PITTSBURGH (KDKA) – The FBI is now investigating Johnson & Johnson over a device used to treat thousands of women for a common problem.
The company pulled the device off the market last year after some patients were diagnosed with cancer and others died.READ MORE: Allegheny Co. Executive Rich Fitzgerald Says Amazon Air Is First-Class Deal For Pittsburgh International Airport
The question now is, did the company know the device could spread cancer and for how long?
“I had fibroids that were becoming increasingly problematic after my last pregnancy,” Dr. Amy Reed said.
A year-and-a-half ago, Reed, an anesthesiologist and mother of six, had a hysterectomy for uterine fibroids. They used a device called a morcellator which grinds the uterus into pieces so it can be removed through a small hole.
Little did she or her doctors know, she had cancer hidden in her uterus which was literally spread throughout her belly with the morcellation procedure, turning what was likely a localized disease into stage four metastatic cancer.
“This type of cancer, I said it’s like ink. Once you spill it, you can’t just go back and undo it,” Dr. Reed said.
Reed and her husband, Dr. Hooman Norchasm have been fighting to get morcellation banned.
“Morcellator was in the marketplace for 20 years and it was hurting people at a rate of 1 in 300 or 1 in 350 whatever that magic number is and no one knew about it. The FDA didn’t know about it and these folks would just go home and die,” Dr. Norchasm said.READ MORE: CDC Says Vaccinated People Can Go Maskless In Most Places, But Some Businesses Still Require It
Last year, the FDA issued strong warnings on the product label and a division of Johnson & Johnson, the largest maker of the device, advised doctors to stop using it and pulled it from the market.
Now, the Wall Street Journal reports that the FBI will investigate what Johnson & Johnson knew about the risks all along.
Reed is now 42 and her cancer recently returned. She’s had more surgery and radiation, but she and her husband worry about the future.
“Am I worried? Yes, daily. I’m worried every day. It’s like having a gun to your head. But, I also think that we will beat this thing,” Dr. Norchasm said.
“I think having kids forces you to be very forthcoming and very honest and they say what is it? Cancer. Will it kill you? And you say, I don’t know, which is the truth,” Dr. Reed said.
One of their concerns is that medical devices don’t undergo the same scrutiny as medications in this country and that doctors using them don’t always know what the risks are.
Though Johnson & Johnson pulled their morcellation device off the market, there are other companies that still make them.
As of August 2014, UPMC stopped using morcellators. Allegheny General and St. Clair hospitals aren’t using them either.MORE NEWS: Christian Ross Facing Arson Charges In Massive Fire That Destroyed Historic South Side Building