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FDA Alerts Public to Mammography Issues at Big Sky Diagnostic Imaging

Jun 25, 2014

In a Safety Communication issued Monday, the U.S. Food and Drug Administration (FDA) alerted the public to issues with mammograms performed at Big Sky Diagnostic Imaging, LLC located in Butte, Montana. The agency said that it found poor quality mammograms when it performed a routine review of a sample of images taken between November 20, 2011 and November 20, 2013. The review was conducted in collaboration with the American College of Radiology (ACR).

The discovery does not necessarily dictate that the results of the examination were inaccurate, but it does mean that patients should contact their healthcare providers to determine if repeat mammograms are needed, the FDA said.

Mammography is a diagnostic and screening tool used to detect breast cancer. Under federal law, the FDA requires mammography facilities to be certified to legally operate and meet certain basic standards of quality. According to the FDA Safety Communication, Big Sky Diagnostic Imaging failed to meet these standards; on February 6, 2014 the facility stopped conducting mammograms. Its accreditation was revoked by the ACT and its MQSA (Mammography Quality Standards Act) certificate is invalid.

If patients have had a mammogram at the facility after November 19, 2011, the FDA has several recommendations. If another mammogram has been performed at another MQSA-certified facility since then, then patients should follow recommendations from that facility. If not, then patients should talk to their doctors about whether or not another mammogram is needed. If another mammogram is recommended, then the FDA advises that it be done at an MQSA-certified facility (an online database of these facilities is available). Patients can call the National Cancer Institute’s (NCI) information service at 1-800-422-6237 for a listing of MQSA-certified facilities nearby that offer free or low-cost mammograms if it is not covered by health insurance.

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