FDA Warns of Problems with Montana Mammography Lab Results

Federal health officials indicate that a diagnostic imaging lab in Montana may have produced poor quality mammogram results, which may raise concerns for patients examined since November 2011.  

The FDA issued a safety communication on Monday, warning patients who had mammograms performed by Big Sky Diagnostic Imaging, LLC in Butte, Montana that there may be quality problems with the mammograms the lab has performed.

According to the FDA warning, the quality problems could affect any patient who had a mammogram at Big Sky Diagnostic at any time after November 19, 2011. However, the FDA stressed that the warning does not automatically mean that the examinations were inaccurate.

The agency recommends that patients who had mammograms done at the laboratory speak with their health care provider to determine if they need to get retested.

The laboratory had its accreditation revoked by the American College of Radiology (ACR) and stopped performing mammograms in February. It also no longer has a Mammography Quality Standards Act (MQSA) certificate.

The facility lost the ACR accreditation following a routine review of mammogram samples. ACR and FDA investigators determined that some mammograms from Big Sky Diagnostic Imaging taken from November 20, 2011 to November 20, 2013 failed to meet the baseline quality standards of mammograms required for a facility to operate in the United States.

Mammograms are low-dose x-ray images of the breasts used to detect breast cancer in its earliest stages. An incorrect mammogram could lead to a missed opportunity to treat breast cancer when it is at its most treatable and could negatively affect the quality of life or lifespan of the patient. Conversely, a poor quality mammogram that returns a false positive could lead to unnecessary testing and cancer treatments.