Health & Medicine
FDA Issues Warning Over Laparoscopic Power Morcellation Tool
Kathleen Lees
First Posted: Apr 17, 2014 11:26 PM EDT
The U.S. Food and Drug Administration (FDA) issued a warning Thursday regarding a common surgical procedure that's used to remove uterine fibroids and benign tumors. Though this procedure is thought to usually cause no risk, new data shows that the laparoscopic power morcellation involves a electronic device that could significantly harm a women's chance of long-term survival, according to Reuters.
Chief scientist for the FDA's Center for Devices and Radiological Health, William Maisel, did a literature review that showed how one in 350 women who undergo the procedure had an unknown uterine sarcoma. The Boston Globe notes that at this time, there are no reliable tests to determine if the sarcomas are cancerous prior to removal.
Though many women suffer from uterine fibroids, which are typically of no risk, certain cases involving frequent urination, heavy menstrual bleeding or increased pelvic pressure may require surgical intervention. In fact, as many as 50,000 procedures are performed every year involving this power tool.
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.
Fortunately, the vast majority of patients that have undergone these procedures have done so safely.
For more information regarding the FDA's recommendations, click here.
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First Posted: Apr 17, 2014 11:26 PM EDT
The U.S. Food and Drug Administration (FDA) issued a warning Thursday regarding a common surgical procedure that's used to remove uterine fibroids and benign tumors. Though this procedure is thought to usually cause no risk, new data shows that the laparoscopic power morcellation involves a electronic device that could significantly harm a women's chance of long-term survival, according to Reuters.
Chief scientist for the FDA's Center for Devices and Radiological Health, William Maisel, did a literature review that showed how one in 350 women who undergo the procedure had an unknown uterine sarcoma. The Boston Globe notes that at this time, there are no reliable tests to determine if the sarcomas are cancerous prior to removal.
Though many women suffer from uterine fibroids, which are typically of no risk, certain cases involving frequent urination, heavy menstrual bleeding or increased pelvic pressure may require surgical intervention. In fact, as many as 50,000 procedures are performed every year involving this power tool.
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.
Fortunately, the vast majority of patients that have undergone these procedures have done so safely.
For more information regarding the FDA's recommendations, click here.
See Now: NASA's Juno Spacecraft's Rendezvous With Jupiter's Mammoth Cyclone