The U.S. Food and Drug Administration (FDA) has issued a warning regarding mammography quality at a Montana breast imaging center.
The agency became aware of problems associated with the quality of mammograms performed at Big Sky Diagnostic Imaging in Butte, MT, between November 2011 and November 2013 through a routine review of sample exams it conducted along with the American College of Radiology (ACR).
The review discovered poor-quality mammograms, although this does not necessarily mean that the results of the exams were inaccurate, the FDA said. The agency is recommending that patients who underwent mammography at the center after November 2011 speak to their healthcare providers about whether their mammograms should be repeated.
As of February 6, Big Sky Diagnostic Imaging is no longer performing mammography, its accreditation has been revoked, and its Mammography Quality Standards Act (MQSA) certificate is no longer valid, the FDA said.
