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Thermogram No Substitute for Mammogram

Posted on Thu, Jul 07, 2011

Example of a thermogram image.

Despite widely publicized claims to the contrary, thermography should not be used in place of mammography for breast cancer screening or diagnosis.

The Food and Drug Administration (FDA) says mammography— an X-ray of the breast—is still the most effective way of detecting breast cancer in its earliest, most treatable stages. Thermography produces an infrared image that shows the patterns of heat and blood flow on or near the surface of the body.

The agency has sent several warning letters to health care providers and a thermography manufacturer who claim that the thermal imaging can take the place of mammography.

Web sites have been touting thermography as a replacement for mammography and claim that thermography can find breast cancer years before it would be detected by mammography.

The problem is that FDA has no evidence to support these claims.

"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 there is plenty of evidence that mammography is effective in breast cancer detection, there is simply no evidence that thermography can take its place," said Barr.

Thermography devices have been cleared by the FDA for use as an adjunct, or additional, tool for detecting breast cancer. Toni Stifano, a consumer safety officer in FDA’s Center for Devices and Radiological Health, explains that this means thermography should not be used by itself to screen for or to diagnose breast cancer.

The National Cancer Institute (NCI), part of the National Institutes of Health, estimates that about 1 in 8 women will be diagnosed with breast cancer sometime in her life.

The greatest danger, says Stifano, a breast cancer survivor herself, is that patients who substitute thermography for mammography may miss the chance to detect cancer at its earliest stage. There has been a steady decline in breast cancer deaths and one of the reasons is early detection through mammography, says FDA. 

As for concerns about exposure to radiation from a mammogram, evidence shows that the benefits outweigh the risks of harm, especially when compared to the danger of breast cancer.

FDA is advising patients to continue to have regular mammograms according to screening guidelines or as recommended by their health care professional.

Patients are also advised to follow their health care professional's recommendations for additional diagnostic procedures, such as other mammographic views, clinical breast exam, breast ultrasound, MRI or biopsy. Additional procedures could include thermography.

This year alone, the agency has sent warning letters to the following practitioners and manufacturer making misleading claims about thermography: 

FDA’s position on thermography is shared by prominent organizations active in the fight against breast cancer, including the Susan G. Komen for the Cure, a nonprofit that has raised billions of dollars for education and research, and the American Cancer Society.

This article appears on FDA's Consumer Updates page7, which features the latest on all FDA-regulated products.

Posted June 2, 2011

View the PDF of this story here. Adobe Reader is required.


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Commentary on the Latest Swedish Two-County Trial Report by Daniel Kopans, MD

Posted on Thu, Jul 07, 2011

June 28, 2011

Commentary on the latest Swedish Two-County Trial Report by Daniel B. Kopans, MD Swedish Two-County Trial: Impact of Mammographic Screening on Breast Cancer Mortality during 3 Decades. Tabar L, Vitak B, Chen THH, et al. Radiology 2011; pre-release (ahead of print publication)Photo of Daniel Kopans, MD, Professor of Radiology, Harvard Medical School

View the original commentary here on SBI's Web site

"Mammography screening is one of the major medical advances of the last 50 years. The death rate from breast cancer had been unchanged for at least 50 years. Mammography screening began at a national level in the U.S. in the mid-1980’s, and, as would be expected, the death rate began to decline in 1990. Since then the death rate has decreased by over 30%. Therapy has helped to reduce deaths, but therapy only saves lives when cancers are found early. Data from the Netherlands and Sweden have clearly shown that it is screening that accounts for most of the decrease in deaths. The major impact of screening has been lost by the numerous controversies that have swirled around mammography. For many years the debate centered on whether or not screening could save lives. Once this became apparent (although there continue to be those who doubt the clear scientific evidence), the debate has been over whether or not there is benefit from screening women ages 40-49. Following the first randomized, controlled trial of breast cancer screening performed within the Health Insurance Plan of New York (HIP) in the 1960’s, a large study was undertaken in Sweden that involved women in two counties and has been named the Two County Trial. Over 130,000 women were involved in the trial. A little more than half of the women were invited to be screened while the other half were not invited, but got the standard health care at the time. This trial was designed to see if high quality mammography screening alone, without clinical breast examination (CBE), could reduce deaths from breast cancer. The first publication from the Two County trial in the mid-1980’s clearly showed a decrease in deaths for screening from age 40-74, and this resulted in the start of screening in the U.S. and around the World.

