What Is Cool Sculpting?
Cool Sculpting is the brand name for a non-surgical method for the reduction of fat tissue, cryolipolysis which works by freezing fat cells. It is used as an alternative to other fat removal methods such as liposuction. It was developed by Zeltiq and is reported to reduce unwanted fat by up to 25 percent
Cool Sculpting was developed at Harvard University and was approved by the U.S. Food and Drug Administration in 2010. Use of Cool Sculpting has been linked to a side effect known as Paradoxical Adipose Hyperplasia (PAH) which may cause new growth of bulges, bumps, and hard knots in the treatment area.
How Does Cool Sculpting Work?
Cool Sculpting uses a process called cryolipolysis which was developed at Harvard when researchers were studying the results of frostbite on different tissues of the body. Scientists noted that fat cells freeze at higher temperatures than other tissues and may be damaged sooner during frostbite.
Cool Sculpting uses a device that operates as a handheld suction device to lift skin and fat tissue intended to be treated between two paddles. The device delivers targeted low temperatures to these areas of fat deposits. Because fat freezes at a higher temperature than other cells, it is designed to only freeze fat cells in the treatment area but to leave surrounding cells, including the skin, undisturbed. The temperature application beneath the skin freezes fat cells which then die, leaving cell contents to be removed as waste products by the body.
Allergan/AbbVie, manufacturer of Cool Sculpting states that people receiving the treatment will see a fat reduction in the area of 20-25% from just one treatment. Results begin to appear over a 3-week period and maximize at about 2 months.
What Are the Reported Side Effects of Cool Sculpting?
Cool Sculpting’s manufacturer and marketing information advises that most people experience minimal discomfort. Side effects may also include numbness, pinching sensations, and tugging during the procedure. After the procedure, people may experience bruising, temporary numbness, swelling, redness, tingling or stinging and mild pain.
Some people who received Cool Sculpting have reported more severe side effects which begin weeks or months after treatment and result in growth of bumps, bulges, and hard knots or rectangular shapes under the skin. This may be caused by Paradoxical Adipose Hyperplasia (PAH).
What Is Paradoxical Adipose Hyperplasia?
Paradoxical Adipose Hyperplasia (PAH) or Paradoxical Hyperplasia (PH) is an unusual or unexpected growth of fat tissue. As a side effect of Cool Sculpting, it occurs in the area which was treated for fat reduction. PAH results in new growth of fat tissue that may cause bulges, bumps, or hard knots beneath the skin.
In some cases, the shape of the new growths mimics the shape of the device which was used in the Cool Sculpting treatment. Some people who develop PAH have described the growths as “sticks of butter” as they are square and raised, giving the appearance of a block of fat under the skin.
How Has Cool Sculpting Been Promoted?
Cool Sculpting has made its appearance in popular culture and television. It was featured on the “Dr Oz” show, and shown on the reality show, “Keeping Up with the Kardashians”. It has also been featured on Gwyneth Paltrow’s wellness website, blogs, and podcasts.
Notable recipients include former Super Model Linda Evangelista who received the Cool Sculpting procedure but developed PAH and sued the company. She recently disclosed the results of her lawsuit against Cool Sculpting in a People Magazine article, stating that a settlement agreement had been made.
What Are the Alternatives to Cool Sculpting?
Cool Sculpting is intended and marketed to be an alternative to surgical treatment methods of fat removal such as liposuction. It is also promoted as an alternative to other non-surgical fat reduction methods which use heat or cold temperatures to dissolve fat.
Cool Sculpting is advertised to be cheaper and safer than alternatives such as liposuction, but the cost may still be in the thousands of dollars.
What Treatments May Be Required for PAH?
When PAH develops as a result of Cool Sculpting treatment, the new fat growth is considered permanent and may be hard to ignore. It will often require removal of the new fat tissue through surgical methods such as liposuction. This may require more than one treatment and may still leave undesirable lumps or growths.
Though Cool Sculpting itself may be less expensive and require significantly less recovery time, the treatment to repair damage may be much more costly than any savings that resulted from choosing the procedure over liposuction.
Is There a Cool Sculpting PAH Lawsuit?
After Ms. Evangelista’s settlement announcement and other reports of PAH’s link to Cool Sculpting, more victims may be considering lawsuits against Allergan and AbbVie.
People who developed new bumps, bulges, or growths or were diagnosed with Paradoxical Adipose Hyperplasia (PAH) or Paradoxical Hyperplasia (PH) or in the treatment area after Cool Sculpting fat-removal treatment may be eligible for compensation.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.