FDA Warns Thermography Not a Substitute for Mammography to Screen for Breast Cancer

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Neither the American College of Radiology (ACR) or the the US Preventive Services Task Force recommend breast thermography as a method to screen for breast cancer. However, some health care providers have been promoting the use of breast thermography as an effective means of detecting breast cancer.

The U.S. Food and Drug Administration has stepped in, warning women not to substitute breast thermography for mammography to screen for breast cancer.

Thermography is does not involve an x-ray of the breast as mammography does. Thermography produces an infrared image that shows the patterns of heat and blood flow on or near the surface of the body.

Some health care providers claim thermography is superior to mammography as a screening method for breast cancer because it does not require radiation exposure or breast compression. Some have even made these claims on their websites.

The FDA has issued warning letters to these health care providers who have been promoting the inappropriate use of breast thermography. The letters instructed the providers to cease making claims that thermography devices, when used alone, are an effective means of detecting breast cancer.

The FDA is unaware of any valid scientific evidence showing that thermography, when used alone, is effective in screening for breast cancer.

A study by Feig et al in 1977 found thermograpy only detected 39% of breast cancers compared to mammography which detected 78% of breast cancers. Both technologies have changed over time, but a review by Dr. Gregory Plotnikoff in 2009 noted “Despite various studies that suggest positive results for thermography, there has never been a major randomized controlled trial to determine baseline measurements of sensitivity and specificity.”

To date, the FDA has not approved a thermography device (also referred to as a telethermographic device) for use as a stand-alone to screen or diagnose breast cancer. The FDA has cleared thermography devices for use only as an additional diagnostic tool for breast cancer screening and diagnosis. Therefore, FDA says, thermography devices should not be used as a stand-alone method for breast cancer screening or diagnosis.

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“Mammography is still the most effective screening method for detecting breast cancer in its early, most treatable stages,” said Helen Barr, M.D., director of the Division of Mammography Quality and Radiation Programs in the FDA’s Center for Devices and Radiological Health. “Women should not rely solely on thermography for the screening or diagnosis of breast cancer.”

While ACR and USPSTF disagree on when screening mammograms should begin, they both recommend mammograms and not thermography as the method for screening.

The USPSTF 2009 breast screening guidelines recommend:

  1. The USPSTF recommends biennial screening mammography for women aged 50 to 74 years.
  2. Women younger than 50 should discuss their individual needs, benefits, and harms with their doctors and decide for themselves.
  3. The USPSTF concludes that the current evidence is insufficient to assess the additional benefits and harms of screening mammography in women 75 years or older.
  4. The USPSTF recommends against teaching breast self-examination (BSE).
  5. The USPSTF concludes that the current evidence is insufficient to assess the additional benefits and harms of clinical breast examination (CBE) beyond screening mammography in women 40 years or older.
  6. The USPSTF concludes that the current evidence is insufficient to assess the additional benefits and harms of either digital

mammography or magnetic resonance imaging (MRI) instead of film mammography as screening modalities for breast cancer

ACR recommends screening mammography should begin at age 40 for women with average-risk of breast cancer. Women at higher-risk should begin by age 30, but no sooner than 25.

Sources
Food and Drug Administration

Thermography, Mammography, and Clinical Examination in Breast Cancer Screening: Review of 16,000 Studies; Stephen A. Feig, M.D., et al; Radiology, 122, 123-127, January 1977; doi: 10.1148/122.1.123

Emerging Controversies in Breast Imaging: Is There a Place for Thermography? – Commentary; Gregory Plotnikoff, M.D., M.T.S., and Carolyn Torkelson, M.D., M.S.; Minnesota Medicine, December 2009

U.S. Preventive Services Task Force (USPSTF); December 2009

Breast Cancer Screening With Imaging: Recommendations From the Society of Breast Imaging and the ACR on the Use of Mammography, Breast MRI, Breast Ultrasound, and Other Technologies for the Detection of Clinically Occult Breast Cancer;
Carol H. Lee, et al; Journal of the American College of Radiology - January 2010 (Vol. 7, Issue 1, Pages 18-27, DOI: 10.1016/j.jacr.2009.09.022)

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