FDA Committee Examines Cancer Risks Linked to Power Morcellation

An FDA advisory committee began meeting today, to review the risk of spreading cancer associated with power morcellation for uterine fibroid removal, and how the device may be safely used during minimally invasive hysterectomy and myomectomy procedures.

The meeting of the Obstetrics and Gynecology Devices Advisory Committee is being held today and tomorrow, following an FDA warning earlier this year that urged doctors to stop using laparoscopic power morcellators to remove uterine fibroids, due to the risk that some women may have unsuspected sarcoma in the uterus.

Power morcellators are medical devices used to cut up the uterus or uterine fibroids into small pieces, allowing the surgeons to remove the tissue through a small incision in the abdomen. However, for women with unsuspected sarcoma, power morcallation of uterine fibroids may cause cancerous cells to be spread throughout their body, quickly resulting in advanced stage cancer.

Learn More About

Morcellation Lawsuits

Power morcellators used during a laparoscopic hysterectomy or uterine fibroid surgery may cause the spread of aggressive cancer.


On April 17, the FDA issued a safety communication warning about the cancer risks with power morcellation, indicating that it would convene a public meeting of their Obstetrics and Gynecological Medical Device Advisory Committee to discuss (a) what role laparoscopic power morcellation should play in the treatment of uterine fibroids, (b) whether surgical techniques or accessories, such as tissue collection bags, may reduce the risk of spreading cancer and (c) whether stronger warnings about the cancer risks should be required for laparoscopic power morcellators.

The FDA prepared an executive summary (PDF) of its current findings for the committee, laying out the data that led the agency to conclude that power morcellation during uterine fibroid removal was too risky.

“Recent discussions within the patient and clinical communities as well as the peer-reviewed literature have raised awareness of the risk of spreading unsuspected cancerous tissue beyond the uterus when LPMs are used during surgeries intended to treat benign fibroids,” the FDA summary notes. “This iatrogenic dissemination of malignant tissue may result in the ‘upstaging’ of a tumor, thereby worsening a patient’s prognosis and likelihood for long-term survival.”

The FDA found that approximately 1 in 350 women who undergo a hysterectomy or myomectomy to remove uterine fibroids has uterine sarcoma that has not been diagnosed. About 1 in 500 have the more deadly leiomyosarcoma. With no reliable way to detect the cancers before the fibroids are removed, many hospitals have stopped using laparoscopic power morcellators.

According to the advisory committee’s agenda (PDF) posted before the start of the meetings, today’s sessions will include a general introduction to uterine fibroids, information on surgical options available for women experiencing symptoms associated with fibroids, radiological considerations in uterine fibroid disease and an overview of uterine sarcomas.

Following panel deliberations and discussion later this afternoon, the meetings are expected adjourn this evening around 6:00 p.m.

Tomorrow the meeting will feature an open public hearing, with presentations from medical professional societies, patient advocacy and research groups, as well as public presenters.

Following discussion of several questions from the FDA to the panel of outside experts, a series of recommendations are expected about how the regulatory agency should address the potential power morcellation cancer risks. While the committee’s determinations are not binding on the FDA, the agency typically follows the final recommendations of outside advisory panels.

Morcellator Cancer Lawsuits

Following the FDA warnings issued earlier this year, a number of serious questions have been raised about why women were not previously informed about the potential risk of uterine cancer being spread by power morcellation.

With no effective method available for doctors to determine if women have unsuspected sarcoma prior to surgery, many doctors and hospitals have indicated that they are suspending use of power morcellation for minimally invasive hysterectomy and uterine fibroid removals until additional information is available about the best ways to avoid the risk. In addition, Johnson & Johnson’s Ethicon division, the world’s largest power morcellator manufacturer, stopped sales and production of power morcellators earlier this year.

A number of power morcellation cancer lawsuits are now being pursued on behalf of individuals who had leiomyosarcoma, endometrial stromal sarcoma or other cancers spread during the procedures.

Plaintiffs allege that as they are currently designed, power morcellators are unreasonably dangerous. In addition, women claim that they may have avoided spreading cancer throughout their body if information about the risk had been provided to the medical community, since a number of alternative treatment options are available for women with symptomatic uterine fibroids, including traditional surgical hyesterectomy performed vaginally or abdominally, catheter-based blocking of the uterine artery, high-intensity focused ultrasound, drug therapy and laparoscopic hysterectomy or myomectomy without use of morcellation.


Share Your Comments

I authorize the above comments be posted on this page*

Want your comments reviewed by a lawyer?

To have an attorney review your comments and contact you about a potential case, provide your contact information below. This will not be published.

NOTE: Providing information for review by an attorney does not form an attorney-client relationship.

This field is for validation purposes and should be left unchanged.

More Top Stories

BioZorb Lawsuit Alleges Breast Tissue Marker Failed, Requiring Surgical Removal
BioZorb Lawsuit Alleges Breast Tissue Marker Failed, Requiring Surgical Removal (Posted yesterday)

A BioZorb lawsuit has been filed by several breast cancer survivors after the BioZorb implants moved out of place and failed to dissolve int he body, requiring surgical removal.

Fairness Hearing For Philips CPAP Recall Medical Monitoring Settlement Set for October
Fairness Hearing For Philips CPAP Recall Medical Monitoring Settlement Set for October (Posted yesterday)

A U.S. District Court judge has scheduled a fairness hearing for October in order to determine whether final approval should be granted to a $25 million Philips CPAP recall settlement agreement, which would pay former users $25 million to pay for future medical monitoring needs.

Abbott Laboratories Faces Jury Trial Over Claims Similac Caused NEC For Premature Infant
Abbott Laboratories Faces Jury Trial Over Claims Similac Caused NEC For Premature Infant (Posted 2 days ago)

Following a $60 million verdict in a similar lawsuit earlier this year, trial is underway involving claims brought by an Illinois mother, whose premature daughter developed NEC from Similac, alleging that Abbott failed to warn parents and medical staff of the devastating risks associated with the cow's milk-based formula.