July 8 A uterine surgical technique that has
been linked with the spread of a rare type of cancer poses a
serious concern to regulators that will be addressed this week
by an advisory committee to the U.S. Food and Drug
In preparatory documents posted on the agency's website on
Tuesday, FDA reviewers said laparoscopic power morcellator
devices, which are used to treat uterine fibroids, allow for
less invasive surgeries, shorter recovery time and fewer wound
Risks, however, include injury to local tissues and organs
and, most importantly, the spread of unsuspected malignant
uterine tissue to places outside the uterus. The advisory panel
will meet July 10-11 to discuss potential ways to mitigate these
risks and potential changes to the design of the devices and to
the label and directions for use.
Power morcellators are used to slice fibroid and uterine
tissue into small pieces that can be removed through a small
opening during surgery. The procedure is used in an estimated
50,000 U.S. uterine surgeries each year.
In April the FDA issued an alert discouraging use of the
devices to remove fibroids due to cancer concerns. Fibroids are
often benign but can cause pelvic pain and bleeding. Sometimes a
hysterectomy is needed to remove them.
The FDA estimates 1 in 350 women who have fibroid surgery
have an unsuspected uterine cancer. Following the agency's
advisory some hospitals have suspended or restricted the
procedure pending the outcome of the advisory committee meeting.
Johnson & Johnson's Ethicon unit, the biggest maker
of morcellator devices, suspended sales, distribution and
promotion of the products following the FDA advisory.
Matthew Johnson, a J&J spokesman, said the suspension will
be in effect "until their role is better understood and
redefined by the medical community."
(Reporting by Toni Clarke in Washington; Editing by Paul Simao)