August 25, 2010 - The U.S. Food and Drug Administration (FDA) is working with the American College of Radiology as they initiate a review of a sample of mammograms performed by a Florida clinic suspected of inaccurate radiological reviews.
The review of the Med Pro Imaging facility in Plantation, Fla., includes images taken between May 21, 2008 and Sept. 30, 2009. Results from that review included poor quality mammograms with unreliable results. Under the Mammography Quality Standards Act (MQSA) of 1992, the FDA requires that all mammography facilities meet certain high quality standards, which the facility did not meet.
The FDA is alerting patients who had mammograms at this facility between the dates in question about possible problems with the quality of mammograms performed. This does not mean the results of all of the examinations were inaccurate. It does mean that patients might need to have their mammograms re-evaluated and possibly repeated.
Med Pro is under new management and is now operating as Rivero Diagnostic Center, located at the same address, the FDA said.
For more information: www.fda.gov