FDA Warns of Poor Quality Mammograms from Florida Lab

Federal regulators have issued a warning regarding poor quality mammograms at Medisound, Inc., a Florida testing facility, saying that anyone who was tested there may want to be re-tested elsewhere. 

The FDA safety notification was issued on August 27 to patients who had mammograms done at Medisound, Inc. in Kissimmee, Florida, and to health care providers who referred patients there. The FDA warned that investigators have become aware of problems with the quality of mammograms performed at the laboratory, which could potentially cause a breast cancer misdiagnosis.

Mammograms are low-dose X-ray images made of the breast. They are used to detect the early stages of breast cancer.

The FDA and the American College of Radiology (ACR) were reviewing mammograms from the facility when they discovered poor quality mammograms that possibly generated unreliable results. The mammograms in question were taken between June 10, 2008 and June 10, 2010.

Medisound, Inc.’s mammograms failed to meet the required standards under the Mammography Quality Standard’s Act (MQSA) of 1992, according to federal regulators. Medisound subsequently lost its ACR accreditation and no longer performs mammograms.

The FDA is advising any patients who had a mammogram performed at Medisound to talk to their healthcare provider about possibly getting re-tested. Anyone who has had a mammogram at another facility since then should rely on that test’s results, and not the results of the Medisound mammography.

Former Medisound patients can get copies of their mammograms by calling 407-610-1894. Patients whose health insurance will not pay for a repeat mammography can call the National Cancer Institute at 1-800-422-6237 for a list of free or low-cost facilities that perform mammograms.