FDA Warns Against Thermography Breast Cancer Detection

The safety communication followed a warning letter issued on February 22, 2019, to Total Thermal Imaging (La Mesa, CA, USA) for marketing and promoting thermography devices for uses that have not received marketing clearance or approval.

The FDA clarified that thermography devices, also known as digital infrared (IR) imaging devices, have been cleared for marketing only for use with another screening or diagnostic test like mammography, and not for use as a standalone diagnostic tool, and that there is no valid scientific data to demonstrate that thermography devices are an effective screening tool for any medical condition, including the early detection of breast cancer or other diseases and health conditions. Thermography is not a substitute for regular mammograms, and should not be used in place of mammography for breast cancer screening or diagnosis.

The FDA also issued several recommendations for health care providers, including that they educate patients about the limitations of thermography, such as that the high false negative and false positive rates of thermography can provide misleading information that could result in a delayed diagnosis or unnecessary medical follow up. Providers should also discourage the use of thermography to diagnose or screen for breast cancer and talk to patients or caregivers about safe and effective ways to screen for breast cancer, including the benefits and risks of available testing options, clinical breast exams, and other breast imaging options such as ultrasound or MRI, or breast tissue biopsy.

“The FDA is aware that health spas, homeopathic clinics, mobile health units, and other health care facilities are using thermography inappropriately as a standalone tool for breast cancer screening or diagnosis,” stated the FDA. “These types of facilities provide false information that can mislead patients into believing that thermography can find breast cancer years before it would be detected through other methods or thermography improves detection of cancer in dense breasts.”

Thermography refers to digital infrared thermal imaging (DITI), a test that detects temperature changes on the surface of the skin using an IR thermal camera to record the areas of different temperature in the breasts. The camera displays these patterns as a heat map. As the presence of a tumor is associated with the excessive formation of blood vessels and inflammation in the breast tissue, the theory is that these changes should show up on the IR image as areas with a higher skin temperature.

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