Recent CoolSculpting Media Coverage: Observations and Clarifications

As an aesthetic key opinion leader, and longtime member of the Editorial Board of Modern Aesthetics® magazine, I would like to add observations and clarifications regarding some of the recent attention to CoolSculpting in the news.

CoolSculpting technology was developed by Harvard and MIT dermatologists, Rox Anderson, MD and Dieter Manstein, MD. It has been used as a non-invasive fat reduction treatment with great success since the clinical trials in the mid- to late-2000s. More than 11 million treatments have been performed to date. Recently, the story of model Linda Evangelista having a complication she attributes to a CoolSculpting procedure she received several years ago hit the news. She says she experienced a known complication of treatment called Paradoxical Adipose Hyperplasia (PAH), where focally, instead of the underlying fat being reduced, it is actually increased. PAH is extremely rare, with most published reports citing an incidence between 0.05 to 0.39 percent of treatments. PAH was first described in 2014, and focal traditional liposuction has been successfully utilized to treat it in these rare circumstances, with support from the manufacturer.

I am certainly sympathetic to Miss Evangelista’s story. Whenever an undesired event takes place, it is indeed heartbreaking to the patient and also the physician, the facility, as well as the manufacturer. Recognizing the ongoing media and social activity, however, it is important that we as physicians drive fact-based understanding of what treatments can offer, including any associated risks, for our patients. This type of fat reduction treatment has proven to be safe and effective for patients since FDA clearance in 2010.

Rare risks are prevalent across our lives and are highlighted across the news, such as amusement park accidents or a ski resort mishaps. It is truly unfortunate that complications and adverse outcomes do occasionally occur, including from elective procedures, as well as from elective recreational activities. To be comprehensive regarding said rare risks, in medicine we use detailed consent forms to alert patients and customers about these potential issues. Sometimes the potential complications in these consent forms can occur—and in many cases, it actually isn’t because of any negligence, but simply bad luck. In the case of PAH, which again is extraordinarily rare, the exact etiology is still unknown; we cannot yet determine why a rare patient has this response but the overwhelming majority does not.

I don’t perform CoolSculpting in our offices (but we do use other Allergan aesthetic technology); however, I do believe that CoolSculpting treatment remains a very reasonable option for people who have focal areas of undesired fat deposition. Whether it is the “double-chin,” “belly-fat,” “muffin-top” on the flanks, or “saddlebags” on the thighs, CoolSculpting remains a viable option, typically providing very good results for people interested in seeing reduction of localized fat in these areas. The negative CoolSculpting press right now about PAH has certainly created heightened concern amongst patients, but nevertheless people still remain interested in treating localized areas of fat. It is important to note that the competing options to treat these same concerns, such as liposuction, have potential risks as well—including asymmetry and wavy and undulated skin. Liposuction may be done with tumescent anesthesia while the patient is awake (a procedure pioneered by dermatologist Jeffrey Klein, MD) with risks that include lidocaine toxicity as well as bleeding, infection, or for the abdomen, perforation of the diaphragm. Liposuction can and traditionally has been done under general anesthesia, with the same potential risks that include bleeding, infection or diaphragmatic perforation, along with the risks of a general anesthesia adverse reaction, which rarely can include death.

In short, while PAH associated with CoolSculpting has certainly been in the news recently, now more than ever, it is essential to illuminate the fact that in the overwhelming majority of cases, this treatment remains a safe, effective, and reasonable treatment for people who have focal fat areas that they want to improve. I certainly feel that it is worth the small risk, just as with other procedures that we perform on a daily basis to make people feel better about themselves and improve self-esteem.