July 30 Johnson & Johnson said on
Wednesday it plans to ask doctors to return its power
morcellators, a controversial surgical device that may
inadvertently spread cancer in women being treated for uterine
growths called fibroids.
J&J's Ethicon unit in April suspended sales and distribution
of the devices while their role in treating symptomatic fibroid
disease is reviewed by the U.S. Food and Drug Administration and
the medical community. The FDA had advised doctors not to use
the devices pending further review.
On Thursday, J&J will take the further step of reaching out
to customers to ask them to return the devices they have already
purchased in what it is calling "a worldwide market withdrawal"
of all Ethicon morcellation devices that remain on the market,
an Ethicon spokesman said.
The morcellators are used to cut up the uterine growths so
they can be more easily removed using non-invasive procedures.
They are also used in hysterectomies.
However, the masses may sometimes be malignant, which is
often not detected prior to surgery, and the spinning blade of
the morcellators could spread deadly cancer and worsen patient
outcomes, the FDA had warned.
"Due to this continued uncertainty, Ethicon believes that a
market withdrawal of Ethicon morcellation devices is the
appropriate course of action at this time until further medical
guidelines are established and/or new technologies are developed
to mitigate the risk," the company said in an e-mailed
(Reporting by Bill Berkrot; Editing by Dan Grebler)