AUDIENCE: Family Practice, OBGYN, Oncology, Radiology, Patient
ISSUE: The FDA became aware of problems associated with the quality of mammograms performed at Big Sky Diagnostic Imaging, LLC, located in Butte, Montana. The FDA worked with the American College of Radiology (ACR) as it performed a routine review of a sample of mammograms performed by Big Sky Diagnostic Imaging, LLC that included images taken between November 20, 2011 and November 20, 2013. Results from that review included poor quality mammograms. The FDA will continue to monitor this issue and keep the public informed as new information becomes available.
This does not mean that the results of the examinations were inaccurate, but it does mean that patients should speak to their health care providers about whether their mammograms need to be repeated.
BACKGROUND: Under federal law (Mammography Quality Standards Act or MQSA), the FDA requires that all mammography facilities meet certain baseline quality standards and be certified to legally operate in the United States. This facility did not meet these standards for mammography quality. As of Feb. 6, 2014, the facility is no longer performing mammography. The ACR revoked its accreditation and its MQSA certificate is no longer valid.
RECOMMENDATION: The FDA recommends the following for patients who had a mammogram at Big Sky Diagnostic Imaging, LLC any time after Nov. 19, 2011:
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
[06/23/2014 - Safety Communication - FDA]