Allergan Aesthetics provided the following statement in full to the New York Times in response to their recent inquiry for a story.
Using technology developed by scientists from Harvard University, CoolSculpting® was cleared by the FDA in 2010 for noninvasive subcutaneous fat reduction and has been well studied with more than 100 scientific publications. More than 17 million treatments have been performed worldwide.*
Providing innovative, safe, and effective products has always been a top priority at Zeltiq and Allergan Aesthetics. The clinical study program for CoolSculpting® included robust procedures for adverse event reporting. Since FDA clearance, reported serious adverse events are closely monitored and we are compliant with all adverse event reporting requirements.
Paradoxical Hyperplasia (PH), a rare adverse event, has been well documented within CoolSculpting® information for healthcare providers and patients since 2012, shortly after receiving the first reported case in late-2011. All procedures, including those which involve the use of a medical device, have potential side effects. We encourage doctors and patients to discuss potential benefits and risks before any procedure. While the cause of PH is currently unknown, we have continued to inform healthcare providers and provide educational materials for them to discuss PH risk with patients. In addition, we offer a comprehensive training and education curriculum in partnership with CoolSculpting® providers.
Important Safety Information included on the CoolSculpting® consumer website and patient consent forms provided to CoolSculpting® practitioners includes the current reported rate of about 1 out of 3,000 treatments (0.033%), which includes all reported PH cases since 2015 and remains within the classification of “rare adverse events”. As disclosed, reported rates of rare adverse events are calculated by the number of adverse events reported compared to the number of treatment cycles used globally. This is the standardized accepted method of communicating post-marketing adverse events that are rare in frequency and do not reflect variances in treatment regimens that will impact any validity of patient-level data.
We continue to review scientific literature related to PH and update provider materials as new data emerges. For more background and education, we direct you to additional, publicly available information:
1. We have the history of cryolipolysis and CoolSculpting on our website.
2. In addition, to the consumer website, we have a site with more information tailored to health care providers.
* Data based on the number of treatment cycles sold.
Disclaimer
The quotes below reflect the physicians’ personal opinion on their professional use of CoolSculpting.
“I served as the principal investigator in the original FDA Clinical trials for dozens of different medical devices in the aesthetics industry, including 20+ CoolSculpting trials. I have been impressed with Allergan Aesthetics’ commitment to advancing the cosmetic field with the highest integrity. During the past 13 years our clinic treated thousands of CoolSculpting patients with over 20,000 cycles providing high patient satisfaction and transformational changes.” – Dr. Suzanne Kilmer, MD, Founder, Laser & Skin Surgery Center of Northern California, Clinical Professor, University of California, Davis
“I have been privileged in my career to work with the leading medical technology companies in the world. Although there is no medical procedure that is without risk, CoolSculpting has revolutionized non-surgical body contouring and, with a balanced risk/reward profile, remains my choice for patients.” – Dr. A. Jay Burns, MD, Resurrect Skin MD