Fitzpatrick, Slaughter, Bipartisan Group Release GAO Report on Medical Device Safety
WASHINGTON, D.C. – Congressman Brian Fitzpatrick (PA-08) and Congresswoman Louise Slaughter (NY-25) and a bipartisan group of members have announced the release of a long-awaited Government Accountability Office (GAO) report (attached) into the Food & Drug Administration’s (FDA) approval of power morcellators and the failure of the reporting system to catch this unsafe device.
The report, commissioned in 2015 by Slaughter and former Congressman Mike Fitzpatrick, confirms serious gaps in the FDA’s device reporting process, including:
- FDA identified significant deviations from medical device reporting requirements at certain user facilities – including the failure to establish and maintain medical device reporting files.
- Regarding adverse events specific to power morcellators, the Director of the FDA’s Center for Devices and Radiological Health noted that “while these events appeared to be the kind that would have fallen under the agency’s medical device reporting requirements, the agency did not see the corresponding adverse event reports submitted to the FDA’s adverse event report database.” Additionally, it was noted that this is not unique, and that there is limited to no reporting to FDA or to manufacturers are some hospitals.
- Overall, thirty identified articles published between 1980 and 2012 “mentioned or concluded a risk of tissue dissemination following the use of a power morcellator, or the need for a physician to remove all fragments of tissue following a surgery.” Yet it was not until 2014 the FDA took action after receiving a 2013 adverse event report from a patient.
Fitzpatrick and Slaughter released the following joint statement on the 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.”
Laparoscopic power morcellators are used for hysterectomies and to treat uterine fibroids by grinding, or morcellating, them. However, if the blades hit an undetectable fibroid cancer, it will spread the cancer throughout the body, like shrapnel – taking Stage 1 cancers immediately to Stage 4.
Despite this, no one reported this deadly defect to the FDA, until Amy Reed, a mother of six, and a doctor underwent morcellation and her cancer spread throughout her body. Dr. Reed’s patient report to the FDA was the first adverse event report received by the FDA regarding morcellators, despite her same hospital having has a patient harmed by a morcellator one year earlier. After the initial report from Dr. Reed, hundreds of other safety reports began to flow into the FDA. But it should not have fallen upon the patients to bring this to the FDA’s attention.