In the last month, the I-Team reported the stories of three women who say a local imaging center missed their breast cancer. That clinic was ordered by the FDA to stop performing mammograms altogether this summer.While the accounts of breast cancer patients shared with 5 On Your Side are connected to a single facility, what they experienced has the potential to happen anywhere. Experts estimate that, even under the best conditions, a mammogram can be only 80 percent effective in detecting breast cancer.STORY: https://www.ksdk.com/article/news/investigations/breast-health-expert-advice-fda-mammography-action/63-0263d968-159d-4577-88b0-24d3b2b7f580“There are, unfortunately, scenarios where it’s not just that the cancer is missed, but that it can’t be seen on the mammogram,” said Dr. Debbie Bennett, chief of breast imaging at Washington University in St. Louis. “One of the most common scenarios is in women that have very dense breast tissue.”Mammogram technology has advanced in recent years, and upgraded equipment can make a big difference, Bennett added.“We always advise patients that they should have a 3-D mammogram. It’s more accurate than a 2-D mammogram,” she said. “It essentially gives you a look through each individual layer of the breast tissue. So, there have been a lot of studies looking at whether 3-D mammography performs better than 2D mammography does, and most of the data show that you can find more cancers with the 3-D mammogram, but also that there are fewer false positives. So fewer cases where we’re asking a woman to come back for more pictures and then telling her that it’s fine, ultimately.”Experts tell the I-Team that the type of action the FDA took at Watson Imaging Center, where the three breast cancer patients got their mammograms, is rare. The order to cease conducting mammograms followed an audit by the American College of Radiology, which uncovered “image quality” issues.“What they’ll do is ask for a random sample of patient mammograms on a specific day, and they just pick a random day and they ask for you to send them in. And then an expert at the ACR looks at them and decides whether they do, in fact, meet standards,” said Bennett.The time frame for an ACR audit of mammograms or action from the FDA is usually recent, and Bennett says that for at least one of the patients who reached out to the I-Team, her mammogram occurred too long ago for the FDA to take action.Bennett advises people to go to a specialized breast center for mammogram needs.“In most instances, if somebody is feeling a lump, we would do both the mammogram and the ultrasound,” said Bennett. “Breast ultrasound is an entirely different test from a mammogram that doesn’t have the same issues with breast density that a mammogram might. And so, we would look with ultrasound specifically at the area that the patient’s complaining about.”ACR reviews at mammography providers generally occur every three years, with their accreditation cycle. There is a possibility for additional spot-checks on a more frequent schedule. The ACR declined to tell the I-Team what initiated the review at Watson Imaging Center. In addition to audits from the ACR, all imaging clinics are inspected by the State of Missouri at least once a year.
Watson Imaging Center was told by the FDA to stop giving mammograms after 3 local women’s breast cancer was missed. Experts say it could be missed at any facility.
Years before the FDA ordered a south city facility to stop performing mammograms, these women say their screenings missed advanced cancers.
Years before the Food and Drug Administration ordered a south city facility to stop performing mammograms, these women say their screenings missed advanced cancers.
This summer, thousands of patients who received mammograms at Watson Imaging Center in South City found out that quality issues have called years of screenings into question. An inspection conducted by the American College of Radiology resulted in more than two years of mammogram results being invalidated. When the I-Team reported on FDA action at the center, viewers reached out with concerns that even more people could be affected.One of those former patients from Watson Imaging Center is Sharon Munden. She has a family history of breast cancer, so when she found a lump and noticed inflammation on her breast in May 2018, she knew a mammogram was in order.“I have a maternal aunt who has had multiple recurrences of breast cancer,” said Munden. “My mom actually was diagnosed.”In 2011, Jane Thomson said she had many of the same symptoms. “The night that I felt the lump on my breast, it was a Friday night and I started calling right away,” she told the I-Team.Their first step was a mammogram at Watson Imaging Center. Another thing Munden and Thomson share was that they wanted the screening staff to see exactly why they were concerned.“Something was wrong, something was there,” remembered Thomson. “I told them where the lump was and [the staff member] felt it.”“I mentioned my symptoms to her and she made a note of it, and actually commented on the fact that she could see the visual symptoms as well. So I was feeling pretty confident that they were going to take my experience seriously,” said Munden. “It was after that, that my opinion changed pretty dramatically.””A false sense of security”Looking back, they both say that their choice of screening provider could have cost them their lives. That’s because Watson sent both women letters from doctors that stated their mammograms showed “no evidence of cancer.”“It is a sense of relief and it’s like the worst that could possibly happen, isn’t happening,” said Munden. Her relief wouldn’t last long. “Within a week and a half of the scan itself,” she adds, “I got my cancer diagnosis.” Munden’s cancer was already past the early stages.Thomson shares this in common with Munden as well. The bad news from her second opinion came eight days after her screening at Watson: “She called me on March 16, 2011, said I had breast cancer.”When her doctor detected cancer, it was already in stage three, meaning that it had begun to spread.Thomson even followed up with Watson after that news. “I called the doctor. He said they should have done a biopsy that day,” she recalled.Dr. Greg Cizek, who signed off on Thomson’s scan, told the I-Team that he only filled in at Watson Imaging when they were short-staffed. While he didn’t remember Thomson’s case, he said nearly 20 percent of all cancers are not seen on a mammogram.Medical Records show what Watson missedThe I-Team compared the reports from Watson to reports from Thomson and Munden’s second opinions.Watson’s radiology reports stated Thomson’s mammograms showed “no malignant mass.” Just days later, her doctor wrote, “There is an easily palpable mass in the left breast,” and expressed concern that her first mammogram “did not show any findings, as [the mass] is quite prominent.”Records show, Watson didn’t refer Thomson nor Munden for follow-up testing, despite both women complaining of lumps and breast inflammation. the presence of a lump and breast inflammation.Munden informed Watson of her diagnosis as well, in a letter, and got a reply from practice manager Denice Loving, who wrote that “The reading radiologist did make note on the report that you had symptomatic firmness in your left breast and carefully reviewed the 2-D images.” The radiologist concluded that the images fell into Category 1, “which requires no immediate follow-up.”Loving’s letter also mentions that on August 28th, 2018, months after Munden’s mammogram, the facility upgraded to 3-D Tomosynthesis imaging.When the I-Team talked to Watson’s practice manager, Denice Loving, she told 5 On Your Side’s PJ Randhawa that the center had received no reports of mammograms that missed cancer.“I wish they would have talked to me about the need for a diagnostic mammogram. I wish that my results would have been, not negative, but inconclusive,” said Munden. “I asked them to review other patient files in case there were circumstances like mine that a diagnosis might have been missed.”The FDA takes actionA review of Watson’s past mammograms would eventually happen in 2021, conducted by the American College of Radiology and surveying dozens of reports going back to 2019.The result was that the FDA forced Watson to stop performing mammograms immediately due to “image quality” issues.The three women who spoke with 5 On Your Side about cancer diagnoses they say were delayed by a mammogram at Watson never received a letter about their results, because the ACR review didn’t extend that far.
A viewer reached out to 5 On Your Side after receiving an alarming letter about the facility she relied on for her annual mammograms.