more often in men than women, and there’s really nothing you can do to prevent it or even know if somebody is at risk,” Dr. Bennett says.

Dr. Bennett says she is unaware of the complication steaming from other types of fat removal or reduction approaches, such as SculpSure. SculpSure and CoolSculpting® have an analogous goal: to attack and damage fat cells so they eventually die and are flushed out through the body’s lymphatic system. The difference is that while SculpSure uses controlled heat to eliminate fat cells, CoolSculpting® uses controlled cooling, also referred to as Cryolipolysis.

Researchers referenced the side effect in March, 2014 in JAMA Dermatology, reference the case of a man in his 40s who had one cycle of Cryolipolysis administered to his abdomen and developed a large subcutaneous mass several months following treatment.

“Paradoxical Adipose Hyperplasia is an extremely rare, previously unreported adverse effect of Cryolipolysis with an incidence of 0.0051 percent. No single coalescing risk factor has been identified. The phenomenon appears to be more common in male patients undergoing Cryolipolysis. Presently, there is no evidence of spontaneous resolution,” as indicated by the study’s abstract.

Minimizing Risk

Dr. Slupchynskyj advises doctors performing CoolSculpting® procedures use the supplied gel pad to reduce skin burn risk. They should confirm that it is smooth, without air pockets underneath. It’s also important to confirm that the gel pad is present at all edges around the applicator, he says.

To avoid step-off changes in contour, Dr. Slupchynskyj advises positioning the applicator in an area with naturally tapered edges or using overlapping applications to accomplish coverage of a larger area until you reach a more naturally tapered contour.

“Severe pain is  not common and usually resolves over weeks. A short-term prescription for pain medication can be helpful to provide relief,” Dr. Slupchynskyj says. “The genesis of Paradoxical Adipose Hyperplasia is not well understood; however it can be treated with traditional Liposuction or patients can opt for other forms of fat reduction therapy.”

Dr. Bennett states that one of the patients in her practice who had Paradoxical Adipose Hyperplasia declined further treatment. The other, a male, selected Liposuction to correct the area in his lower abdomen.

“I did notice, in treating him, that the fat was very fibrous. Treatment options I would suggest if someone encounters a patient who develops Paradoxical Adipose Hyperplasia is Laser Liposuction or Ultrasound-assisted Liposuction — something that will help separate the fat, before removing it,” Dr. Bennett observes. “Even in the articles I read, they identified more septal thickening around the fat lobules.”

CoolSculpting® Patient Selection Guidelines

Choosing the most suitable patients for CoolSculpting®, managing expectations and educating patients about what to expect before CoolSculpting® treatment, as well as potential side effects and complications, are compulsory measures for patient satisfaction, according to Dr. Bennett.

“It’s not a procedure for weight loss. It’s not a procedure for people who are extremely overweight in various areas. It’s for localized fat pockets that need to be reduced,” Dr. Bennett indicates.

CoolSculpting® works, Dr. Bennett says, but sometimes results are hard to observe because they’re gradual and happen during the months after treatment.

“After you treat patients, it’s three to four months before they achieve 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 crucial 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.”

As 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 talk to patients about potential warning signs, so that they can notify you if there are any concerns,” Dr. Slupchynskyj says. “If you run into a new complication that others have not written or spoken about, it’s valuable to notify associates and the manufacturer to discuss it further.”

Colleagues may offer a unique perspective. Feedback also enables manufacturers to monitor problems closely, gather data and drastically improve devices or devise plans for troubleshooting complications, as stated by Dr. Slupchynskyj.