FBI probing what J&J knew
about uterine surgery device: WSJ
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[May 28, 2015]
(Reuters) - The Federal Bureau of
Investigation is probing a surgical tool found to spread uterine cancer
and what Johnson & Johnson knew about its risks before withdrawing its
version of the device last year, the Wall Street Journal reported.
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J&J said in July that it would ask doctors to return the device,
called laparoscopic power morcellator, which is used to treat
uterine growths called fibroids.
It is unclear what stage the inquiry is in, the Journal reported,
citing three people who have been interviewed.
A J&J spokesman said the company has not been contacted by the FBI
regarding its Ethicon morcellation devices.
The U.S. Food and Drug Administration tightened its guidelines on
the use of a uterine surgical technique in November, saying it has
been linked to the spread of a rare type of cancer.
This came after the agency issued an alert in April last year
discouraging the use of the devices to remove fibroids.
The devices are used to slice fibroid and uterine tissue into small
pieces inside the body, allowing it to be removed through a small
opening. The procedure is designed to shorten recovery time and
reduce wound-site infections.
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Yet the technique can cause injury to local tissues and organs and
spread unsuspected malignant tissue to places outside the uterus.
(Reporting by Ankur Banerjee in Bengaluru; Editing by Kirti Pandey)
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