More reports on: Pharmaceuticals

FBI probes role of J&J's hysterectomy device in spreading cancer

news
30 May 2015

The Federal Bureau of Investigation is investigating whether the medical community neglected to report potentially fatal side-effects of a hysterectomy surgical tool, according to a doctor who said he had been interviewed by the agency.

According to Hooman Noorchashm, a thoracic surgeon who had crusaded vigourously against the device, after his wife's routine hysterectomy spread her cancer, said he had been interviewed several times by agents from the FBI's Newark office.

Ethicon, the Somerville-based division of Johnson & Johnson, is the largest manufacturer of the device called a morcellator.

According to a company spokesman, it had not been contacted by the FBI.

The device, a power shaver on the end of a thin tube is inserted through a tiny incision into the uterus to mince and suction out tissue. This form of laparoscopic surgery had been popular with women due to the reduced scarring and recovery time as against a conventional hysterectomy.

The problem, which turned out to be much more common than earlier reaslied, was that the device could splatter undetectable cancer throughout the abdominal cavity, turning what at the onset of surgery was a Stage 1 cancer into a Stage 4 cancer at its conclusion.

The US Food and Drug Administration last year issued a warning against use the device for most hysterectomies, saying, the risks were simply too high.

Johnson & Johnson suspended sales of the device in response.

"In July 2014, we voluntarily withdrew all of the Ethicon devices, and Ethicon morcellation devices remain off the market. We are the only manufacturer of these devices to have taken such action," the company said in a statement.

Meanwhile, The Wall Street Journal reported that federal agents had been calling patients and pathologists to ask about the device.

According to Peter Weiss, an attending physician at Providence St John's Health Center in Santa Monica, that morcellators came with a risk had been known for a while to medical professionals, CBS Los Angeles reported.

He added, he had used the morcellator only sparingly because he's always cautious about new technology.

''Anything that comes out new and it sounds wonderful and exciting, you have to always have a little bit of reservation until we have enough time lag to go back and say, 'What really are the benefits? What really are the risks?' '' he said.

 





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