The Food and Drug Administration has stopped a radiology center in Sunrise from performing more mammograms until they correct a problem.
The FDA ordered Lakes Radiology II on Oakland Park Boulevard to send letters to patients who had mammograms there between mid-2016 through April of this year.
In those letters, the center states, "there is a serious concern about the quality of mammography that our facility performed between May 16, 2016 and April 9, 2018."
As a result, the FDA ordered it to stop performing mammograms as of April 19 because it "did not meet the clinical image quality standards established by our facility's accreditation body."
The owner of Lakes Radiology II declined requests from NBC 6 Responds for an interview but via email told us the problem started in April when the center tried to add a second mammography machine and the FDA denied it accreditation due to technical problems. It's based on what's called the Mammography Quality Standards Act or MQSA.
"It's something that Congress came up with in the 1990's to make sure that facilities that practice mammography do it under a certain quality standard," said Dr. Monica Yepes, head of radiology at the University of Miami's Sylvester Comprehensive Cancer Center. "So, what happens is we get tested regularly to make sure we are meeting those standards."
Dr. Yepes couldn't talk specifically about the Lakes Radiology II case, but explained all centers are checked to make sure physicians are qualified to read mammograms and that the exams are performed correctly.
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"Are we radiating the patients adequately? Not over-radiating them or under-radiating them because either way we might be missing information or hurting the patient if there's too much radiation," said Dr. Yepes.
The center states that the letters don't necessarily mean that test results are wrong but that most patients will need to have their mammograms reviewed to determine if a repeat mammogram is needed.
Dr. Yepes recommended that patients who get a letter should request their records - including the report and CD images.
"If your last mammogram was over a year ago, just start by getting an appointment at another facility and what you can do is take your images and use it for comparisons," said Dr. Yepes. "If your mammogram was less than a year ago, then the idea would be to have your studies reviewed at a facility that is accredited."
An accredited center must have a certificate with something called an American College of Radiology (ACR) seal. The doctor recommends patients also ask if the radiologists who interpret mammograms have a subspecialty in breast imaging and that they go to a center where radiologists spend at least half their time interpreting breast imaging.
"Other things to look at is the facility where you are having your breast imaging a facility that also offers the other modalities in addition to mammography such as ultrasound and MRI and do they also do biopsies," said Dr. Yepes.
Lakes Radiology II offered those services in the past but since they lost accreditation they say they are "working very closely with the FDA to correct all issues…" and "… are expecting to finish the process in the upcoming weeks so we can re-open the mammography department to the public."
The center also says it will provide patients their records at no charge.
Also, recently, the FDA revoked the accreditation of another center in Deerfield Beach because they failed to send the required letters to patients.
Lakes Radiology has another center in Miami Lakes that has no problems and still offers mammography, ultrasounds and MRIs.
Experts recommend women should get mammograms annually starting at age 40 as long as they are at normal risk for breast cancer.
