The US-FDA
has issued a consumer health alert that thermogram breast cancer screening test
is no substitute for mammography because of lack of scientific evidence in
favor of thermogram.
This alert
was issued in wake of reports received from many healthcare centers and patients
that many providers are misleading patients into believing that thermogram can
be a substitute for mammography.
Helen J.
Barr, M.D., director of the Division of Mammography Quality Standards in the
FDA’s Center for Devices and Radiological Health said, “Plenty of evidence
shows that mammography is still the most effective screening method for
detecting breast cancer in its early, most treatable stages. You should not
rely solely on thermography for the screening or diagnosis of breast cancer.”
Those patients
who are screened with thermogram may be falsely assured that they do not have cancer
as it has high false negative results. Similarly, patients may receive a false diagnosis
of breast cancer when in fact they do not have any lesion.
Thermography
was only cleared by FDA as an adjunct tool, to be used with a primary screening
method. Some women prefer to get the test done as it is painless and does not
expose the patient to radiation.
FDA also
stressed that claims by websites that thermography detects cancers earlier than
other screening methods does not have any scientific evidence.
FDA has further
taken regulatory action against manufacturers of thermography devices and healthcare
providers who are misleading patients to believe that thermography can replace
mammography.
FDA has put
the alert on consumer update page and it continues to monitor the situation.
Media Courtesy: FDA
