FDA issues warning about problems at Montana mammo clinic

The U.S. Food and Drug Administration has issued a safety communication alert to patients who had mammograms at Big Sky Diagnostic Imaging in Butte, Montana, about possible problems with the quality of mammograms performed any time after Nov. 19, 2011.

According to the FDA, this "does not mean that the results of the examinations were inaccurate, but it does mean that patients should speak to their healthcare providers about whether their mammograms need to be repeated."

The FDA said the American College of Radiology conducted a routine review of all mammograms performed by Big Sky Diagnostic Imaging taken between Nov. 20, 2011, and Nov. 20, 2013, that found some of the mammograms were of poor quality. The FDA requires that under the Mammography Quality Standards Act (MQSA) all mammography facilities must meet certain quality standards and be certified to legally operate in the U.S. According to the FDA, the facility didn't meet those quality standards. In addition, the ACR has since revoked its accreditation of Big Sky. Alert