FDA advisers weigh risks of procedure for removal of uterine fibroids

July 14, 2014 by Dennis Thompson, Healthday Reporter
FDA advisers weigh risks of procedure for removal of uterine fibroids
No guarantee that devices won't increase chances of spreading cancer to other parts of a woman's body, experts say.

(HealthDay)—There's no way to guarantee that a surgical technique used to grind up uterine growths and remove them through tiny incisions won't increase the risk of spreading cancer to other parts of a woman's body, U.S. health advisers said Friday.

The advisory panel to the Food and Drug Administration also said that women who do undergo the procedure—called laparoscopic power morcellation—should sign a written consent stating that they understand the potential risks, the Associated Press reported.

The panel's advisory opinion follows an April 17 warning from the FDA that the procedure can inadvertently spread cancerous tissue beyond a woman's uterus and into other parts of her body.

The FDA hasn't set a decision date on the use of power morcellator devices, the AP said. The agency isn't obliged to follow the advice or recommendations of its advisory committees but usually does so.

Surgeons frequently use laparoscopic power morcellation when they perform a hysterectomy or remove uterine fibroids, which are noncancerous growths on the smooth muscle tissue on the wall of the uterus.

The minimally invasive procedure uses a power tool to chop up the tissue of the fibroids or, in the case of a hysterectomy, the uterus itself. These tissue fragments are then removed through tiny incisions, according to background information from the FDA.

The agency estimates that about one in 350 women undergoing a hysterectomy or fibroid removal has an unsuspected type of cancer called uterine sarcoma.

If a surgeon performs power morcellation on these women, there's a risk the procedure will spread the within the patient's abdomen and pelvis.

About 60,000 of these procedures are performed every year, estimated Dr. William Maisel, deputy director for science and chief scientist at the FDA's Center for Devices and Radiological Health.

The FDA stopped short in April of banning the power morcellation devices from the market, but is urging physicians and patients to weigh the risks prior to their use.

"Women should ask their if power morcellation will be used during the procedure, and explain why it's the best option," Maisel said at an April 17 news conference.

Women who already have undergone power morcellation don't need to get a cancer screening, because some of the tissue removed during the procedure would have been sent for pathologic analysis, Maisel said. If cancer had been detected, they would have been informed, he added.

"We think that most women who have undergone these procedures require routine care," he said. "If they don't have any ongoing or recurrent symptoms, they should be fine."

Most women will develop at some point in their lives, according to the U.S. National Institutes of Health. These fibroids can cause symptoms such as heavy or prolonged menstrual bleeding, pelvic pain or frequent urination.

Women who need a or fibroid removal can still undergo traditional or laparoscopic surgery, just without the use of a power morcellator, Maisel said.

The agency has instructed manufacturers of power morcellators to review their current product labeling for accurate risk information for patients and health care professionals.

The FDA approved the first power morcellator for use in 1995, Maisel said. A non-power version of the morcellator received FDA approval in 1991.

The medical community has been aware of the risk of cancer spread during power morcellation since the devices came onto the market, Maisel said, but "the magnitude of the risk appears to be higher than what was appreciated in the clinical community."

Explore further: FDA warns of risks with fibroid removal procedure (Update)

More information: For more about uterine sarcoma, visit the U.S. National Cancer Institute.

Related Stories

FDA warns of risks with fibroid removal procedure (Update)

April 17, 2014
The Food and Drug Administration is warning American women that a device-assisted procedure for treating fibroids could inadvertently spread cancer from the uterus to other parts of the body.

Patients seek US ban on fibroid removal devices

July 11, 2014
More than a dozen Americans—including cancer patients, their family members and physicians—called on U.S. health regulators on Friday to block the use of electronic surgical tools used to remove fibroids, but which can ...

FDA weighs cancer risk of fibroid removal devices

July 12, 2014
Federal health advisers say there is little to no evidence that a popular technique for removing fibroids can be performed without the risk of spreading undetected cancers to other parts of the body.

J&J halts sale of electric fibroid removal devices

April 30, 2014
Johnson & Johnson is halting sales of devices used to remove growths in the uterus following a government warning that the electronic surgical tools can inadvertently spread cancer to other parts of the body.

Fibroids are common problem for women

April 1, 2014
Uterine fibroids are very common, occurring in as many as 50 percent of women in their reproductive years and up to two-thirds of women by the time they go through menopause. While many fibroids cause no problems and require ...

Journal Maturitas publishes position statement on management of uterine fibroids

June 16, 2014
Journal Maturitas today announced the publication of a position statement by the European Menopause and Andropause Society (EMAS) on the topic of the management of uterine fibroids.

Recommended for you

Drug may help surgical patients stop opioids sooner

December 13, 2017
(HealthDay)—Opioid painkillers after surgery can be the first step toward addiction for some patients. But a common drug might cut the amount of narcotics that patients need, a new study finds.

Children best placed to explain facts of surgery to patients, say experts

December 13, 2017
Getting children to design patient information leaflets may improve patient understanding before they have surgery, finds an article in the Christmas issue of The BMJ.

Burn victim saved by skin grafts from identical twin (Update)

November 23, 2017
A man doomed to die after suffering burns across 95 percent of his body was saved by skin transplants from his identical twin in a world-first operation, French doctors said Thursday.

Is a common shoulder surgery useless?

November 21, 2017
(HealthDay)—New research casts doubt on the true effectiveness of a common type of surgery used to ease shoulder pain.

Study shows electric bandages can fight biofilm infection, antimicrobial resistance

November 6, 2017
Researchers at The Ohio State University Wexner Medical Center have shown - for the first time - that special bandages using weak electric fields to disrupt bacterial biofilm infection can prevent infections, combat antibiotic ...

Obesity increases incidence, severity, costs of knee dislocations

November 3, 2017
A new study of more than 19,000 knee dislocation cases in the U.S. between 2000 and 2012 provides a painful indication of how the nation's obesity epidemic is changing the risk, severity and cost of a traumatic injury.

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.