(Changes source, adds company comment, details on sale
April 30 Johnson & Johnson suspended
worldwide sale of its device used in fibroid surgery amid
concerns over its potential to spread undetected cancer beyond
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. (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.
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
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)