CoolSculpting Elite System FDA Recall

 

FDA Class 2 recalls are issued when the use of a device is likely to cause temporary or reversible adverse health consequences or when the possibility of a device causing serious adverse health consequences is remote. The following devices have been recalled  CoolSculpting® Elite System The CoolSculpting® System SW Release 2.0, SW Release 3.0, SW Release 3.0.1, SW Release 3.0.2.

 

A ClassAction is currently in progress against Zeltiq Aesthetics and AbbVie who sold the CoolSculpting Elite System. The complaint is based on permanent damage to tissue, that occurs in patients that develop Paradoxical Adipose Hyperplasia. Paradoxical Hyperplasia occurs following treatment with CoolSculpting and causes cellular adaption which results in enlarged cells. This consequently results in an increase of the size of the tissue that has been affected.

 

The complaint states that PH has been reported to AbbVie, which can only be corrected with surgery. The lawsuit alleges AbbVie has assisted CoolSculpting providers with PH diagnosis and have paid patients to not pursue further legal claims after developing this condition.

 

“Thus, the only method of removing [Paradoxical Hyperplasia] is through invasive surgery,” the lawsuit, reads. “The condition is solely attributed to the CoolSculpting device.” 

 

The full safety information provided with all versions of the CoolSculpting device does clearly outline PH as a possible side effect along with a range of other possible risks and side effects that have been reported in clinical studies and commercial use.

 

 ‘Paradoxical hyperplasia: The gradual development of a visibly enlarged tissue volume, of varying size and shape, in the treatment area two to five months after the treatment. This is distinguished from temporary swelling and will not resolve on its own. The enlargement requires surgical intervention, such as liposuction, for correction.’ About CoolSculpting® Elite – full safety information.

 

The CoolSculpting devices have not been recalled in the UK. All non-surgical aesthetic treatments carry risks and complications. Prior to going ahead with any treatment you should discuss all the possible risks and complications, with your practitioner, as per the safety information provided with the device.

 

My Advice

 

Although non-surgical body contouring procedures may be effective, advancements with liposculpture procedures make liposculpture less painful and recovery faster. Liposculpture is normally performed as a day case procedure and has relatively low associated risks and complications when done by an experienced, specialist plastic surgeon. The other significant advantage with liposculpture are predictable results and advanced control over the fat cells removed in specific areas. Numerous plastic surgeons also provide a wide range of autologous fat transfer procedures which can be performed at the same time as liposculpture to smooth skin or add additional volume to cheeks or lips.