FDA Warns Against Use of Thermography in Place of Mammography

Mar. 29, 2019

When it comes to diagnosing breast cancer, time is of the essence. The sooner a diagnosis is achieved the sooner treatment can begin. If a diagnosis is delayed the risks of cancer spreading and becoming harder to treat—or even terminal—become much greater.

Women who are concerned about breast cancer diagnosis may have been misled into believing thermography can be used as a sole means of diagnosing breast cancer.

The US Food and Drug Administration (FDA), however, says it cannot and it should only be used along with mammography in making a diagnosis.

FDA Issues Thermography Warning

In a Safety Communication issued on Feb. 25, 2019, the FDA warned that some health spas, homeopathic clinics, mobile health units, and other facilities that offer health care may market breast thermography as a “standalone tool” used to screen for or diagnose breast cancer.

Of concern to the FDA is that some of these service providers have misinformed patients that a thermography scan can detect breast cancer years before mammography would or that it is especially beneficial in finding breast cancer in women who have dense breasts.

The FDA notes that none of those claims have any scientific backing, and there is even evidence that thermography is not at all effective in screening for breast cancer. The only tool that has been proven to effectively screen for and diagnose breast cancer—and to increase the chances of survival—is mammography.

The Society of Breast Imaging has issued a position statement on the use of thermography (or infrared imaging) noting that it does not support thermography as a screening or diagnostic tool. The society also argues that there are no studies that support using thermography breast cancer screening alone or as part of a breast cancer screening process with other devices or procedures.

Unfortunately, there may be some patients who not only opt for thermography screening but then avoid undergoing a mammogram believing it will not be beneficial for them. While there might not be adverse medical events linked to the use of a thermography scan, there is a risk that breast cancer will go undetected because women who undergo thermography then forego mammography thinking they do not have breast cancer and do not require screening.

Total Thermal Imaging sells thermography machines. Its president and co-owner, Linda Hayes, was interviewed in 2018 at a business expo by ABC News. Hayes reportedly told ABC News producers that no one needs a mammogram. Meanwhile, Dr. Joseph Mercola, who received a warning letter from the FDA about thermography, allegedly told women on his website not to use mammograms at all.

FDA Warns Thermography Providers About Inappropriate Claims

In addition to issuing its warning to women and health care providers, the FDA issued warning letters to a variety of service providers admonishing them for making inappropriate claims about thermography and marketing thermography devices for unapproved uses.

Among the entities that received warnings:

  • Total Thermal Imaging, Inc.
  • Thermogram Assessment Service
  • Meditherm
  • Nature’s Treasures
  • Dr. Joseph Mercola, Dr. Mercola’s Natural Health Center
  • Central Coast Thermography

What is Thermography?

Thermography produces images via an infrared camera that show heat and blood flow on or near the body’s surface. Those who support thermography argue that breast cancers cause a higher temperature within the breast due to metabolic activity and the detection of higher temperature in a portion of the breast could indicate breast cancer.

Though the FDA has approved thermograms for use, it has only approved them when they are used along with other screening methods or diagnostic tests such as mammography, not as standalone tools.

“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,” the FDA wrote.

Medical Injury Attorneys

Medical device makers have a responsibility to manufacture and sell devices that are safe and effective for use. They also have a responsibility to honestly market their devices and not mislead patients or the healthcare community about how the devices can be used.

Too many patients are harmed when they believe the misleading claims of medical device manufacturers and people looking to make money by offering services with no scientific backing.

Attorneys at Cutter Law are dedicated to helping patients who have been harmed by false medical claims. Our lawyers are here to help you determine the best course of action and to ensure you receive justice for wrongs done to you.

Contact our Sacramento and Oakland medical injury lawyers for a no-obligation consultation today. 

Personal injury and civil justice attorney Brooks Cutter is a leading advocate for consumer justice and protecting the rights of the severely injured. Brooks founded Cutter Law, P.C., with offices in Sacramento and Oakland, with…
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