Women Should Be Warned There Is No Way To Detect Sarcoma Before Morcellation: Study
The findings of a new study confirm that there is no way for doctors to detect uterine sarcoma before a woman undergoes a laparoscopic hysterectomy or myomectomy with morcellation, where the uterus or uterine fibroids are cut up with a medical device that may also cause this cancerous tissue to be spread throughout the abdomen.
In a report published on-line by the American Journal of Obstetrics & Gynecology on December 11, researchers from Kaiser Permanente looked at the potential risk factors that could be used to identify uterine cancer that may be hidden in fibroids before they are removed during a minimally invasive procedure that requires use of a power morcellator.
Power morcellators have become increasingly popular in recent years, allowing surgeons to perform a hysterectomy or myomectomy through a small incision in the abdomen. The device is used to grind up the tissue, which can then be removed through the port incision. However, for women with undiagnosed cancer contained within the uterus, these devices may pose a serious and potentially life-threatening risk.
Over the past year, concerns have merged within the medical community about the extent of the risk women face of morcellation spreading leiomyosarcoma, endometrial stromal sarcoma or other uterine cancers, rapidly upstaging the disease and disseminating the cancer to other areas of the body.
Kaiser Permanente researchers conducted a retrospective review of 3,523 women who underwent laparoscopic hysterectomy between 2001 and 2012.
Out of 941 patients who underwent the uterine fibroid treatment involving use of a morcellator, 10, or 1.1% were later diagnosed with uterine sarcomas or parasitic myomas. Six of those had uterine sarcoma.
The findings appear to confirm concerns that there is no way to tell before morcellation which women may be at risk from use of the device.
“There was no association between any of the factors analyzed and uterine sarcoma,” the researchers determined. “Uterine sarcoma was found in 0.6% of patients who underwent power morcellation but was not found to be significantly associated with any preoperative factors. Patients should be counseled about these complications prior to power morcellation.”
The study’s findings were published less than a month after the FDA issued a new labeling requirements for power morcellators which call for all of the devices to carry a black box warning alerting doctors and patients to the risk of spreading cancer cells. The agency also contraindicated the use of power morcellation for uterine fibroid removal in most cases.
Power Morcellator Sarcoma Risks
Power morcellators have been used in about 50,000 hysterectomy and myomectomy procedures each year, with estimates suggesting that about 1 out of 350 of these women may have unsuspected sarcoma prior to the procedure.
In response to concerns surrounding this risk, the FDA convened a panel of outside advisors over the summer to evaluate the devices. The FDA advisory panel concluded that there is no safe way to use power morcellators.
Although many have called for a power morcellator recall to be issued, the FDA announced last month that the devices will remain available with a stronger black box warning and the new contraindications.
As questions continue to be raised about the adequacy of warnings provided to women undergoing a laparoscopic hysterectomy or myomectomy for uterine fibroids, a growing number of morcellation cancer lawsuits are being filed on behalf of women subsequently diagnosed with the spread of leiomyosarcoma, endometrial stromal sarcoma or other uterine sarcoma.
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