Johnson and Johnson (JNJ)

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FBI starts probing J&J’s medical device linked to uterine cancer
Written by Tanya Campbell on 30 May 2015

FBI starts probing J&J’s medical device linked to uterine cancer
Investigators from the Federal Bureau of Investigation (FBI) have started probing a surgical gynecological tool that has repeatedly been linked to spreading of uterine cancer in women during a procedure. The controversial took belongs to pharmaceutical products maker Johnson & Johnson (J&J).

According to the investigation by FBI, the pharmaceutical company Johnson & Johnson, the largest manufacturer of the power morcellator, was familiar about the risk of the device and didn't warn customers and physicians. As per the reports, the device was pulled off in 2014, but some other morcellator manufacturers continued selling the device.

A spokeswoman from the FBI, New Jersey office, did not disclose anything about the investigation. On the other side, a spokesperson for Johnson & Johnson's Ethicon division said that the company has not been contacted by FBI regarding the device.

The Wall Street Journal contacted the three individuals who were questioned by the FBI office in Newark about the morcellator device. An anesthesiologist, Dr. Amy Reed, has been among the people contacted by the FBI. Reed underwent a hysterectomy for fibroid removal about two years ago just to find out that the morcellator had made her cancer worse. Currently, Reed and her husband have been protesting to ban the device to save women's lives.

Sarah Robinson, a physician assistant in Los Altos, was also contacted by the FBI about two months ago. While talking to the Wall Street Journal, Robinson said she was testified at a Food and Drug Administration hearing on the device. According to Robinson, she also created a list of ladies families who were supporting the ban of morcellator device. She sent a list of about 386 people to FBI.

The investigation by FBI followed a warning that was issued by FDA in November 2014. The warning said, "The device shouldn't be used on the vast majority of women. One in 350 who underwent the procedure had an unsuspected cancer sarcoma." The agency also called for a 'black-box' warning on the tool.