FDA warns Butte clinic patients that mammograms may be inaccurate
BUTTE, Mont. - Problems at a Butte radiology clinic mean women in Butte might not have gotten accurate mammogram results.
The U.S. Food and Drug Administration said mammograms at a Butte clinic didn't meet quality standards, so they're telling women to get tested again.
Inspectors did a routine review of images taken between November 2011 and November 2013. The report criticizes some of the images' quality.
The FDA just warned Big Sky clinic patients but our time line shows a four-month lapse when the FDA claimed it found problems until the warnings went out to patients.
The clinic's doctor told us thousands of images sent to an FDA-approved radiologist show the mammograms were fine.
Dr. Jesse Cole showed NBC Montana the latest technology in mammography. His clinic can't use their 3-D machine because the American College of Radiology pulled the clinic's accreditation in February. The ACR said the old machine didn't cut it.
"They said one of the features on that didn't work," said Cole. "Which provides automatic breast compression and it that it was unreliable and we should no longer use it, so we immediately quit using it on their instruction."
The ACR asked to review an additional 30 mammograms. Analysts found problems and reported it to the feds.
The FDA warned hundreds of clinic patients that mammograms from the past 2 years were inaccurate. But Cole fought back.
"Our primary concern was to figure out, is there a problem and what is it?" he said.
He said he sent 2,700 tests to an FDA-approved radiologist in North Carolina and that radiologist says only 7 percnet are faulty. Cole wants the FDA to knock the old machine out of circulation.
"I filed the first device complaint on this back in January," said Cole. "And we think it's incumbent on the FDA to see if this machine is obsolete."
Right now, St. James Healthcare is the only health care provider that offers mammograms in Butte, so we asked whether they've seen an increase in patients.
"We have," said St. James Healthcare Vice President of Finance Jay Doyle. "We've seen a drastic number in of increase in patients."
Doyle estimated he's seen 20 percent more patients -- so much that he is considering expanding hours.
Doyle said women who received a letter from the FDA should go to their doctors.
At Big Sky Diagnostic Imaging, Cole has met with at least 100 of his patients, telling them he's got the proof that results are OK.
"I'm personally going in and doing ultra examinations and seeing these patients and talking to them to make sure 'Yes, we care,'" said Cole. "We don't want you to leave here thinking we've left any stone unturned."
The bottom line is there are two vastly different reports and women's health is caught in the middle.