By Stephanie Stahl
PHILADELPHIA (CBS) — It’s a story Eyewitness News health reporter Stephanie Stahl first told you about: a surgical tool suspected of spreading cancer in women. Now, the FBI is reportedly investigating who knew what and when about this potentially deadly device.
The question being asked: whether medical device makers, doctors and hospitals broke the law by failing to report problems linked to the device.
The device, used in gynecological procedures, has been linked to several deaths and a number of injuries. The FDA has allowed it to stay on the market, but says it shouldn’t be used on most women. The FBI was contacted by a couple Eyewitness News has been reporting on: Dr. Amy Reed, a cancer patient, and her husband, Dr. Hooman Noorchashm.
Dr. Reed has 6 children and a deadly cancer that she and her husband say was caused by a surgical device they say should have never been used.
Now the FBI is reportedly investigating why a potentially dangerous device was used on thousands of patients for years.
“It’s about time that some federal agency looks to see what was known, who knew it, and why it wasn’t reported,” said Dr. Noorchashm.
The doctors have been on a mission since his wife, 42, was first diagnosed with cancer after an operation in 2013. They say it was caused by a device called a morcellator, used to shred fibroid tumors so they can be easily removed. But the shredding ended up inadvertently spreading cancer that hadn’t been detected.
One of the device makers, Johnson & Johnson, reportedly was told about problems with the device back in 2006. Some claim the company didn’t do enough to protect patients.
“This is a violation of federal law that has led to the loss of life, so I think that is what got the FBI’s attention,” Dr. Noorchashm said.
Dr. Reed says her situation might have been prevented, “not only mine but hundreds of other women. That’s what’s so maddening.”
Doctors and hospitals are supposed to report adverse events, which is what the FBI is reportedly investigating.
The doctors say they’ve been interviewed by federal agents several times and so have many others. The FBI won’t confirm or deny an investigation.