FDA issues warning about Puerto Rican mammo facility

The U.S. Food and Drug Administration (FDA) has issued a warning to patients who had mammograms at a breast imaging facility in Puerto Rico.

The warning concerns possible problems with the quality of mammograms performed at San Sebastian X-Ray in San Sebastian, Puerto Rico, any time after February 27, 2011, according to the FDA. The agency worked with the American College of Radiology (ACR) during San Sebastian's accreditation renewal; a sampling of mammograms performed at the facility between February 27, 2011, and February 27, 2013, included poor-quality exams.

"This does not mean that the results of the examinations were inaccurate, but it does mean that patients need to have their tests re-evaluated and should speak to their healthcare providers about whether their tests need to be repeated," the agency said.

San Sebastian X-Ray no longer performs mammography due to a denial of its accreditation by the ACR and the expiration of its Mammography Quality Standards Act (MQSA) certification by the FDA.