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A recent review by federal regulators not only appears to confirm the risk of spreading uterine cancer cells through the use of power morcellators during laparoscopic hysterectomy and uterine fibroid removal procedures, but also indicates that the danger may be higher than previously believed.
The FDA announced new findings in a press release issued on December 14 , indicating that the agency now believes there is as high as a 1-in-225 risk that a woman undergoing laparoscopic morcellation will have contained cancer cells hidden in her uterus spread to other parts of her body, where they could metastasize, resulting in aggressive cancers such as uterine sarcoma, or leiomyosarcoma. Previous estimates by the agency placed the chances first at 1-in-1,000, which was upgraded to 1-in-350 in 2013.
Morcellators became widely used over the past decade, allowing doctors to cut up and remove the uterus and uterine fibroids through a small incision in the abdomen. The minimally invasive procedures were recommended as a way to limit the risk of surgical complications and reduce recovery time. However, use of the devices has largely been abandoned, since the medical community discovered that morcellators may spread undiagnosed cancer cells contained within the uterus, leading to the rapid upstaging of leiomyosarcoma, endometrial stromal sarcoma and other difficult to treat cancers.
In November 2014, the FDA decided to add a black box warning to power morcellators about the cancer risk, and provided guidance on the limited instances where laparoscopic hysterectomies may be warranted.
“Since the FDA first issued warnings about the risk of spreading unsuspected uterine cancer from the use of laparoscopic power morcellators, we have continued to review new research to ensure our recommendations reflect the most current scientific evidence. Our latest analysis found a similar incidence of these hidden cancers to our estimate three years ago,” Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in the press release. “We recognize that some health organizations have reported a lower estimate of risk and that some groups continue to request that we scale back our recommendations. However, after looking at all the relevant data, we believe our estimates remain accurate, and our recommendation against the use of this device to remove fibroids in the vast majority of women is appropriate and critical to better protecting these women.”
The agency’s findings were detailed in a white paper (PDF) published along with the press release.
In addition to the morcellation uterine cancer risk numbers, the agency also found evidence that there are differences in patient outcomes and chances of survival between women with uterine cancers based on whether they did or did not undergo morcellation. Their findings suggest there is a higher risk of cancer death among women who underwent power morcellation, when compared to women who had sarcomas but did not undergo the procedure.
The press release indicates that the FDA is continuing to study the link between morcellation and cancer, and is encouraging surgeons to limit use of the devices.
“The FDA continues to believe the use of power morcellators to remove uterine fibroids should be limited to a small number of women, typically young women who wish to bear children and otherwise could not without use of a morcellator, and who choose this option after being informed of the risks,” the press release states.
Johnson & Johnson has faced dozens of morcellation cancer lawsuits brought on behalf of women who suffered problems after a laparoscopic procedure, and wrongful death claims by family members of women who had died of such cancers.
While most of those cases have been resolved through morcellator settlement agreements, a number of other morcellator manufacturers continue to face claims alleging that they failed to warn the medical community about the cancer risks.