The U.S. Government Accountability Office has been asked by twelve members
of Congress to investigate claims relating to power morcellators. The
GAO investigates how American tax dollars are spent and is often known
as the “congressional watchdog.” Specifically, the GAO has
been charged with determining why the devices were marketed for two decades
prior to safety warnings being issued by the FDA.
What is a Power Morcellator?
The power morcellator is a small electrical instrument with sharp, rotating
blades. The morcellator breaks large tissue masses apart during a hysterectomy,
myomectomy or during the removal of fibroid tumors. Once those tissues
are shredded, they are vacuumed out of the woman’s body. In theory,
the morcellator allows surgeons to perform the procedure with a much smaller
incision, avoiding large cuts into the surrounding stomach muscles. The
smaller incision allows patients to heal much more quickly, with fewer
complications. Unfortunately, as the tissue shreds are removed from the
body, they can be deposited into other areas. If a woman had undetected
uterine cancer, the use of a power morcellator can inadvertently scatter
cancerous tissue, leading to serious or even deadly consequences.
Two Doctors Campaign for a Ban on Power Morcellators
Anesthesiologist Amy Reed underwent a hysterectomy using a power morcellator
in October 2013. Soon after, Reed was diagnosed with leiomyosarcoma, a
rare, very aggressive uterine cancer. Reed’s husband, Hooman Noorchashm,
a heart surgeon, joined with Reed following her diagnosis, to launch a
campaign which would have banned the use of power morcellators. After
about a year in apparent remission, Reed recently suffered a recurrence
of the cancer following a move by Reed, Noorchashm and their six children
The campaign spearheaded by the two doctors
did result in an FDA review as well as a sharp decline in the use of power
morcellators. According to the FDA, one in 350 women who undergo a procedure
such as a hysterectomy, myomectomy or fibroid removal could have a hidden
cancer which the morcellator could spread. When the power morcellator
was first marketed in 1993, gynecologists placed that risk at one in 10,000.
The letter sent by the twelve Congress members asks the question “How
did they get it wrong for so long?”
Lead signer, Representative Mike Fitzpatrick, is pushing for sweeping changes
in the FDA’s approval process for medical devices. Spokesman for
the Government Accountability Organization, Chuck Young, stated a variety
of factors would be considered in in their determination of whether an
investigation is warranted. Those factors include the level of available
data as well as potential legal obstacles involved.
FDA Considers it “Premature” to Discuss Potential Actions for
Following the safety advisory issued by the FDA regarding the use of power
morcellators, Johnson & Johnson suspended worldwide sales of its own
power morcellator. At the time the safety advisory was issued, the FDA
deemed it premature to discuss potential actions associated with power
morcellator use. Noorchashm disagrees with this assessment passionately.
Leiomyosarcoma, the type of cancer his wife developed following a procedure
using a power morcellator, is very aggressive. Spreading it throughout
the body can make a less-than-positive prognosis even bleaker.
Noorchashm believes the FDA is well within its purview to ban the use of
power morcellators. Two key groups—the American College of Obstetricians
and Gynecologists and the AAGL—disagree, saying power morcellators
have a valuable role in patient care. Of the more than 400,000 hysterectomies
performed each year across the nation, nearly 12 percent use a power morcellator.
This means approximately 46,000 women who could have an undetected uterine
cancer could be subjected to having that aggressive cancer spread throughout
their body. Both groups advocate using the power morcellator with an isolation
bag which contains uterine tissues—but brings certain technical problems.
While the FDA has the power to ban a device which offers significant risks
of illness or injury, the agency rarely exercises that power. Until the
GAO determines whether the issue warrants investigation, patients undergoing
hysterectomies, myomectomies or fibroid removal should ask their doctor
whether a power morcellator will be used, and should discuss the risks
associated with morcellators thoroughly.
National Dangerous Drug Lawyers
If you or someone you love has been diagnosed with advanced stage uterine
cancer after your physician used a morcellator during your hysterectomy,
you may be able to file a lawsuit. To learn more about your legal options
or to schedule a free consultation call the
Philadelphia product liability lawyers at Golomb & Honik today at 215-278-4449 or fill out our confidential
The national product liability lawyers at Golomb & Honik have successfully
represented individuals in Philadelphia, Pennsylvania, New Jersey, and
throughout the United States.