FDA Warns Thermography Is Not a Substitute for a Mammogram

Experts say the technique should only be used in connection with other breast cancer screening processes such as mammography.

It doesn’t touch your skin or compress your breast like a mammogram.

There’s no radiation.

But thermography is no substitute for mammography, cautions the Food and Drug Administration (FDA).

On February 25, the agency issued a warning to women, patients recommended for breast cancer screening, healthcare providers, and cancer treatment advocacy organizations.

“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 statement reads.

Thermography involves the use of infrared cameras to show patterns of heat and blood flow. Images show temperature changes in different areas of the breasts.

The FDA approved thermography devices in 1982, but only for use with other tests such as mammography, not as a stand-alone diagnostic test for breast cancer.

One day after the FDA warning, the American Academy of Thermology (AAT) issued a position statement on breast thermography.

“There are established indications for breast thermography when performed in adherence with AAT Guidelines,” said Executive Director Jeffrey J. Lefko said in the statement.

“The AAT does not condone representations or evaluations that are performed in contradiction to these guidelines, including the fundamental fact that breast thermography is not and has never been endorsed by the AAT as a stand-alone assessment,” he continued.

Misleading claims

Thermography is offered at health spas, homeopathic clinics, mobile health units, and other healthcare facilities.

The FDA says it has received reports that some facilities are providing inaccurate, unsupported, and misleading claims.

These claims can lead patients to believe that thermography is an alternative or better option than mammography.

In response, the FDA issued warning letters to providers to immediately stop making inappropriate claims.

It’s not the first time the FDA has addressed this issue. The most recent warning letter went to Total Thermal Imaging Inc. in California on February 22.

Among the violations, the FDA says the company’s website and literature claim that thermography is an alternative to mammography “and is far more efficient at detecting cancer.”

Failure to promptly correct all violations could result in regulatory action by the FDA.

Doctors respond to FDA warning

Dr. Laurie Margolies is section chief of breast imaging at Mount Sinai Health System and a professor of radiology at Icahn School of Medicine at Mount Sinai in New York.

She’s in complete agreement with the FDA’s warning.

“There is no credible scientific evidence to support thermography. I agree with the Society of Breast Imaging position and do not support the use of thermography/infrared imaging of the breast as either a screening or diagnostic tool,” she told Healthline.

Margolies said that false positives and false negatives can lead to significant delays in diagnosis and the usefulness of thermography has not been proven.

“There are many issues with the studies that have been published, such as how abnormal areas detected by thermography were aspirated or biopsied or localized in the breast,” she continued.

Dr. Richard Reitherman is medical director of breast imaging at MemorialCare Breast Center at Orange Coast Medical Center in California and board member of the National Accreditation Program for Breast Centers (NAPBC).

“Valid uses for thermography may include musculoskeletal applications,” he told Healthline.

“But thermography has no place at all in screening, diagnosis, or following therapy in breast cancer. X-ray mammography is the only scientifically validated test to reduce breast cancer mortality,” said Reitherman.

Why some women choose thermography

Why would someone choose thermography over mammography?

Reitherman said their reasons are diverse.

“Some have a fear of radiation. Some don’t like the discomfort of breast compression. Some had a very unpleasant experience with a mammogram. And there’s a group of people who are just alternative health aficionados, so to speak,” he explained.

Reitherman said that doctors don’t recommend thermography.

“I think the catch is that people don’t seek out thermography, but it’s connected to something like a spa, as an add-on service. They’re promoted on those websites as being like a mammogram. That’s my take. In the population we serve, it’s very unusual,” said Reitherman.

Margolies added that those who talk about the harms of mammography are mostly talking about transient anxiety caused by being recalled for another mammogram or ultrasound.

“Others discuss the detection of early cancer or precancerous lesions which may or may not ultimately progress to a finding that can spread and cause morbidity and mortality,” she continued.

“These harms are mitigated by the lifesaving benefits of mammographic screening,” said Margolies.

Doctors recommend screening mammography

When it comes to mammograms, Margolies said that women and their physicians continue to be confused by conflicting guidelines from multiple medical groups.

“Yet, all groups agree that if the goal is to prevent the most breast cancer deaths, annual screening mammography beginning at age 40 is the optimal screening regimen,” she said.

“Regular annual screening mammography reduces breast cancer deaths by at least 40 percent. Since screening mammography began to be offered in the 1980s, the breast cancer death rate in the United States has decreased by 43 percent,” said Margolies.

She added that women with dense breasts and those with an elevated risk can have supplemental screening with ultrasound, MRI, or molecular breast imaging.

There are a few facts Margolies wants all women to know.

“One in eight women in the United States will be diagnosed with breast cancer in their lifetime. Most women diagnosed with breast cancer do not have a family history of breast cancer and are not at high risk,” she said.

Margolies noted that some women should start screening earlier and a risk assessment at age 30 can help determine if this is a wise choice.

“Yearly screening mammography beginning at age 40 is lifesaving and is worth the discomfort and anxiety. Supplemental screening with ultrasound or MRI can also be extremely useful for some women,” she said.

Reitherman said that thermography is not covered by Medicare or many insurance companies as standard breast care. On the other hand, Medicare pays for screening mammograms and the Affordable Care Act also mandated coverage for screening mammograms.

Reitherman strongly recommends against having thermography. Instead, he recommends screening mammograms in a facility certified by one of three vetting programs.

They are the National Accreditation Program for Breast Centers, where Reitherman is a board member, National Quality Measures for Breast Centers (NQMBC), and the American College of Radiology.

“The biggest controversy about mammograms is whether you should have it done every one or two years, or when to start having them, not the procedure itself,” said Reitherman.