Morcellator Cancer Risk Controversy Highlights Weak Reporting System: GAO
A recent government report highlights problems with the FDA’s adverse event reporting system, which it says led to a slow response to signs that a medical device known as a power morcellator was spreading aggressive cancers among women undergoing laparoscopic hysterectomies and procedures to remove uterine fibroids.
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.
The U.S. Government Accountability Office (GAO) released a report on February 8, analyzing the FDA’s response to power morcellator cancer risks. The report found that a lack of data led the FDA to likely underestimate the risk that morcellators were spreading uterine cancer among many women, with 25 devices approved before the problems were detected.
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.
However, prior to December 2013, the FDA had estimated the risk of a woman having undiagnosed sarcoma and undergoing power morcellation at about 1-in-1,000. It later revised those estimates to about 1-in-350. The report suggests that doctors did not file adverse event reports when cancer was spread, because they knew it was a risk, but thought it was a much rarer incident than was later discovered. Had doctors and hospitals reported the cancer incidents, the FDA might have known there was a problem sooner, the report suggests.
“According to FDA officials, of the 285 adverse event reports regarding power morcellators and the spread of unsuspected cancer that the agency received through September 2016, 5 were related to events occurring after FDA issued its guidance and updated safety communication in November 2014,” the report states. “FDA officials noted, however, the limitations in the current, passive, medical device reporting system, which relies on people to identify that a harm occurred or a risk is present, recognize that the harm or risk is associated with the use of a particular device, and take the time to report it. For power morcellators, officials from three health care providers (two hospitals and one physician group) that we spoke to stated that prior to November 2014, physicians would likely not have considered the spreading of an unsuspected cancer following the use of a power morcellator as a reportable adverse event, because the device would have performed as intended (e.g., cutting and extracting tissue).”
Since warnings were first issued by federal regulators in April 2014, the medical community has largely abandoned the use of morcellators, and Johnson & Johnson’s Ethicon unit, which was previously the main manufacturer of the device, stopped selling the tool.
The GAO report comes just days after another FDA-funded study suggested that a system of active surveillance would help to better detect problems linked to medical devices than the current voluntary reporting system.
According to the study, the FDA has made a priority of the evaluation and implementation of a system that would continuously monitor large clinical data sources, instead of relying on voluntary reporting.
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 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 morcellator risks.