FDA Warns Patients, Providers About Thermography Imaging to Diagnose Cancer

The FDA is warning patients and providers not to use thermography in place of mammography to detect, diagnose, or screen for breast cancer.

Thermography devices, which use an infrared camera device to show heat and blood flow on or near the surface of the body, have been cleared by the FDA only for use with another screening or diagnostic test (such as mammography) and should not be used alone to diagnose patients. However, in a recent statement, the agency noted that they are aware of health spas, homeopathic clinics, mobile heath units, and other facilities that are using thermography alone as a screening or diagnostic tool.

“The FDA has received reports that these types of facilities provide false information that can mislead patients into believing that thermography is an alternative or better option than mammography,” the FDA said in the statement. “Some facilities make inaccurate, unsupported, and misleading claims, such as thermography can find breast cancer years before it would be detected through other methods or thermography improves detection of cancer in dense breasts.”

None of these claims have been proven true. However, companies such as Total Thermal Imaging, Inc., were found to have been marketing thermography as a standalone diagnostic device for breast cancer in its “Thermography Business Package,” which claims that, “Thermal Imaging is intended for early detection of the diagnosis of many disorders, including breast cancer, inflammatory breast cancer, pre-stroke, heart disease, deep vein thrombosis, reflex sympathetic dystrophy/complex regional pain syndrome, back, leg, or headache, and even unexplained pain, TMJ and other disease.”

Along with the general statement, the FDA also issued a warning letter to Total Thermal Imaging, Inc., giving the organization 15 days to correct the noted violations, as well as how the firm plans on preventing these violations and other similar ones from occurring again.

“Your firm should immediately cease distribution of the Thermography Business Package and take prompt action to correct the violations addressed in this letter,” the FDA wrote to the president of Total Thermal Imaging.

Oncology nurses and other healthcare providers can play a pivotal role in ensuring that patients are well-educated and do not seek thermography as their only screening and diagnostic tool for breast cancer. The FDA suggests that providers talk to patients and caregivers about the high rate of false negatives and false positives, as well as other safe and effective ways to screen for cancer.

“The FDA is closely monitoring adverse event reports associated with thermography and will take additional steps necessary to address the risks associated with use of these products,” the statement read. “We are committed to protecting and promoting access to safe and effective breast cancer screening devices.”