FBI investigating surgical device that may spread uterine cancer

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Thursday, May 28, 2015
Device linked to cancer in women
Marci Gonzalez reporting

SAN FRANCISCO (WABC) -- A surgical device, once used on tens of thousands of women every year, is now suspected of spreading cancer in some cases.

Now, the FBI now looking into the laparoscopic power morcellator.

It is used to treat fibroids, or benign uterine tumors that affect up to half of women under 50, by breaking the fibroids into pieces so they can be more easily removed.

But in as many as one in 350 cases, cancer is hidden in that fibroid and can be inadvertently spread by the device.

Dr. Amy Reed says it happened to her. The anesthesiologist says she was checked for cancer before a hysterectomy last fall, and the results came back negative. But then, after the morcellation, doctors did find a rare form of cancer.

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

Johnson and Johnson was the top manufacturer of the device, and the FBI is now looking into what they knew and when they knew it.

The medical supply powerhouse was first alerted to the possible risk in 2006 by a pathologist, but it didn't pull the device off the market until July of last year, doing so voluntarily "due to the continued uncertainty" and adding "to date, we are the only manufacturer to proactively take this action."

The FBI's investigation comes after the FDA warned in November that morcellators should not be used on most women. Many hospitals across the country have reportedly stopped or cut back on their use of the device.