FDA Sounds Breast Thermography Warning

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imageBreast thermography should not be employed as a standalone screening tool independent of mammography for either breast screening or diagnosis, says the U.S. Food and Drug Administration (FDA) in a warning issued Thursday.

The FDA has cleared thermography—which utilizes infrared technology that shows patterns of heat and blood flow on or near the surface of the body--for use in conjunction with mammography as an additional tool for breast cancer screening and diagnosis. However, it is being touted by certain health care providers as an effective means of detecting breast cancer when used alone, the FDA says. Some of these providers, the agency states, have posted inappropriate clinical claims pertaining to thermography on their Web sites.

In response to the situation, the FDA has issued warning letters to some providers that have been making inappropriate claims. The agency is also urging women to have regular mammograms according to screening guidelines or as recommended by their health care provider; follow their health care provider's recommendations for additional breast diagnostic procedures, which could include thermography,but should also involve clinical breast exams, breast ultrasound, MRI, or biopsy; and remember that thermography is not a substitute for mammography and, as such, should not be used by itself for diagnosis