FDA is alerting women, healthcare providers, and others getting breast cancer screening that thermography is not an effective alternative to mammography and should not be used in place of mammography for breast cancer screening or diagnosis.
The agency said there is no valid scientific data to demonstrate that thermography devices, when used on their own or with another diagnostic test, are an effective screening tool for any medical condition, including the early detection of breast cancer or other diseases and health conditions. Mammography, which involves taking X-rays of the breasts, is the most effective breast cancer screening method and the only one proven to increase the chance of survival through early detection, FDA said.
But that has not stopped some health spas, homeopathic clinics, mobile health units, and other facilities from using thermography inappropriately as a standalone tool for breast cancer screening or diagnosis. FDA 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 unsupported and misleading claims such as thermography can find breast cancer years before it would be detected through other methods, or that thermography improves detection of cancer in dense breasts.
FDA said it is concerned that people will believe these 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, the agency noted.
Over the past eight years, FDA has issued warning letters to several facilities that have been caught making inappropriate claims about thermography. Most recently, the agency sent a warning letter to Total Thermal Imaging in La Mesa, CA on Feb. 22 for marketing and promoting thermography devices for unapproved uses.
On its website, Total Thermal Imaging advertises that clinical thermography is a simple test of physiology that relies on the sympathetic nerve control of skin blood flow and the ability of the sympathetic nervous system to respond to pain, pathology, injury, or dysfunction anywhere in the body. The clinic claims that while other diagnostics, such as ultrasound, radiography, and mammography show the body's structure or anatomy, digital infrared thermal imaging shows physiological and metabolic processes.
The agency issued similar warning letters to five other facilities between January 2011 and April 2017.