FDA notifies patients of mammo problems at Florida facility

The FDA is issuing a notification for patients who received a mammogram at Med Pro Imaging in Plantation, Fla. between May 21, 2008 and Sept. 30, 2009, after the agency became aware of problems associated with mammogram quality at the facility.

A sample of mammograms performed by Med Pro Imaging that included images taken during the aforementioned timeframe were reviewed by the FDA and the American College of Radiology, and deemed “poor quality” with “unreliable results,” according to the Mammography Quality Standards Act (MQSA) of 1992.

As a result, the agency is now alerting healthcare providers who have referred patients to the Med Pro Imaging facility for a mammogram between May 21, 2008 and Sept. 30, 2009, as well as recommending that patients have their mammograms re-evaluated and possibly repeated.

For patients who underwent mammography at the facility during this time, the FDA has also issued the following recommendations:

•    Patients who have had a mammogram at another facility since then should follow the recommendations from the latest mammogram.
•    Patients who have not had a mammogram at another facility since then should talk with a healthcare provider as soon as possible about a medical follow-up.
•    Repeat mammograms should be performed at an MQSA-certified facility to ensure quality and accuracy.

Currently, Med Pro is under new management and is operating as Rivero Diagnostic Center.