FDA Shuts Down Mammogram Services at a Miami Radiology Clinic

A well established radiology center in Miami is under scrutiny for the quality of their mammogram services performed between May 16, 2016 and April 9, 2018.

The Food and Drug Administration (FDA) demanded Lakes Radiology II stop performing mammograms and send out letters to patients who had received mammograms over that two-year time period. According to NBC, the imaging clinic had failed to meet the Mammography Quality Standards Act (MQSA), and the FDA rejected the center’s accreditation due to “technical problems.”

The FDA regularly inspects mammography imaging clinics to make sure they’re meeting MQSA criteria. Physicians are evaluated to make sure that they can accurately interpret mammograms and effectively perform the procedure. Patients are recommended to only go to facilities where the physicians who read mammograms are subspecialized in mammography and spend at least 50 percent of the time evaluating breast images.

Monica Yepes, MD, a radiologist who specializes in breast imaging at the University of Miami Health System, suggested that patients choose a facility that provides a variety of female-directed modalities such ultrasound, MRI, and biopsies.

Lakes Radiology has stated that they are “working very closely with the FDA to correct all issues…" and "… are expecting to finish the process in the upcoming weeks so we can reopen the mammography department to the public."