This latest paper with 29 years of follow-up of the Two County Trial not only confirms the fact that screening with mammography, alone, can save thousands of lives, but it also shows that the benefit continued even after the screening ended. Fortunately, most breast cancers do not kill women quickly. The very fast growing cancers, unfortunately, are not often detected by screening periodically, and many of these are not detected early enough to save lives. However, there are many cancers that, if not found early enough will, ultimately kill women 5, 10, or more years after diagnosis. These are the cancers which, if found early, can prevent a woman from dying later in life. This recent study from the Two County Trial clearly shows that these are the lives that are being saved by screening. Even though many women die from their breast cancers years after their cancers are diagnosed, screening prevents many of these deaths and even 20 years after screening fewer women die in the screened group. The benefit of screening, in preventing these deaths is clear, and it is also clear that the benefit came from screening women beginning at the age of 40. Mammography screening is not perfect. It does not find all cancers and does not lead to a cure for all women, but screening beginning at the age of 40 saves thousands of lives.

The United States Preventive Services Task Force, unfortunately, caused a great deal of confusion by suggesting that women did not need to be screened until the age of 50. It is now clear that this would result in tens of thousands of deaths that could be prevented by annual screening beginning at the age of 40. This latest paper again confirms the value of screening beginning at the age of 40.

With regard to the “number needed to screen” to save a life (NNTS). This was raised by the US Preventive Services Task Force because they were prohibited, by their charter, from doing “cost/benefit” analysis. It was a way for them to suggest that screening younger women was not worth the cost. An individual woman gets screened only once a year so that the NNTS is fairly meaningless to her. Adding insult to injury, the USPSTF used the wrong data to determine NNTS. They used numbers for the randomized, controlled trials which were actually the number of women needed to be invited to be screened (many refused the invitation). This latest study provides the actual number of women needed to be screened and is far more accurate and smaller than that used by the USPSTF.

The USPSTF clearly based their guidelines on scientifically unsupportable analyses. They should, once more, support annual screening beginning at the age of 40."


Daniel B. Kopans, M.D. Professor of Radiology, Harvard Medical School
Senior Radiologist, Breast Imaging Division
Department of Radiology, Massachusetts General Hospital
Avon Comprehensive Breast Evaluation Center
ACC Suite 240
15 Parkman Street
Boston, MA 02114

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Society of Breast Imaging and ACR Joint Commentary on Swedish Two-County Trial

Posted on Thu, Jul 07, 2011

June 29, 2011 - A landmark study published in the July 2011 issue of Radiology, one of the leading journals for medical imaging, should put an end to the controversies over the effectiveness of mammography screening.  The ACR is the American College of Radiology. Click here to visit their Web site and learn more about their accreditation programs.

The Society of Breast Imaging logo.


The study, known as the Two County Trial in Sweden, is a randomized, controlled trial (RCT), one of the most rigorous types of scientific studies available to evaluate the efficacy of medical tests.  The 29-year follow-up is the longest for any mammography RCT. More than 130,000 women from 40 to 74 years of age were included in the trial. Roughly half were screened over a seven year period.   

Essentially, the trial compared the death rate from breast cancer from two randomly assigned groups of women: women who were invited to be screened with mammography alone, compared with a control group of women who were not invited to be screened at all.  About 85% of the women invited were actually screened.  The death rate was 30 percent lower among the women invited to be screened.   


This latest paper not only confirms that screening with mammography alone can save thousands of lives, but furthermore, the mortality benefit continues over time.  More than half of the cancer deaths in this study occurred more than 10 years after screening began, demonstrating an enduring effect for almost three decades.  

The Two County Trial screened women in their forties about every 24 months, and women aged 50-74 about every 33 months.  The mammograms were obtained using only a single view of each breast.  If the American Cancer Society recommendations were to be followed (screening annually starting at age 40), with two views of each breast, the number of lives saved is likely to be higher than was seen in this trial.  For women who actually participate in screening, the benefit is likely to be even higher.  Mammography screening is not perfect.  It does not find all cancers and does not lead to a cure for all women, but screening beginning at the age of 40 saves thousands of lives each year.


In contrast, the US Preventive Services Task Force (USPSTF) issued guidelines in 2009 suggesting that women need not begin screening until the age of 50. They used an estimate of only a 15 percent decrease in breast cancer deaths in their calculations.  Had they used the estimate of 30 percent, they may have reached different conclusions and made different recommendations.  Furthermore, the estimate of the “number needed to screen” to save a life (NNS) from this latest study is far more accurate, and much lower, than that estimated by the USPSTF for women under the age of 60 years.   

The USPSTF should withdraw its 2009 guidelines and support annual screening, beginning at the age of 40, for all women.  Physicians who have been asked by the USPSTF to discuss screening with each of their younger patients would be wise to consider the results of this important screening trial.  


While treatment for breast cancer has improved over the years, early detection with mammography is crucial to better results. Mammography screening is clearly the main reason that deaths from breast cancer have decreased in the United States since 1990.  

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