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 The company said it is suspending the sale of its
power morcellators until their role in fibroid treatment is better
understood and redefined by the medical community.
The action follows a Food and Drug Administration advisory on April
17 that discouraged doctors from using laparoscopic power
morcellators to remove fibroids because of a risk of worsening an
often-hidden cancer. (http://r.reuters.com/dug68v)
"Ethicon morcellation devices have always included cautions in their
instructions for use about the potential spread of malignant
tissue," J&J wrote in a letter to customers, a copy of which is
available with Reuters.
J&J said the step was not a product removal as the FDA maintained
that power morcellation may still be the best option for some
patients after risk evaluation and informed consent.
The FDA was not immediately available for comment outside regular
U.S. business hours.
"We are also reaching out to regulatory agencies around the globe as
this is a global notification," J&J spokeswoman Sheri Woodruff told
Reuters.
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Laparoscopic power morcellation is one of several available
treatments for fibroids. It is a procedure that uses a medical
device to divide the uterine tissue into smaller pieces or fragments
so it can be removed through a small incision in the abdomen. Uterine fibroids are non-cancerous growths that originate from
the smooth muscle tissue in the wall of the uterus.
(Reporting by Supriya Kurane and Arnab Sen in Bangalore;
editing by Gopakumar Warrier)
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