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FDA Warns Device Used In Common Uterine Fibroid Surgery May Spread Cancer

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The U.S. Food and Drug Administration issued a warning Thursday that a common surgical procedure used to remove uterine fibroids, benign tumors that usually pose no risk, could spread undetected uterine cancer, Reuters reported.

New data shows that the procedure laparoscopic power morcellation involves an electronic device that could significantly worsen a women's chance of long-term survival, Reuters reported.

During a conference call with journalists, William Maisel, chief scientist for the FDA's Center for Devices and Radiological Health, said the federal agency did a literature review that revealed one in 350 women who undergo the procedure

Maisel said the agency did a literature review that revealed one in 350 women who undergo the procedure, called power morcellation, "has an unknown uterine sarcoma," the Boston Globe reported.  He said there exists no reliable tests to determine if they the uterine sarcoma are cancerous prior to removal.

Although uterine fibroids usually pose no risk, certain women suffer from symptoms that include pelvic pressure, frequent urination and heavy or prolonged menstrual bleeding, which could warrant surgical intervention.

Approximately 50,000 procedures are performed every year using the powered tool in the United States, according to Maisel.

Surgeons were aware that there was some risk of cancer spreading as a result of the procedures, but "the magnitude of the risk is higher than had been appreciated by the medical community," Maisel said.

"The vast majority of patients that have undergone this procedure have done so safely," he added.

The FDA's review was prompted by media coverage of the case of Dr. Amy Reed, an anesthesiologist in Boston "who underwent a hysterectomy at Brigham and Women's Hospital in October to treat what she was told were likely benign fibroids," the Boston Globe reported.

Follow-up tests found that Reed had uterine leiomyosarcoma. The cancer had spread throughout her abdominal cavity during the laparoscopic procedure.

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