FBI investigating Johnson & Johnson device that may spread uterine cancer

Denise Dador Image
Friday, May 29, 2015
FBI investigating medical device that may spread cancer
The FBI is investigating Johnson & Johnson, one of America's largest pharmaceutical companies, and its power morcellator, a surgical instrument that may be spreading a type of cancer in women.

SAN FRANCISCO (KABC) -- Pharmaceutical giant Johnson & Johnson is being investigated by the FBI over a controversial surgical tool that may be putting women's lives at risk.

The device is the laparoscopic power morcellator, which is meant to remove things such as tumors from the uterus. It is also a device used most in hysterectomies. It breaks up fibroids, or benign tumors, in the uterus. But the item is suspected of spreading cancer cells in some women.

Now several hospitals nationwide are pulling the devices for safety reasons.

Dr. Amy Reed, an anesthesiologist from Boston, has only gotten more sick since her hysterectomy last year.

Doctors checked her for cancer before the procedure and said she was cleared. But after her surgery, a rare form of cancer was found, and she blames the device. She is now calling for the morcellator to be banned.

"At no point in time did anyone ever say, 'well you know because you had it morcellated, that worsens your prognosis,' that's something we discovered on our own," Reed said.

"If you disrupt the mass it's like a bee's hive. If you start chopping it up the bees spread and you're in trouble," said Hooman Noorchashm, Reed's husband.

The FBI probe found there is a hidden cancer in one in 350 cases of fibroids. The spinning blades on the morcellator may help spread the disease.

"The FDA has no idea how many women had cancer spread by being treated with this device. But the idea that anyone was harmed is very concerning," said Richard Besser, ABC News Chief Health and Medical Editor.

Johnson & Johnson is the largest manufacturer of the product. Johnson and Johnson was first alerted to the risks back in 2006, but voluntarily pulled the device just last year.

But now, the FBI wants to know exactly what the company knew about the risks and for how long.

Last year the FDA issued its most serious black box warning on the morcellator.