Agency recommends adding important safety information to product labels
Today, the U.S. Food and Drug Administration is taking immediate steps
to help reduce the risk of spreading unsuspected cancer in women being
treated for uterine fibroids. In an updated safety communication, originally
issued in April 2014, the FDA warns against using laparoscopic power morcellators
in the removal of the uterus (hysterectomy) or fibroids (myomectomy) in
the vast majority of women.
In an Immediately in Effect (IIE) guidance, the FDA is also recommending
that manufacturers of laparoscopic power morcellators include in their
product labeling specific safety statements in the form of a boxed warning
and two contraindications. The IIE guidance allows the FDA to issue its
recommendations expeditiously to help address a significant public health issue.
“The FDA’s primary concern is the safety and well-being of
patients and taking these steps will help the agency’s safety recommendations
to be implemented as quickly as possible,” said William Maisel,
M.D., M.P.H., deputy director for science and chief scientist at the FDA’s
Center for Devices and Radiological Health. “Updating the device
label with a boxed warning and contraindications will provide clinicians
and patients with critical information about the risk of spreading cancerous
tissue when these procedures are performed.”
The boxed warning informs health care providers and patients that:
- Uterine tissue may contain unsuspected cancer. The use of laparoscopic
power morcellators during fibroid surgery may spread cancer and decrease
the long-term survival of patients. This information should be shared
with patients when considering surgery with the use of these devices.
The two contraindications advise of the following:
Laparoscopic power morcellators are contraindicated (should not be used)
for removal of uterine tissue containing suspected fibroids in patients
who are: peri- or post-menopausal, or candidates for
en bloc tissue removal (removing tissue intact) through the vagina or mini-laparotomy
incision. (These groups of women represent the majority of women with
fibroids who undergo hysterectomy and myomectomy.)
- Laparoscopic power morcellators are contraindicated (should not be used)
in gynecologic surgery in which the tissue to be morcellated is known
or suspected to be cancerous.
The IIE guidance applies to currently marketed and new laparoscopic power
morcellators for general and specific gynecological indications.
Based on a quantitative analysis of currently available data, the FDA estimated
that approximately 1 in 350 women who are undergoing hysterectomy or myomectomy
for fibroids is found to have an unsuspected uterine sarcoma. If laparoscopic
power morcellation is performed in these women, there is a risk that the
procedure will spread the cancerous tissue within the abdomen and pelvis,
significantly worsening the patient’s likelihood of long-term survival.
The two contraindications help to clarify the narrow population of patients
in which laparoscopic power morcellation may be an appropriate therapeutic
option. For example, some younger women who are interested in maintaining
their ability to have children or wish to keep their uterus intact after
being informed of the risks may be candidates for this procedure.
“The FDA strongly encourages doctors to inform their patients of
the risk of spreading unsuspected cancer from the use of these devices
in fibroid surgery and discuss the benefits and risks associated with
all treatment options,” said Dr. Maisel.
There are other surgical treatment options available for women with symptomatic
uterine fibroids, such as traditional surgical hysterectomy (performed
either vaginally or abdominally) and myomectomy, laparoscopic hysterectomy
and myomectomy without morcellation, and laparotomy using a smaller incision
In addition to the original
safety communication and
quantitative analysis, in July 2014 the FDA convened a meeting of the
Obstetrics and Gynecology Devices Panel to discuss patient populations in which laparoscopic power morcellators
should not be used, specifically mentioning patients with known or suspected
malignancy. The panel also discussed mitigation strategies such as labeling
and suggested that a boxed warning related to the risk of disseminating
unsuspected malignancy would be useful. The panel indicated that it is
critical that doctors discuss the risks and benefits of all options with
In addition to the updated safety communication and IIE guidance, the FDA
is considering other ways to further help reduce the risk of unsuspected
cancer spread by laparoscopic power morcellation, such as encouraging
innovative ways to better detect uterine cancer and contain potentially
The agency will continue to review adverse event reports, peer-reviewed
scientific literature and information from patients, health care professionals,
gynecologic and surgical professional societies and medical device manufacturers
and may take further action in the future, if necessary.
The FDA, an agency within the U.S. Department of Health and Human Services,
protects the public health by assuring the safety, effectiveness, and
security of human and veterinary drugs, vaccines and other biological
products for human use, and medical devices. The agency also is responsible
for the safety and security of our nation’s food supply, cosmetics,
dietary supplements, products that give off electronic radiation, and
for regulating tobacco products.