Medical professionals have debated the frequency and relative age for performing mammogram studies on women; some claiming that once yearly is too often and under 50 years old is too soon. Whether these debates involve more concern for insurance company payouts than prudent healthcare, I will leave to other articles.
Mammography patients in South Florida received some troubling news today, which could place patients at serious risk.
The Food and Drug Administration (FDA) issued a Safety Communication warning consumers about possible quality problems with mammograms performed at the Palm Beach Broward Medical Imaging Center located in Deerfield Beach, Florida. The warning involves mammograms done on or after April 2, 2016. The FDA is cautioning patients who received mammograms at the facility they may want to be re-evaluated after information surfaced indicating there may have been problems with the quality of the mammograms. The issue seems to be whether the mammogram scans were of sufficient quality to allow a precise reading and competent interpretation of them.
A mammogram is a safe form of x-ray imaging that is commonly used to detect breast cancer and, hopefully, allow for early detection and treatment. Women between 45 and 54 should have yearly mammograms. The National Cancer Institute reports that:
“Randomized controlled trials (RCTs) initiated 50 years ago provide evidence that screening mammography improves breast cancer survival for women aged 60 to 69 years (solid evidence) and women aged 50 to 59 years (fair evidence). Population-based studies done more recently raise questions as to the benefits to screened populations who participate in screening for longer time periods.”
Early detection of breast cancer allows for the most successful treatment options and outcomes, which is why the FDA monitors the quality of radiology studies such as mammography. As important as discovering early on-set breast cancer, it is just as important to not improperly diagnose patients with breast cancer who do not actually have it. The quality of mammography studies is just as important in avoiding treating patients for a non-existent disease diagnosis.
According to the FDA, the Palm Beach Broward Medical Imaging Center located in Deerfield Beach, failed to perform quality control tests which were recommended by the mammogram equipment manufacturer. The American College of Radiology (ACR) ultimately performed a review of mammograms performed by Palm Beach Broward Medical Imaging Center and determined that the imaging did not meet the ACR’s clinical image evaluation criteria. In November of 2017, the ACR revoked the facility’s accreditation. The facility is currently prohibited from performing any further mammogram imaging:
“The results of an annual MQSA inspection of this facility in February 2017 indicated that the manufacturer’s recommended quality control tests were not performed after April 1, 2016. As a result, the FDA notified the facility that it was required to undergo an Additional Mammography Review (AMR) to determine if the overall quality of mammography performed at the facility was compromised due to the failure of the facility to operate in compliance with the MQSA.
The American College of Radiology (ACR) conducted a AMR of mammograms performed by Palm Beach Broward Medial Imaging Center and results indicated the mammograms did not meet the ACR’s clinical image evaluation criteria. On November 9, 2017, the ACR revoked the facility’s accreditation and on November 14, 2017, the FDA placed the facility’s MQSA certificate in a ‘no longer in effect’ status.”
The Mammography Quality Standards Act of 1992 (MQSA; amended in 1998 and 2004) helps to ensure the safe, reliable detection of breast cancer through setting standards for mammography facilities in the United States. If the equipment used to perform the breast mammograms is defective, it can make the reading and interpretation of the scans more difficult for the reading radiologists. If signs of cancer are missed, it can mean the difference between life and death for some patients.
Patients who received a mammogram at the facility on or after April 2, 2016 are encouraged to speak with their health care provider to determine whether additional medical care is necessary.