I Read About CoolSculpting® in the News- Is It Safe?
If you are in the loop or have heard from us directly, you might already know that we had to take a break from using the newest body shaping device- CoolSculpting® Elite.
Quick background- We have been using CoolSculpting® technology for 11 years for non-invasive fat reduction. We acquired their newest device in May 2021 CoolSculpting® Elite which takes this treatment to another level! We can treat more body areas at once and have applicators better suited for a wider variety of adipose or fatty tissue, sometimes increasing the tissue contact to 17%.
I’ll share the good news first. For those of you who have been waiting to have or resume your treatment with CoolSculpting® Elite, I am ecstatic to tell you that we now have the green light to continue treatments- YAY! At the end of August 2021, the FDA required a review of the software update for the new Elite device, requiring all offices to stop using the device until approval. The update allows for accurate messaging and data when errors occur to make sure patients are safe during their CoolSculpting® treatments. In alignment with the FDA’s initiative to assure comprehensive data is available and proper education is provided, there has also been an update to the patient-facing materials given to those who are considering or currently undergoing a CoolSculpting® treatment. The rare side effects that can happen after a CoolSculpting® treatment have not changed and are listed later in the article. With more treatments happening worldwide, we now have specific, quantitative data to support the rates of these rare side effects and how often they occur. Allergan Aesthetics is updating all Important Safety Information to reflect this data, and it will be made available to the public. Additionally, all patient consent forms will be updated to include quantitative information about these side effects. We consider this to be a rather good development, as it goes along with our mission to constantly evaluate new devices and protocols to improve outcomes, along with providing our patients with honest, up-to-date information.
If you have read the most recent news article regarding supermodel Linda Evangelista and her CoolSculpting® treatment(s), you might also be wondering: a) What exactly happened to her, and b) Is it safe? Details of Linda Evangelista’s treatment are unknown. We know that she developed paradoxical adipose hyperplasia (PAH), a known post-treatment complication associated with cryolipolysis where there is an increase in adipose tissue and an enlargement of the targeted area. Her statement includes negligence from her treatment provider, as they “failed to inform” her about the risk of PAH. PAH has been a known problem for many years and has remained a consistent inclusion as part of patient safety information. Its existence is not a surprise to us. Because of Linda’s status and unfortunate circumstances, this information is getting covered at an increasing rate by the media. So, to address your question on whether the treatment is safe, I am here to provide only facts: There are rare (1-10 out of 10,000; between 0.01% to 0.1%) and even rarer (1 out of 10,000; less than 0.01%) side effects that can happen after CoolSculpting®. One of those is PAH. As of November 8th, PAH reportedly occurs in about 1 of every 3,000 applications (0.033%). We have performed over 5,500 applications and have seen three cases of paradoxical adipose hyperplasia. Despite this, there are still hundreds of articles to support the long-term safety and efficacy of this technology, as well as the rates of rare and more rare side effects. In general, CoolSculpting® proves to be safe. The majority of our patients have been satisfied with their treatments and have positive stories to share.
As for me, I feel like a weight has been lifted off my shoulders as I clear the air about all things CoolSculpting®. Our goal is to provide an honest assessment of risks and potential complications, the same as any medical or cosmetic procedure. It is essential for us to share these updates with you to provide transparency and awareness. To our past and future patients, thank you for trusting us with your
To schedule a body shaping consultation please call/text 847.459.6400 or click here!