FDA Warning for Mammograms at Montana Clinic

FDA Warning for Mammograms at Montana ClinicJune 23, 2014 — The U.S. Food and Drug Administration (FDA) is warning about the quality of mammograms performed at Big Sky Diagnostic Imaging, LLC, located in Butte, Montana.

The FDA became aware of problems during a routine review of a sample of mammograms, including images taken between November 20, 2011 and November 20, 2013. The images were reviewed in conjunction with the American College of Radiology (ACR). According to the FDA:

“Results from that review included poor quality mammograms. .. 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.”

Federal law requires certain baseline quality standards for all mammography facilities. As of February 6, 2014, Big Sky Diagnostic Imaging is no longer performing mammograms.

The FDA recommends that patients who had a mammogram at this clinic after November 19, 2011 should talk to their health-care provider about the need for a follow-up exam. If you need another mammogram, schedule one at a MQSA-certified facility.

Early detection of cancer is important. Unfortunately, about 40% of women have dense breast tissue that is very difficult to read on a mammogram. Tumors show up white on mammograms, but so does fibrous connective tissue. Mammograms often miss breast cancer in women with dense breast tissue until the cancer is larger and more difficult to treat.

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