Pittsburgh Hospitals Slow Power Morcellator Use after FDA Warning about Cancer Spread
A prominent network of Pennsylvania hospitals has slowed its use of surgical procedures incorporating the power morcellator, a bladed device that cuts up uterine tissue in laparoscopic hysterectomy and fibroid removal surgeries, the Pittsburgh Business Times reports.
According to an article on June 18th, a spokesperson for the University of Pittsburgh Medical Center (UPMC) said it “drastically reduced” its use of power morcellators after the U.S. Food and Drug Administration (FDA) warned two months ago of their potential to spread uterine cancer. Although the Pennsylvania hospital network, which is comprised of 20 facilities, issued its public statement in June, officials say the cutback coincided with an FDA warning on April 17, 2014 that power morcellators may disseminate cancer cells outside the uterus and into other parts of the peritoneal cavity. 1 in every 350 women undergoing fibroid removal procedures has undetected cancer cells prior to surgery, according to the FDA, which could make the possibility even more dangerous.
Ethicon Suspends Power Morcellator Sales Pending FDA Review
After the FDA alert in April, Johnson & Johnson suspended the sale of several power morcellators manufactured by its subsidiary, Ethicon Inc., pending further guidance from regulators. Court documents indicate that several power morcellator lawsuits now filed in the U.S. involve the company’s products. For example, a case filed on May 13th in the U.S. District Court, Northern District of California blames the Wolf Power Morcellator for the spread of a woman’s cancer cells.
According to the Times, doctors operating within the UPMC network have started using containment bags during hysterectomy and fibroid removal surgeries to limit the spread of cancerous tissue, and are anxiously awaiting an FDA meeting this summer that will discuss the issue further. According to its April alert, the federal agency scheduled a meeting on July 10th with its Obstetrics and Gynecological Devices Panel to decide on the appropriate use for morcellators, and further investigate their risks.
“We will continue to pay close attention to the upcoming FDA panel on the subject and regularly assess the national literature, revising our practices as appropriate,” the UPMC spokeswoman said.
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