Miami-Dade County

FDA orders Miami-Dade medical center to stop mammograms for not meeting federal standards

In a statement to NBC6, the medical center confirmed the mammograms that didn't meet federal requirements happened over the course of two years.

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A medical center in NW Miami-Dade was ordered to stop performing mammograms after the Food and Drug Administration (FDA) discovered that they weren't meeting federal standards.

Affected patients received letters from North Shore Medical Center earlier this year, informing them of the problem and offering to cover the costs for reevaluation.

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In a statement to NBC6, the medical center confirmed the mammograms that didn't meet federal requirements happened over the course of two years.

"In cooperation with the FDA, North Shore Medical Center has contacted patients (and their physicians) who received mammograms over the period from March 14, 2022 to March 14, 2024. Over this time, it was determined that the administration/evaluation of these mammography's were not in line with the industry standard and could be subject to an inaccurate interpretation," the statement read.

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Pembroke Pines resident Liz Guseila-Rizo, both a patient and former employee of the medical center, was one of the women who received the concerning notice.

"I was quite flabbergasted," Guseila-Rizo said. "With a history of breast cancer in my family and me actually being tested and having the gene for it."

She felt especially overwhelmed, since losing her job also affected her personal healthcare.

"What do I do now? I don't have a doctor. I'm in Broward now -- I have to start from scratch," she added. "My insurance has now changed, my doctor's not on it."

She revealed that she was let go from her position -- along with other employees -- after the center's owner, Steward Health Care System, filed for Chapter 11 bankruptcy.

Guselia-Rizo later received the notice that mammograms performed between March 14, 2022 and February 29, 2024 did not meet FDA requirements.

The letter noted that the FDA required the hospital to stop performing mammograms on March 14, 2024. Although mammogram results may not necessarily be incorrect, they may need to be repeated, the letter stated.

"I started calling the numbers listed. It would go to recordings, no one would ever return my call. So, I drove to North Shore to start taking care of it," Guselia-Rizo explained.

She later discovered that one of the phone numbers, listed on the letter, was connected to an employee who had also been let go from the medical center.

Guselia-Rizo is now focusing on finding a specialist to work with, but she has lingering concerns -- including for fears for the women who don't speak English and might not understand the contents of the letter. She also worries for those who don't have medical access because the hospital's Women's Diagnostic Center has since been closed.

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