GAO flags gaps in FDA’s adverse event system in power morcellator report

Limitations in the FDA’s adverse event reporting system for medical devices helped allow the widespread use of laparoscopic power morcellators for years before the risk that they can spread cancer became known, a government watchdog said this week.

Medical device manufacturers and importers are required to tell the FDA about any device-related adverse events within 30 days. “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,” the Government Accountability Office found in its report.

Power morcellators, 1st cleared for the U.S. market in 1991, are designed to shred benign uterine tissue using small, rotating blades. But if the patient has an undiagnosed cancer called uterine sarcoma, the malignant cells are strewn throughout the abdominal cavity along with the benign morcellated tissue. The FDA estimates that women undergoing hysterectomies or myomectomies with the devices 1-in-350 odds of having an undetected cancer.

The FDA didn’t receive its 1st adverse event report on the link between power morcellators and cancer until December 2013, meaning that power morcellators were used for nearly 23 years. And although the cancer incidences were the type that usually would trigger an adverse event report, “the agency did not see corresponding adverse event reports submitted to FDA’s adverse event report database,” according to Dr. Jeffrey Shuren, director of the FDA’s Center for Devices & Radiological Health.

In part that’s because the healthcare providers didn’t consider the cancers to be device-related, GAO investigators found.

“For power morcellators, officials from 3 healthcare providers (2 hospitals and 1 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),” according to the GAO’s Feb. 7 report.

The FDA inspected 5 of the hospitals with adverse events related to the spread of uterine cancer from the use of power morcellators. Shuren said another problem is that hospitals just don’t report adverse events or even have procedures in place for making the reports, according to the GAO.

“Based on the number of user facilities in the U.S. and the number of reports FDA receives, the agency believes that these hospitals are not unique, in that there is limited to no reporting to FDA or to the manufacturers at some hospitals,” according to the report.

Another problem is that hospital staff “often were not aware of nor trained to comply with all of FDA’s medical reporting requirements,” Shuren told the GAO, according to the report.

The FDA cleared 25 laparoscopic power morcellators between 1991 and 2014 via its 510(k) protocol, determining that all had the same intended use as their predicate device: An electromechanical system for cutting tissue during joint arthroscopies the federal safety watchdog deemed in 1978 to be substantially equivalent to an even older technology, the GAO reported.

The government oversight body launched its investigation late last year, prompted by a request from 12 members of Congress led by Reps. Louise Slaughter (D-N.Y.) and Mike Fitzpatrick (R-Pa.). This week Slaughter and Rep. Brian Fitzpatrick (R-Pa.), who succeeded his brother after Mike Fitzpatrick retired last year, hailed the GAO report.

“The release of this long-awaited report won’t do anything to help women battling cancer who have had their lives devastated by power morcellators, or provide much comfort to the families of those already lost. It does, however, shed light on the broken system that allowed this devastation to happen and include a roadmap to address it. The GAO report confirms what we had long expected: There are serious gaps in the FDA’s device reporting system and that immediate Congressional action is needed to reform the process and save lives. Additionally, given the associated risks, it’s clear that this device is no longer appropriate in the treatment of uterine fibroids. Armed with this information, we will move forward to find bipartisan legislative solutions to address these shortcomings and ensure a system is in place that provides real, accurate information to patients, professionals and regulators,” Slaughter and Brian Fitzpatrick said in prepared remarks.

In July 2014, Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon Endo-Surgery voluntarily asked for the return of its laparoscopic power morcellators used in fibroid surgeries, a few months after it suspended sales of the devices on FDA warnings of the cancer risk. Earlier in July an FDA panel failed to come to a clear decision on the cancer risk from laparoscopic power morcellators, despite outraged testimony from dozens of attendees.

A year later an FDA panel convened to consider the use of power morcellators in fibroid removal in hopes of coming to a clear decision on the cancer risk from the devices, despite outraged testimony from dozens of attendees. By November 2015 the FDA had slapped a “black box” warning on the labeling for power morcellators, advising physicians of the cancer risk.

And in November 2016 the agency cleared the PK morcellator made by Olympus (TYO:7733), which is designed to contain morcellated tissue.

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