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FDA discourages a uterine surgical procedure

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Due to the risk of spreading cancerous tissue, the U.S. Food and Drug Administration on April 17 began publicly discouraging the use of a particular uterine surgical procedure.

The FDA announced in a safety communication that laparoscopic power morcellation, which has been used for the removal of the uterus (hysterectomy) or uterine fibroids (myomectomy), has posed a risk of spreading unsuspected cancerous tissue, particularly uterine sarcomas, beyond the uterus.

In laparoscopic power morcellation, the surgeon uses a medical device to divide the uterine tissue into smaller pieces or fragments so it can be removed through a small incision in the abdomen.

How serious is the risk? We will let the regulatory agency speak for itself.

“Based on an analysis of currently available data,” the agency wrote, “the FDA has determined that approximately 1 in 350 women who are undergoing hysterectomy or myomectomy for fibroids have an unsuspected type of uterine cancer called uterine sarcoma. If laparoscopic power morcellation is performed in these women, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival.”

The FDA pointed out that there are safer surgical and non-surgical options.

“The FDA’s primary concern as we consider the continued use of these devices is the safety and well-being of patients,” said FDA Deputy Director for Science Dr. William Maisel, the chief scientist at the FDA’s Center for Devices and Radiological Health. “There is no reliable way to determine if a uterine fibroid is cancerous prior to removal. Patients should know that the FDA is discouraging the use of laparoscopic power morcellation for hysterectomy or myomectomy, and they should discuss the risks and benefits of the available treatment options with their health care professionals.”

Rest assured that the experienced product liability attorneys at Reich & Binstock will investigate the claims of women whose cancer may have stemmed from the use of the discouraged procedure. Patients nationwide may reach Reich & Binstock either online, through the law firm’s website, and by the law firm’s toll-free number.

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