FDA warns of mammo problems at defunct Fla. imaging center

by Brendon Nafziger, DOTmed News Associate Editor | August 20, 2010
FDA warns of
"unreliable" mammograms.
The U.S. Food and Drug Administration warned patients who had a mammogram at a defunct Florida imaging center that they might need to get another exam.

The FDA said Tuesday that patients who got mammos at Med Pro Imaging in Plantation, Florida between May 21, 2008 and Sept. 30, 2009 should talk with their doctors about possibly getting a follow-up exam.

The FDA said it worked with the American College of Radiology to review a sample of the exams and discovered some were "poor quality mammograms with unreliable results." DOTmed News is awaiting comment from the FDA about what exactly was wrong with the exams.

The FDA added that the notice doesn't mean all mammograms performed at the facility were inaccurate or needed to be repeated. But to be safe, patients should still consult with their doctors, and also try to retrieve copies of their old exams, either from the imaging center's new owners or from Iron Mountain, if they've been archived.

The original imaging center no longer exists. Its office space and some of the equipment were bought by Rivero Diagnostic Center, an imaging group based in Hialeah, Fla., in Sept. 2009, according to the group.

The group's director told DOTmed News it wanted the space for its second location because the address had been associated with imaging for almost three decades. But the group said it also bought a new mammogram unit.

The FDA polices mammography centers under the Mammography Quality Standards Act of 1992. According to the agency's most recent figures for August, 80 percent of certified and accredited facilities had no violations this year. When the agency began inspections in the late 1990s, only a third of facilities were violation-free, according to information provided on the FDA's website.