This past July (2022), the manufacturer of CoolSculpting decided to voluntarily recall five of its CoolSculpting applicators (CoolMax, CoolCore, CoolFit, CoolCurve+, and the Cool Curve) because the devices were linked to an increased risk of developing a deforming condition called Paradoxical Adipose Hyperplasia. This “increased” risk was discovered as the result of the manufacturer finally starting to report cases of PAH to the FDA’s Medical Device Adverse Events Database in 2021. Prior to that, barely any PAH reports were made to the FDA.
Read more about the recall here.
The recall affects the entire US and many countries around the world. Accordingly, the manufacturer reported to the FDA, that CoolSculpting providers in possession of the affected devices should stop using them on patients immediately and return them.
But why has the manufacturer of CoolSculpting not announced this recall to the public? Don’t consumers have the right to know about this global recall? As I write this blog post (April 24, 2023) there is nothing mentioned on the CoolSculpting website about the worldwide recall. Why not?
I have been litigating CoolSculpting cases since 2019 when my first CoolSculpting client developed Paradoxical Adipose Hyperplasia (PAH) after undergoing the “non-invasive” fat-reducing procedure in 2018. That case is currently under appeal in the United States Court of Appeals for the Eleventh Circuit – the legal issues under appeal affect thousands of other people who have been similarly injured by the CoolSculpting device.
That case was the beginning of my long journey of representing many others who have been injured by the CoolSculpting device.
Over the years, I have found that the information consumers receive from the manufacturer’s advertisements and their CoolSculpting providers is not consistent with the personal accounts of those actually injured by the procedure. I have also found that plastic surgeons who fix CoolSculpting complications are reporting much higher incidence rates of PAH and difficulty in performing reconstructive surgery on CoolSculpting deformities. Many people who develop PAH need multiple surgeries to remove the disfiguring masses that develop at the treatment sites. People injured by CoolSculpting are left with physical and emotional scars from the invasive surgeries.
Recently the New York Times published an expose about CoolSculpting and PAH. The journalist interviewed a beautiful young woman named Gina, who I happen to know through our PAH Support Group. She told the story of being at a loss for many years, not knowing why she had fat-like masses growing in her abdomen after undergoing CoolSculpting. Her doctors did not know about PAH and told her to lose weight – an inappropriate recommendation for the condition. Instead, Gina says, she lost her family due to the great emotional suffering she endured while she looked for answers.
So now that a large majority of the original CoolSculpting device’s applicators have been recalled, do Allergan, Abbvie, Inc., or Zeltiq Aesthetics, Inc. (all entities associated with the manufacturing of the CoolSculpting devices) have at least a moral responsibility to tell consumers about this?
In my personal opinion, I think the manufacturer should have done everything it could to notify consumers about the global CoolSculpting recall, as early as July 2022. This could have helped someone else avoid Gina’s difficult journey.
As a Cosmetic Procedure Injury attorney, I understand people’s desire to look their best. I know how important it is, in our modern society, to look young and fit. So, when a new technology becomes available promising to solve an aesthetic problem, I recognize the public’s interest in trying it out. But, through my extensive work investigating various cosmetic products and devices, I am also well aware that the glamour of the manufacturers’ advertising can overshadow the reality of how dangerous these products can really be. Therefore, I think that the same companies that pour millions of dollars into marketing the benefits of their products should also spend some time and money on notifying consumers of their dangers.
If you have undergone CoolSculpting, you should discuss this recall with your CoolSculpting provider. You should also monitor closely any developing signs of Paradoxical Adipose Hyperplasia at each of the treatment sites where you had the procedure done.
