CoolSculpting Side Effects May Be Underreported

 

 

Disclaimer: While we are neither for nor against Coolsculpting, we always feel clients should be fully informed of the pro's and con's of any treatment they are considering, and will share media information from time to time. It's your body and your health, so you should always have as much information as possible before you make any decision.

WHAT IT IS

Coolsculpting utilizes Cryolipolysis which involves applying a cooling device to specific areas of the body to freeze and destroy fat cells. Over multiple treatment sessions, the body absorbs the eliminated fat cells. However, recent reports have surfaced regarding the potential risks associated with the procedure, specifically paradoxical adipose hyperplasia.

WHATS THE CONCERN?

Paradoxical adipose hyperplasia, or PAH, is a side effect of CoolSculpting characterized by the growth, hardening, and lodging of fat cells, often resembling the shape of the device's applicator. This condition may require corrective surgery to address. (Clients are almost always told Paradoxical adipose hyperplasia is a "rare" and unlikely outcome.)

Several studies and interviews with medical professionals allegedly reveal discrepancies between the reported incidence of PAH by the manufacturer and real-world observations. Physicians have observed a higher frequency of PAH in their practices, attributing it to underreporting and misdiagnosis. The delayed onset of symptoms and subtle nature of the condition often lead patients to believe they have gained weight rather than associating it with CoolSculpting.

The Food and Drug Administration (FDA) relies on hospitals, doctors, consumers, and device manufacturers to report adverse events related to medical devices. However, this reporting system has been criticized for its limitations, as private doctors' offices and consumers are not obligated to report incidents. This leads to concerns about the accuracy of data and the overall safety monitoring of medical devices such as CoolSculpting.

The controversies surrounding CoolSculpting, particularly the possibility of an increased risk of paradoxical adipose hyperplasia, raise important questions about patient safety, reporting practices, and regulatory oversight.

 

 

As a potential patient considering CoolSculpting or any medical procedure, it is crucial to thoroughly research the treatment, consult with medical professionals, and weigh the potential benefits against the reported risks. Transparency, accurate reporting, and informed decision-making are paramount to ensuring patient well-being in the cosmetic and medical industry.

Here's the LINK to the NYTIMES article 


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