About 12,000 mammograms taken at a Hilo medical facility over the last two years may not be accurate.
The U.S. Food and Drug Administration has pulled the Hilo Women's Imaging Center's mammogram certification after one of its two machines failed to meet standards.
The questionable mammograms were taken between June 2014 and August 2015.
Officials with Hawaii Radiologic Associates, which operates Hilo Women's Imaging Center, say there may have been errors with the mammogram images, but they don't believe any misdiagnoses occurred as a result of the faulty machine.
Hilo obstetrician and gynecologist Dr. Frederick Nitta says about 300 of his patients are affected.
"Some patients are in a panic because they are getting letters from Hilo Radiology regarding questions of whether their mammogram was adequate, whether the machine was working well or whether the mammograms were misread," Nitta said.
However, Nitta says he is not worried.
He's meeting with each patient to assess their risk and to determine whether they can wait for their next scheduled appointment or if they need to get in sooner.
"I've been here for 23 years and I have never ever seen them miss a breast cancer yet. Talking to all the other doctors they've said the same thing: they have never missed anything that they've ever seen. We have confidence that the mammograms were being read properly," Nitta said.
Mammograms are proven to reduce the risk of women dying from breast cancer and the American Cancer Society says early detection is key.
"ACS recommends starting mammograms beginning at age 45 and annually from 45 to 55 and from age 55 every two years," said Dr. Jared Acoba, an oncologist and assistant researcher at the University of Hawaii's Cancer Center.
Dr. James Lambeth, president of Hawaii Radiologic Associates, released the following statement:
"Patients who had mammography at our Hilo center during that time should not take this lightly. Those who receive our letter should contact their doctors immediately to review their exam and determine if a repeat exam is warranted. We apologize for this apparent lapse in quality assurance at our Hilo Center. We want to make very clear that our Kona facility is unaffected by the decertification."
Upon request from patients, officials say HRA will review all mammograms taken during the time in question and when necessary perform another mammogram for free at their Kona facility.