The U.S. Food and Drug Administration (FDA) issued a warning letter to Total Thermal Imaging Inc., of La Mesa, Calif., and its president and co-owner, Linda Hayes, for illegally marketing and distributing an unapproved thermography device as a sole screening device for breast cancer and other diseases.
The FDA also issued a safety communication to warn patients that thermography is not cleared by the FDA as an alternative to mammography and should not replace mammography for breast cancer screening or diagnosis.
Thermography is a noninvasive tool that uses an infrared camera to produce images that show the patterns of heat and blood flow on or near the surface of the body. Thermography devices, also known as digital infrared imaging devices, have been cleared by the FDA only as an adjunctive tool, meaning it should only be use alongside a primary diagnostic test like mammography, not as a standalone screening or diagnostic tool.
The FDA said it is aware that health spas, homeopathic clinics, mobile health units, and other healthcare facilities are using thermography inappropriately as a standalone tool for breast cancer screening or diagnosis. The agency said it 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.
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 are true or have any valid scientific evidence to support them, according to the FDA. In addition, the Society for Breast Imaging notes a lack of evidence that thermography has any effective role in breast cancer screening.
Mammography is the most safe and effective tool for screening and diagnosis of breast cancer, and the only method proven to increase the chance of survival through earlier detection, the agency said.
The FDA is concerned that people will believe the misleading claims about thermography and not get mammograms to screen for breast cancer. People who choose thermography instead of mammograms may miss the chance to detect cancer at its earliest and most treatable stages.
For more information, visit PINK Breast Center and talk with one of our qualified professionals about your options.
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