FDA: Possible Problems with Mammography Images from Raleigh-Based Healthcare Facility

FDA: Possible Problems with Mammography Images from Raleigh-Based Healthcare Facility
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March 24, 2015

A Raleigh-based healthcare practice had its accreditation revoked because of problems with the quality of its mammograms, says the U.S. Food and Drug Administration (FDA).

The FDA is alerting North Carolina patients who had the procedure at Richard D. Adelman Family Medicine any time after August 24, 2012 to have their mammograms reviewed, and possibly redone, by a certified facility.

The American College of Radiology (ACR) did a review of mammograms performed by the practice between August 25, 2012 and August 25, 2014 and identified problems with the quality of the mammograms. ACR revoked the facility's accreditation on November 5, 2014.

On Nov. 18, 2014, the FDA required the facility to notify all patients who received mammograms any time after August 24, 2012 about these problems, and to stop performing mammography.

The FDA said that 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.

If you have had a more recent mammogram at an MQSA-certified facility since then, you should follow the recommendations from that facility.

If you have not had a mammogram at an MQSA-certified facility since then, follow these guidelines, consider requesting your mammogram and copies of your medical reports and have your mammogram reviewed at an MQSA-certified facility to determine whether a repeat mammogram or additional medical follow-up is needed.

A database of MQSA-certified facilities in your area is available online or by calling the National Cancer Institute's (NCI) information number at 1-800-422-6237.

If you need a repeat mammogram and your health insurance will not pay for it, you can call the NCI information service at 1-800-422-6237 for a listing of MQSA-certified facilities near you that provide free or low-cost mammograms.

For questions or more information, contact the MQSA Hotline at 1-800-838-7715, email MQSAhotline@hcmsllc.com or fax 1-410-290-6351.