Flawed Reporting System Kept FDA in the Dark on Cancer-Spreading Surgical Device
Uterine cancers disseminated by surgical device.
A cancer-spreading surgical device was used for more than 2 decades due to the lack of data reported to the FDA on the device’s risks by physicians and hospitals, according to a new report by the Government Accountability Office.
The first laparoscopic power morcellator came onto market in 1991, and was approved by the FDA for use in minimally invasive gynecological surgeries, which included the removal of fibroids. The device cuts tissues into pieces small enough that they could be removed through a small incision.
Some women with fibroids have undiagnosed cancers, however, and morcellation can spread the malignant cells around the body like seeds, causing the disease to advance to a deadlier form, according to The New York Times.
It was not until 2013 that the FDA worked to limit the device, after receiving the first alert of the problem from patients.
Prior to 2013, the FDA had not received any reports of uterine cancers being disseminated by morcellators, according to the NY Times. But following media coverage of the 2013 case, reports began to pour in, totaling 285 by September 2016. Furthermore, some of the women reportedly died.
In the United States, the device was used on at least 50,000 women per year to help remove fibroids or the entire uterus, according to the NY Times.
In November 2014, the FDA issued a safety communication warning against certain uses of power morcellators—–specifically in treating uterine fibroids. Furthermore, the agency issued guidance recommending that manufacturers add a boxed warning to their device labeling, which all current manufacturers followed, and conducted inspections to review hospitals’ compliance with medical device reporting requirements.
The government report stated that a major flaw in the system for detecting harm from drugs and devices was that it was too passive, relying on adverse event reports to the FDA from physicians, hospitals, drug and equipment manufacturers, and consumers.
However, physicians and hospital officials told investigators that before November 2014—–when the FDA stated that cancer spread after morcellation was an adverse event that had to be reported––they would not have regarded it in that way, nor reported it, according to the NY Times. In fact, they believed that adverse events from surgical devices were mainly related to failures in the device itself, and that in the cancer cases, the morcellators were doing precisely what they were designed to do in cutting up the tissue, the report noted.
The FDA released a written statement citing their agreement with the findings of the government report.
“The FDA has noted the shortcomings of the current passive postmarket surveillance system and has been taking steps to establish a better system to evaluate device performance in clinical practice,” the FDA wrote.
The FDA was aware of the possibility that the morcellators could spew hidden tumors, but the risk was believed to be small, with 1 in 500 to 1 in 10,000 women who had fibroids also having undetected cancer, according to the NY Times. However, subsequent research shows that the risk was greater with approximately 1 in 350.