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FDA Notifies Patients of Mammography Problems at Ecumed Health Group Facility in Hialeah, Florida

The Food and Drug Administration (FDA) today is alerting patients about possible problems associated with the quality of mammograms performed at the Ecumed Health Group facility in Hialeah, Fla., over recent years. The facility is located at 687 East 9Th Street.

Women affected by this alert are those who had mammograms at this facility from January 7, 2001, to the present. The facility is no longer performing mammography.

FDA has worked closely with Florida’s Bureau of Radiation Control to inspect the facility and develop information about the nature and extent of the problems there. As a result, Florida withdrew the facility’s authorization to use the mammography unit and fined the facility for operating the unit without proper state authorization. FDA is also pursuing fines against the facility.

FDA’s review of a sample of mammography examinations done by the Ecumed Health Group facility showed that the mammograms were of poor quality and not reliable and the facility did not meet the standards for clinical image quality as required by the FDA. Under the Mammography Quality Standards Act (MQSA) of 1992, the FDA’s role is to ensure that all mammography facilities meet certain high quality standards.

While this information does not necessarily mean that the results of all of the examinations were inaccurate, it does mean that patients might need to have mammograms re-evaluated and possibly repeated.

FDA has contacted all physicians’ offices known by the agency to have sent mammography patients to the Ecumed Health Group facility and informed them of the problem. Physicians who have not been contacted by FDA but believe that one or more of their patients had a mammogram at this facility during the time period in question can contact Ecumed for further patient information.

FDA is providing the following advice for patients.Patients who have had a mammogram at another facility since the one taken at Ecumed Health Group should be advised that they do not need to take any action other than to follow the recommendations from the subsequent mammogram.

Patients who had a mammogram at Ecumed Health Group any time after January 7, 2001, and have not had a mammogram at another facility since then, should have their mammogram re-evaluated or repeated. These patients should observe the following guidelines:

• Talk with your doctor as soon as possible about medical follow up.
• If you have a different doctor than the one who referred you to Ecumed Health Group, you should talk to your new doctor as soon as possible.
• Call Ecumed Health Group to arrange for your mammography exam report and x-rays to be given to you.
• If your doctor wants you to have the mammogram repeated it should be done at an MQSA-certified facility. Your doctor may recommend a facility, or you can find a list of MQSA-certified facilities at http://www.fda.gov/CDRH/MAMMOGRAPHY/certified.html
• If you need to schedule a repeat mammogram and your health insurance will not pay for it, you can call the National Cancer Institute’s (NCI) information number at 1-800-422-6237. Experts at this number can tell you if there is a facility near you that provides free or low cost mammograms. These experts can also answer questions about breast health and mammograms.

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