Coolsculpting Side Effects Cause Disfiguring PAH Complications For Some Users: Report

Doctors say they see much higher rates of CoolSculpting side effects, such as abnormal bulges, than indicated on the device’s warning label.

A recent investigative report warns about potentially hidden risks and complications with CoolSculpting, a nonsurgical way of freezing away unwanted fat, which has been linked to reports of deformations, bulges and other side effects.

CoolSculpting has been marketed as a safe and effective treatment for the removal of fat from areas of the body, without having to undergo surgery. The procedure involves a device that uses cryolipolysis to target and freeze of fat cells.

It was approved by the FDA in 2010, and has since spread in popularity nationwide. However, a number of doctors are raising warning flags about the potential Coolsculpting side effects, indicating it has been linked to a high rate of severe disfigurement, where the fat grows, instead of shrinks, leaving patients deformed and often requiring them to undergo numerous surgeries to correct the problems, according to an investigative report by The New York Times published on April 16.

CoolSculpting PAH Side Effects Underestimated

The Coolscuplting complications involve a condition known as paradoxical adipose hyperplasia (PAH), which Allergan Aesthetics, which owns CoolSculpting, says only happens in about 1 out of 3,000 treatments. Allergan acquired ownership of CoolSculpting from Zeltiq, the original manufacturer, who originally calculated PAH was only a risk to 1 in 20,000 treatments.

Concerns about the side effect began to gain widespread attention after former supermodel Linda Evangelista went public about the problem in 2021, having developed PAH from a CoolSculpting procedure.

A number of studies were conducted by the manufacturers, indicating the Coolsculpting PAH side effect rates were extremely low. However, the new report by The New York Times indicates that a growing number of doctors are stepping forward to say their practices have seen large percentages of patients who have suffered PAH, with rates of the Coolsculpting problem much higher than the manufacturer has suggested.

The issue, they say, is that the original research by the manufacturer calculated the rate of PAH based on incidents per procedure. That number has been interpreted, and critics say marketed, as the manufacturers’ published Coolsculpting risk rate for patients.

There is a problem with that, doctors claim. Patients usually undergo numerous CoolSculpting procedures, sometimes as much as two dozen over the same location.

Doctors warn that means the actual risk to patients is much higher than 1-in-3,000, since that number assumes a patient only gets one treatment. For example, if a patient gets two treatments, which is often the bare minimum, their risk of PAH may be twice as high. The more procedures they undergo, the higher the risk of Coolsculpting PAH appears to be.

In 2016, one plastic surgeon, Dr. Jose Rodriguez-Feliz, published a letter in the medical journal Plastic and Reconstructive Surgery, indicating that his practice saw a Coolsculpting PAH side effect rate of one out of every 128 patients. Another group of doctors estimated the PAH rate for CoolSculpting was 1 in 100 patients in 2017.

In 2020, Canadian researchers published a study in Aesthetic Surgery Journal which warned of much higher rates. However, those rates have decreased with the use of newer CoolSculpting devices, the researchers found.

CoolSculpting Injury Reports

Another reason for concern about the CoolSculpting procedure is that, according to the New York Times, many of the incidents go unreported for a number of reasons.

One reason is because the condition is hard to detect. Patients who experience abnormal growths and bulges as a result of PAH often think they just regained the weight they lost, and blame themselves. Often the effects are very subtle and can take months to become visible.

However, another problem is that the original manufacturer, Zeltiq, determined in 2013 that it did not need to report the incidents to the FDA, according to the report. Zeltiq claimed an FDA auditor informed them that PAH did not qualify as a life-threatening or serious injury and stopped reporting the incidents.

The FDA disputes this, saying that the auditor may have been mistaken and advice from an FDA auditor which is faulty does not negate a company’s reporting requirements under the law. Because PAH can result in deformities which can require reconstructive surgery, those incidents should be reported, the agency said. Allergan, the current owner of CoolSculpting, indicates it adheres to FDA reporting requirements.