FDA Issues Alert on Mammography Quality Problems at North Carolina Facility

April 2, 2015 — The U.S. Food and Drug Administration (FDA) is alerting patients who had mammograms at Richard D. Adelman, M.D., Family Medicine in Raleigh, North Carolina, about possible problems with the quality of their mammograms. The alert applies to patients who had mammograms any time after Aug. 24, 2012.

The American College of Radiology (ACR) did a review of mammograms performed by the practice between Aug. 25, 2012, and Aug. 25, 2014 and identified problems with the quality of the mammograms. ACR revoked the facility’s accreditation on Nov. 5, 2014. On Nov. 18, the FDA required the facility to notify all patients who received mammograms at its facility any time after Aug. 24, 2012, about these problems, and to stop performing mammography.

This does not necessarily mean that the results of the mammograms were inaccurate, but patients should have their mammograms reviewed at a Mammography Quality Standards Act (MQSA)-certified facility to determine if they need a repeat mammogram or additional medical follow-up. Patients have the right to request their original mammogram and copies of their medical reports from Richard D. Adelman, M.D., Family Medicine practice. 

For more information: www.fda.gov