CoolSculpting® Mishaps

CoolSculpting Mishaps

Demand for Non-Surgical Fat Reduction is steadily increasing, as stated in Zeltiq’s claims on its corporate website; nearly 1.5 million CoolSculpting® treatments have been administered worldwide. Although CoolSculpting® is approved for the abdomen, flank and thighs, has been shown in studies to be relatively safe and effective, there are side effects and possible complications.

Dr. Oleh Slupchynskyj, Director and Founder of Chatham MediSpa, remarks that his practice regularly uses CoolSculpting® on male and female patients.

“We have new patients coming in to request the treatment every week,” Dr. Slupchynskyj says.

Redness, swelling, bruising and temporary tingling or numbness are common, typical 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 performed hundreds of CoolSculpting® procedures. Among those, two of her CoolSculpting® patients experienced Paradoxical Adipose Hyperplasia after treatment.

“That’s where the patient will actually experience a reverse reaction. Instead of fat reduction, they actually wind up with 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 not aware of the complication steaming from other types of fat removal or reduction approaches, such as SculpSure. SculpSure and CoolSculpting® have a comparable, fundamental goal: to target and injure fat cells so they eventually die and are flushed out through your body’s lymphatic system. The difference is that while SculpSure uses controlled heat to eliminate fat cells, CoolSculpting® uses controlled cooling, also known as Cryolipolysis.

Researchers reported the side effect in March, 2014 in JAMA Dermatology, cite 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 after treatment.

“Paradoxical Adipose Hyperplasia is a rare, previously unreported adverse effect of Cryolipolysis with an incidence of 0.0051 percent. 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,” as reported by the study’s abstract.

How to Decrease Risk

Dr. Slupchynskyj recommends doctors performing CoolScupting® procedures use the supplied gel pad to reduce skin burn risk. They should ensure that it is smooth, without air pockets underneath. It’s also a good idea to make sure that the gel pad is present at all edges around the applicator, he says.

To avoid step-off changes in contour, Dr. Slupchynskyj suggests 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.

“Severe pain is uncommon and typically resolves over weeks. A short-term prescription for pain medication can be helpful to offer relief in such cases,” Dr. Slupchynskyj notes. “The origin of Paradoxical Adipose Hyperplasia is not well understood; however it can be treated with traditional Liposuction or patients can consider other forms of fat reduction therapy.”

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

“I did observe, in treating him, that the fat was very fibrous. Treatment options I would advocate 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, before aspirating it,” Dr. Bennett comments. “Even in the articles I read, they identified more septal thickening around the fat lobules, and that makes sense.”

CoolSculpting® Patient Selection Protocol

Selecting the most suitable candidates for CoolSculpting®, managing expectations and educating patients about what to expect prior to CoolSculpting® treatment, 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 numerous areas. It’s for localized fat pockets that need to be reduced,” Dr. Bennett indicates.

CoolSculpting® does work, Dr. Bennett says, but sometimes results are difficult to perceive because they’re subtle and occur during the months following the procedure.

“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.”

With any technology, it’s important that doctors ask device manufacturers about possible 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 tell 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 colleagues and the manufacturer to discuss it further.”

Associates might have advice on how to proceed. The feedback also helps manufacturers better monitor problems, collect data and fundamentally improve devices or develop plans for troubleshooting complications, according to Dr. Slupchynskyj.