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Medical device actually spreads cancer in women, FDA warns


Power morcellator

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(NaturalNews) A medical procedure used on women preparing to undergo surgery for uterine fibroids may actually spread cancer throughout the body, potentially turning easily treated cancers into life-threatening forms, the FDA has warned.

The procedure, performed by a device known as a power morcellator, consists of pulverizing uterine fibroids prior to surgery, in order to allow their removal with a much smaller incision. If there is any cancer in the uterus, however, power morcellation also shatters the tumors, spreading cancerous tissue through the abdomen and potentially inducing metastasis. Because it is impossible to determine if a women has uterine cancer before performing the surgery, there is no way to prevent this risk.

"There is no reliable way to determine if a uterine fibroid is cancerous prior to removal," said Dr. William Maisel, deputy director for science and chief scientist of the FDA's Center for Devices and Radiological Health. "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."

According to the FDA, two dozen women had their uterine cancers worsened by power morcellation in the last year alone.

"We believe that in the vast majority of women, the procedure should not be performed," Maisel said.

One in 350 had their cancer worsened

Uterine fibroids are non-cancerous growths in the smooth muscle tissue of the uterine wall that most women develop at some point in their lives, typically without symptoms. In some cases, however, the condition can cause problems severe enough to warrant surgery.

Traditional treatments for uterine fibroids include a full surgical hysterectomy or myomectomy, laparoscopic ("keyhole") hysterectomy or myomectomy, and non-surgical interventions. In recent years, power morcellation became a popular pre-treatment to laparoscopy.

Concerns began to arise about the procedure last year, however, after Amy Reed, a doctor married to a surgeon, underwent power morcellation and developed stage 4 cancer as a result. Although Reed was fortunate enough to recover, her husband Hooman Noorchashm has since led a campaign to get the procedure banned. In April, a major manufacturer of the devices pulled them from the market, leading to a significant drop in the number of procedures performed. Many hospitals (including the one that performed Reed's surgery) have stopped using the devices.

According to Maisel, approximately 50,000 women per year might have used power morcellation prior to April 2014. One in 350 of those would have experienced a spread in uterine cancer as a result.

Because morcellated tissue is analyzed immediately following the procedure, the FDA believes that all cases of cancer were identified, Maisel said. Women who underwent power morcellation but did not hear from their doctors should have no need to fear.

Discouraged, but not banned

The FDA announcement stopped short of an outright ban on the procedure, instead advising strongly against it and urging both women and their doctors to discuss all available treatment options, including the risks and benefits of each. The agency has also called on manufacturers of power morcellators to revise the product labels, and is considering the implementation of a black box warning.

"Input from clinical and scientific experts will help provide valuable information and perspectives to clarify the proper clinical role for these devices," Maisel said.

Part of the reason the FDA did not ban the devices, Maisel said, is that they might still be useful in younger women with a low risk of uterine cancer, in order to help them lower the risk of uterine surgery resulting in infertility.

Noorchashm, in contrast, still insists that the devices should be banned.

Sources:

http://www.ksdk.com

http://www.fda.gov

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