(WSVN) - Could some women have breast cancer and not know it after getting a clear mammogram? That possibility has the FDA warning patients at one South Florida doctor’s office. 7’s Brian Entin investigates in our special report, “Worry for Women.”
Brian Entin: “Sir, we want to ask you about this new statement from the FDA.”
We tried to talk to Dr. Kaya Colak about questionable mammograms done at his Deerfield Beach office after the Food and Drug Administration issued a warning to women.
Dr. Helen Barr, U.S. Food & Drug Administration: “At the yearly inspection of this facility, there were multiple inspection violations.”
This is the FDA doctor in charge of mammogram quality nationwide.
Dr. Helen Barr says there were problems with the way women were positioned on the X-ray machines at Palm Beach-Broward Medical Imaging Center. The office was later renamed Radiology Express, but still owned by Dr. Colak.
Dr. Helen Barr: “If you don’t get an adequate amount of breast tissue, you could possibly miss an area where a cancer is.”
The FDA says the bigger issue is “…the facility has not performed the ordered notification” to patients about possible problems with their mammograms.
Former patients like Dianne and Rosalyn are concerned.
Dianne Weaver, former patient: “It’s a big deal, because mammograms are the number one tool to detect breast cancer. Of course it’s a big deal for women.”
Rosalyn Cogan, former patient: “That is terrible. That is so terrible. Because when I was there, I went several times. I met the doctor!”
7News has been looking into the facility since last year, when Radiology Express abruptly closed.
Dianne Weaver: “Totally dark. They are not answering the phone, either.”
Patients couldn’t get their medical records.
And we found a Broward Sheriff’s Deputy at Dr. Colak’s office after the bank foreclosed on the property.
Brian Entin: “Can you look at this?”
Dr. Colak didn’t want to talk to me. But he later called and said he’s in contact with the FDA and doing everything to rectify the situation.
Dianne Weaver: “As women, and all women, we should not have to worry whether we’re getting the best health care.”
Dianne and Rosalyn got mammograms at new offices, and they’re cancer-free.
But they worry for other patients.
Rosalyn Cogan: “I think it is terrible and dangerous for all the people who had their X-rays there, because they could be walking around with all kinds of diseases and problems and they think they are safe.”
Although the FDA stresses the mammograms are not necessarily inaccurate, they are urging women who had a mammogram here after April 2, 2016 to talk to their doctor about the possibility of getting a new mammogram.
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