FDA Warns Patients of Florida Clinic about Potentially Faulty Mammograms

FDA Warns Patients of Florida Clinic about Potentially Faulty Mammograms
August 17, 2015

The U.S. Food and Drug Administration (FDA) is warning patients who had mammograms at Boston Diagnostic Imaging that their test may not have been properly executed.

The announcement comes after the American College of Radiology (ACR) conducted a clinical image review of mammograms performed by the Orlando-based practice between May 13, 2013, and May 13, 2015. The review was conducted after deficiencies were noted in the clinical cases that were submitted with the facility's accreditation renewal application. The FDA suspended the facility's Mammography Quality Standards Act (MQSA) certificate on Aug. 13, 2015, and directed the facility to cease performing mammography.

The FDA will be notifying all patients who received mammograms at the facility. The agency urges patients to consider having their mammograms re-evaluated at a MQSA-certified facility to determine if the patients need a repeat mammogram or additional medical follow-up.

If your most recent mammogram was performed by Boston Diagnostic Imaging, the FDA recommends taking the following steps:

  • Talk with your health care provider as soon as possible about your medical follow-up. You may need your mammogram re-evaluated, and possibly need a repeat mammogram and/or possible further evaluation.
  • If your health care provider recommends a repeat mammogram, it should be done at an MQSA-certified facility to ensure quality and accuracy. A database of MQSA-certified facilities in your area is available online or by calling the National Cancer Institute's (NCI) information number at (800) 422-6237.
  • If you need a repeat mammogram and your health insurance will not pay for it, you can call the NCI. Experts at this number may be able to identify a facility near you that provides free or low-cost mammogram.