FDA Alerts North Carolina Patients about Possibly Inaccurate Mammograms
The Food and Drug Administration (FDA) has warned that mammograms performed at a family medicine practice in Raleigh, North Carolina after August 24, 2012 may have experienced quality issues. A low-quality mammogram may result in a late or misdiagnosis of breast cancer.
According to the Safety Communication issued by the FDA on March 24, 2015, quality issues may exist with mammograms performed at the Richard D. Adelman, M.D., Family Medicine practice in Raleigh, North Carolina after August 24, 2012. The American College of Radiology (ACR) discovered problems with the quality of mammograms following a review of images performed there between August 25, 2012 and August 25, 2014. ACR revoked the facility’s accreditation on November 5, 2014. On November 18, the FDA ordered the practice to cease performing mammograms and to inform all affected patients of the situation.
A mammogram is a low-dose X-ray image of the breast. The FDA says a mammogram is the most effective screening method for detecting breast cancer in its earliest, most treatable stages.
In the safety alert, the FDA explained that the situation with the Adelman facility does not necessarily mean that the results of the mammograms were inaccurate, but patients should have their mammograms reviewed at a facility certified under the Mammography Quality Standards Act (MQSA) 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.
The FDA, under the Mammography Quality Standards Act (MQSA) of 1992, requires that all mammography facilities meet certain baseline quality standards and be certified to legally operate in the United States. The North Carolina facility did not meet standards for mammography quality under the act. Because its accreditation has been revoked, the facility may not perform mammography until the accreditation is reinstated.
The FDA made a number of recommendations for patients who had a mammogram at Richard D. Adelman M.D., Family Medicine practice any time after August 24, 2012. A patient who has not had a mammogram at an MQSA-certified facility since then should consider requesting the mammogram and copies of medical reports from Richard D. Adelman, M.D, Family Medicine practice and have the 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 is available online or by calling the National Cancer Institute’s (NCI) information number at 1-800-422-6237.
A patient who needs a repeat mammogram and whose health insurance will not pay for it can call the National Cancer Institute information service at 1-800-422-6237 for a listing of MQSA-certified facilities near you that provide free or low-cost mammograms. Any patient, who has had a more recent mammogram at an MQSA-certified facility since then, should follow the recommendations from that facility.
Read more: Mammogram Accuracy Depends On Physician
