FBI Investigating Johnson & Johnson Hysterectomy Device
BOSTON (CBS) - WBZ-TV first introduced you to the Needham mom who developed metastatic cancer after undergoing a morcellation procedure to treat her uterine fibroids.
Due in large part to her and her husband's campaign to stop the practice, a company that manufactured the device is now being investigated by the Feds.
A year and a half ago, Dr. Amy Reed, an anesthesiologist and mother of six, had a hysterectomy for uterine fibroids at a local hospital. They used a device called a power morcellator which grinds the uterus into pieces so it can be removed through a small hole.
Little did Amy or her doctors know, she had cancer hidden in her uterus which was literally spread throughout her belly with the morcellation procedure, turning likely localized disease into stage four metastatic cancer.
"They spread cancer all around," says Amy. "This type of cancer I say is like ink. Once you spill it, you can't just go back and undo it."
Amy and her husband, Dr. Hooman Norchasm, have been fighting since her diagnosis to get morcellation banned.
"The morcellator was in the marketplace for 20 years," Hooman says. "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," he adds.
Last year the FDA issued strong warnings on the product label and a division of Johnson & Johnson, the largest manufacturer of the device, advised doctors to stop using it and pulled it from the market. Now, the Wall Street Journal is reporting that the FBI will investigate what Johnson & Johnson knew about the risks all along.
Amy is now 42 years old, and her cancer recently returned. She's had more surgery and radiation but she and Hooman concerned about the future.
"Am I worried? Yes. Daily," he said. "It's like having a gun to your head, but I also think that we will beat this thing."
"I think having kids forces you to be very forthcoming and very honest," says Amy. "They say, 'What is it?' 'Cancer.' 'Will it kill you?' And you say 'I don't know, which is the truth.'
One of their concerns is that medical devices don't undergo the same scrutiny as medications in this country, and that the 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.