FDA Warns of Cancer Risk with Uterine Procedure
A couple of months ago, we retold the shocking story of Dr. Amy Reed, an anesthesiologist who had otherwise routine surgery to remove uterine fibroids (benign growths), and who later was found to have advanced cancer, apparently as the result of the process by which the fibroids were removed.
Now, federal officials have warned the medical community about using the procedure, as explained on AboutLawsuits.com. About 500,000 women in the U.S. undergo hysterectomies each year, and more than 200,000 of them do so to remove uterine fibroids. About 50,000 of those operations involve power morcellation.
Morcellation cuts or grinds the tissue to be removed into tiny pieces so they can be extracted through a small incision. When morcellation is performed by a device with a spinning blade, it can spray bits of uterine tissue or fibroids around the surgical cavity. That tissue can grow on other organs, causing pain, infection or bowel obstruction, and the blades can cut abdominal organs and blood vessels.
But sometimes, morcellation also appears to spread cancer cells throughout the patient’s abdomen, and the result can be advanced cancer.
In issuing the warning earlier this month, the FDA said power morcellation used during surgery to remove the uterus (hysterectomy) or uterine fibroids (myomectomy) could reduce the patient’s likelihood of long-term survival.
Its report suggested that about 1 out of every 350 women undergoing power morcellation might have unsuspected uterine sarcoma, which is a type of uterine cancer that otherwise could remain contained, but can be spread by the procedure.
“For this reason,” according to the report, “and because there is no reliable method for predicting whether a woman with fibroids may have uterine sarcoma, the FDA discourages the use of laparoscopic [small incision] power morcellation during hysterectomy and myomectomy for uterine fibroids.”
The agency reached that conclusion after analyzing 18 studies involving patients who underwent the surgery between 1980 and 2011.
Women considering surgery to remove their uterus or uterine fibroids should discuss all of their treatment options with their doctor. They should ask if power morcellation will be used during a hysterectomy or myomectomy performed via small incision, or laparoscopy. And those who already have had such a procedure should follow up with their physician, and ask questions if they have persistent or recurring symptoms. Generally, tissue removed during the procedure is tested for signs of cancer.
According to the National Institutes of Health (NIH), “Most American women will develop fibroids at some point in their lives. One study found that, by age 50, 70 percent of whites and 80 percent of African Americans had fibroids. In many cases, fibroids are believed not to cause symptoms, and in such cases women may be unaware they have them.”
But sometimes, uterine fibroids can lead to infertility, miscarriage and early onset of labor.
To learn more about uterine fibroids, read the NIH fact sheet.
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