FDA alerts Mont. mammography patients of possible errors

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The FDA has issued an alert to patients who received a mammogram at Big Sky Diagnostic Imaging in Butte, Mont., after the quality of mammograms at the facility was called into question following a routine review.

Any Big Sky Diagnostic Imaging patient who had a mammogram after Nov. 19, 2011, is affected, though the FDA said the safety alert does not mean that all exams are inaccurate. These patients should speak to their healthcare providers about whether a repeat mammogram is necessary.

A review conducted by the American College of Radiology (ACR) of images taken between Nov. 20, 2011, and Nov. 20, 2013, included poor quality mammograms. As a result of not meeting baseline standards under the Mammography Quality Standards Act (MQSA), the ACR revoked the imaging facility’s accreditation. Its MQSA certificate is no longer valid and the facility stopped performing mammography as of Feb. 6, 2014.

Big Sky Diagnostic Imaging’s owner, Jesse Cole, MD, shot back in the press by claiming the problem lies with the ACR. Cole said the facility was denied an appeal and claimed that while the initial review found fault with up to half of the mammography interpretations, a subsequent FDA reviewer disagreed with only 7 percent of the readings, according to The Montana Standard.