Hank Investigates: Could Your Mammogram be Wrong?

Sandra Ferguson
"I was very happy."

She got the results she'd hoped for.

Sandra Ferguson
"There was no problems. No cancer."

But then, a frightening announcement. Officials shut down her mammography clinic, calling the x-rays unreliable.

Dr. Antonia Novello, New York Health Commissioner
"The filming was wrong, the positioning was wrong, the machine was wrong."

Sandra instantly got a new x-ray at a different facility, but this time her doctors had a new diagnosis. She had cancer.

Sandra Ferguson
"I thought I was going to die."

Could your mammogram results be wrong? Our investigation found Massachusetts clinics failing federal and state standards hundreds of times.

Inspection results we obtained reveal:

• Nine out of ten facilities with more than one violation
• One in four facilities with serious and repeat violations

Hank Phillippi Ryan
"If you saw a facility that had violations, would you want to go there?"

Dr. Suzanne Parisian, Former FDA Chief Medical Officer
"No, I wouldn't go there."

Dr. Suzanne Parisian is a former chief medical officer at the U.S. Food and Drug Administration, the same agency that oversees the annual inspections.

Dr. Suzanne Parisian, Former FDA Chief Medical Officer
"If the test isn’t well-run or of good quality, it can’t come up with quality results."

And documents we examined reveal uncalibrated x-ray machines, unqualified employees, failure of quality control tests, improper record keeping, and even falsified documents.

Of the almost 200 facilities inspectors checked in Massachusetts, only six have no violations. What’s more, the records we found reveal failures at facilities across the country. FDA officials refused an on camera interview, but told us, "violations cited in inspection reports do not necessarily rise to the level of seriousness that would put women at risk."

But mammographers know the failures inspectors found can be critical:

Mary Ellen Morrissey, Mammographer, Melrose-Wakefield Hospital
"Our job is to save women’s lives."

When quality control tests are missed, developing machines don't work. Films are improperly processed and that can cause x-ray mistakes.

Hank Phillippi Ryan
"What could that mean for the patients health, or diagnosis?"

Mary Ellen Morrissey, Mammographer
"Well, something could get missed, and therefore the patient would go another year and it would be a missed diagnosis."

And waiting for the next annual mammogram could have devastating consequences.

Dr. Suzanne Parisian, Former FDA Chief Medical Officer
"If cancer isn't picked up early, the woman could die."

And what happens when inspectors find violations? Though letters like these - sent to Massachusetts facilities warn of "serious underlying problems that could compromise the quality of mammography" - penalties are rare. Facilities promise to make corrections and are often not re-inspected until the next year.

But patients generally are not notified, and though inspection reports are public documents, they're difficult to get.

The FDA suggested making a Freedom of Information request. But when we tested how long that would take, we were told:

"Significant backlog."

"Quite a backlog."

"It depends."

And:

"I have no idea."

Compare that to Michigan, where health officials put the results online.

Hank Phillippi Ryan
"What do you think when you see this?"

We showed the inspection reports to the National Breast Cancer Coalition

Carol Matyka, National Breast Cancer Coalition
"We think this information should be available. Accountability in the system is essential to quality care."

But Sandra Ferguson--now recovering from her partial mastectomy- wonders why the system that's supposed to protect her--seems to be keeping secrets.

Sandra Ferguson
"I believe women are being kept in the dark."

Federal and state officials say there are no plans to put inspection results online--so we did.

Click here for state and federal mammography inspection results provided by the Massachusetts Department of Public Health: