South Florida radiologist has not notified patients about possible problems with their mammograms

(WSVN) - A South Florida radiologist has been ordered to tell his patients about possible problems with their mammograms, but he’s not doing it. Tonight he’s telling 7’s Brian Entin why.

We have been trying to talk to Dr. Kaya Colak, including this time back in January.

Brian Entin: “Sir, we want to ask you about this new statement from the FDA.”

Questions about his closed Deerfield Beach business Radiology Express.

Dr. Kaya Colak: “I’m here to set the record straight.”

Now Dr. Colak says he wants to clear the air about what went on behind the scenes at his imaging center.

Dr. Kaya Colak: “To be honest with you, it was a devastating time.”

Patient looking in window: “Totally dark. They’re not answering the phone either.”

We first started looking into Radiology Express when the office suddenly closed late last year.

Patients showed up unable to get their medical records.

Patient: “I just left it with them to keep my mammogram records.”

Dr. Colak says his business was in financial trouble, and closing for almost two weeks because of Hurricane Irma made the situation worse.

Dr. Kaya Colak: “When you have a business that you can’t pay the bills, what happens is the people quit. We didn’t have the personnel to provide the patients the records at that time. I did the best that I could under very, very difficult circumstances to protect the integrity of the patients’ medical records.”

Dr. Colak says he transferred the medical records to another doctor’s office. And if patients call the Radiology Express phone number, they’ll be transferred and have access to their records. But there’s another issue. The FDA says there may have been problems with the mammograms.

Dr. Helen Barr, FDA: “If you don’t get an adequate amount of breast tissue, you could possibly miss an area where a cancer is.”

In January, the FDA put out a warning to women after an inspection found “serious image quality deficiencies” at Radiology Express.

While the FDA says the mammograms are not necessarily inaccurate, they still required Dr. Colak to notify his patients about possible problems with their mammograms.

He still hasn’t done it.

Dr. Kaya Colak: “It is not a law that has been broken. It is a request that’s done for the benefit of the patients.”

Brian Entin: “But even if it’s not a law, don’t these patients deserve to know that there could be issues with their mammograms performed at your facility?”

Dr. Kaya Colak: “Yes.”

Brian Entin: “And so, are you going to do that?”

Dr. Kaya Colak: “I don’t have the resources personally to do it.”

Dr. Colak says the FDA requires the notifications be made by certified mail, and that would cost thousands of dollars.

Money he says he doesn’t have.

He says he stands by his mammograms.

Dr. Kaya Colak: “I do not believe that a single mammogram was compromised in quality.”

It’s unclear what happens if Dr. Colak fails to notify his former patients.

The FDA says it does not comment on enforcement actions.

FOR MORE INFO:

For former patients of Radiology Express formerly (known as Palm Beach-Broward Medical Imaging Center) who want to obtain their medical records, call (954) 426-3006. The call will be transferred to another facility.

FDA Jan. 3, 2018 warning:
https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm590827.htm

FDA July 26, 2018 update:
https://www.fda.gov/Radiation-EmittingProducts/MammographyQualityStandardsActandProgram/Reports/ucm614956.htm

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