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FDA Safety Alert: Thermography is Not an Alternative to Mammography

The FDA is warning that thermography is not a replacement for screening mammography and should not be used by itself to diagnose breast cancer. Certain health care providers and websites are claiming that thermography is superior to mammography as a screening method for breast cancer, because it does not require radiation exposure or breast compression. Some websites also claim that thermography can detect precancerous abnormalities and diagnose breast cancer before mammography and that compressing the breast during mammography will cause or spread cancer by pushing cancer cells into additional locations in the body.

 

There is no scientific evidence showing that thermography, when used alone, is effective in screening for breast cancer, according to the FDA. Thermography devices are approved only for use as adjunctive diagnostic tools for breast cancer screening and diagnosis. Therefore, they should not be used as a stand-alone method for breast cancer screening or diagnosism. Women need to follow current FDA screening guidelines, which recommend receiving mammograms.

 

Additional details can be found at http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm257259.htm.


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