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North Carolina Patients Receive FDA Alert about Possibly Inaccurate Mammograms

Apr 2, 2015

Mammograms performed at a family medicine practice in Raleigh, North Carolina after August 24, 2012 may have quality issues and the Food and Drug Administration (FDA) has taken action to inform affected patients and stop mammograms at the facility until the facility is in compliance with standards.

A low-quality mammogram may result in late or misdiagnosis of breast cancer, which may affect the patient’s treatment and prospects for long-term survival. According to the Safety Communication the FDA issued on March 24, 2015, quality issues may exist for mammograms performed at the Richard D. Adelman, M.D., Family Medicine practice in Raleigh, North Carolina after August 24, 2012. In a review of images done at the Adelman facility between August 25, 2012 and August 25, 2014, the American College of Radiology (ACR) discovered problems. 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, and, according to the FDA, is the most effective screening method for detecting breast cancer in its earliest, most treatable stages.

The FDA explained in the safety alert that not all mammograms from the Adelman facility in that time period are inaccurate, but it is important for patients to 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. Under MQSA, patients have the right to request their original mammogram and copies of their medical reports from Richard D. Adelman, M.D, Family Medicine practice.

Under the 1992 Mammography Quality Standards Act (MQSA), the FDA requires all mammography facilities to 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 Because its accreditation has been revoked, the facility may not perform mammography until the accreditation is reinstated.

In the safety communication, 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. If the patient has not had a mammogram at an MQSA-certified facility since the one at the Adelman facility, the patient 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. Patients who are now due for a mammogram should choose an MQSA-certified imaging facility. A database of 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 accredited facilities that provide free or low-cost mammograms. Any patient, who has had a mammogram at an MQSA-certified facility since the one at the Adelman practice, should follow the recommendations from that facility.

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