FDA Clearance For CoolSculpting
CoolSculpting – Yes it’s FDA Approved for Banishing the Bulge
CoolSculpting (originally branded Zeltiq) is FDA approved for fat reduction. Many technologies start off FDA approved for one purpose and end up being used for something totally different – Just look at Botox, Latisse or Viagra! Botox was originally used for eye twitching, Latisse for glaucoma and Viagra was a heart medication.
Because CoolSculpting can safely lower the temperature of fat cells – while not harming skin cells – the procedure can injure the fat cells enough to cause them to self-destruct. CoolSculpting is “area-defined” so it can be used specifically for fat bulges that can be grasped between the cooling plates.
An hour is the magic amount of time for a procedure and patient studies through ultrasound measurement show a 20-25% reduction in the fat layer. (Rebecca Fitzgerald, MD, Los Angeles Dermatologic Surgeon)
Zeltiq – CoolSculpting is now FDA approved for fat reduction!
The CoolSculpting device enables us to selectively target and destroy fat cells in localized areas such as the abdomen and flanks by selectively cooling the fat cells in these areas. Ideal candidates are those who exercise, maintain a steady weight, but are still unable to reduce fat in these stubborn localized areas. (Lori Stetler, MD, Dallas Dermatologic Surgeon)
Zeltiq CoolSculpting is FDA cleared for fat removal
Initially the Zeltiq device had an indication for chilling the skin but as the company performed testing and then provided data to the FDA , they were granted FDA clearance for an indication of fat removal in Sep. 2010. (Ronald Shelton, MD, Manhattan Dermatologic Surgeon)
The FDA, in September of 2010, gave clearance to CoolSculpting as a fat reducing device. Over 165,000 treatments worldwide have been given to patients without any significant problems.
FDA Clearance For The CoolSculpting Treatment
As a skin cooling device, the fat removal occurs because of this reason. When the skin is cooled, the fat cells actually die and are eliminated from the body causing a significant reduction in the amount of fat in the area treated. (Jeffrey E. Schreiber, MD, FACS, Baltimore Plastic Surgeon)
Zeltiq does not actually REMOVE fat
it may be semantics, but zeltiq actually intiates a process called “apoptosis” otherwise known as ‘programmed cell death’ that leads fat to ultimately break itself down. intially after the treatment, the fat is still completely viable.
however, with time the fat cells will actually breakdown and be absorbed by the body. the fatty layer will become noticeably thinner. (Eric Chang, MD, Baltimore Plastic Surgeon)
Zeltiq is approved for fat reduction!
FDA has agreed that the studies using Zeltiq for fat reduction are compelling enough to grant approval. This only occurred in the last few months but by now the website should have been updated.
FDA approval is important however sometimes medical devices are used “off label” prior to getting the official nod. Prior to approval it is legal and ethical for the machine to be used by a qualified licensed physician as long as there is good evidence that it is effective and if he/she discloses to the patient the reason for the “off label” use. (Susan Van Dyke, MD, Paradise Valley Dermatologic Surgeon)
Zeltig coolscultping is used for fat removal
Zeltiq’s Coolsculpting is a recently approved new procedure using cryolipolysis to permanently get rid of fat in areas that are typically resistent to exercise and diet. It is used because it is a safe, effective approach to localized fat reduction. (Steven Hacker, MD, West Palm Beach Dermatologic Surgeon)
Zeltiq and many other devices and medications are used for non-FDA approved uses
Zeltiq and many other devices and medications are used for non-FDA approved uses. Physicians are allowed to use devices and medications for other uses, as long as they are approved by the FDA for something.
The FDA deems that the product is also safe. The company that creates the device or drug however cannot market it for non-FDA approved uses, but physicians can. (Lorrie Klein, MD, Laguna Niguel Dermatologic Surgeon)
Off-Label use of Zeltiq
In the US ‘off-label’ use of devices and drugs is common. You are 100% correct that Zeltiq is only FDA approved as a skin cooling device, but now that it has proven that it can reduce the thickness of the fatty layer it will most likely be used for fat reduction as its primary purpose. (Sam Naficy, MD, FACS, Seattle Facial Plastic Surgeon)
Zeltiq and FDA
Zeltiq has been approved for the FDA for the specific application of skin cooling. However, as an FDA approved medical device, physicians in the US are permitted to use Zeltiq in an ‘off label’ manner for cryolipolysis.
Zeltiq has been safely used in an off-label manner for body contouring by clinics in the USA for a few years now. There are a number of devices and drugs that are routinely used in an ‘off label’ manner.
Botox, for example, was initially FDA approved for cosmetic use for glabellar wrinkles only. Physicians quickly learned to use it safely all over the face for other cosmetic applications. As much as we all complain about the FDA, it is nice that off-label uses are permitted in the USA: it leaves the ultimate decision and responsibility about efficacy and patient safety up to the treating physician caring for a patient.
That is where such decisions belong. (Scott C. Sattler, MD, FACS, Seattle Plastic Surgeon)