FDA Warns Oncologists: Thermography No Substitute for Mammography

August 2011, Vol 2, No 5 - FDA Approvals, News & Updates


The FDA has issued a warning to healthcare providers against substituting breast thermography formammography in screening for breast cancer. Some providers prefer thermography over mammography because it does not exposewomen to radiation or breast compression. The FDA, however, points to the absence of valid evidence showing that when used alone,thermography is effective in detecting breast cancer.

The FDA has warned providers to stop making such claims in light of these claims appearing on provider websites. “Mammography is still the most effective screening method for detecting breast cancer in its early, most treatable stages,” said Helen Barr, MD, Director of the Division of Mammog – raphy 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,” she said.

The FDA has not approved any telethermographic devices as standalone screening or diagnostic tools for breast cancer, although the agency has cleared such devices for use as an additional method to confirm a breast cancer diagnosis. (June 2, 2011)