‘Passive’ FDA reporting system to blame for dangerous surgical tool staying in use

A Government Accountability Office (GAO) report says physicians and hospitals failed to tell the Food and Drug Administration (FDA) of safety issues related to power morcellators spreading undiagnosed cancer cells in women.

Those devices aim to make tissue removal easier through small incisions and are most often used during hysterectomies or to remove benign uterine tumors. In 2013, they were being used in at least 50,000 procedures annually when the FDA got its first formal report of morcellation spreading malignant cells around the abdomen and “upstaging” the disease to a more advanced cancer.

The FDA had known about the devices' risk for spreading tissue since they were first approved in 1991. The GAO report said all available clinical information until 2013 indicated “the risk of a woman undergoing treatment for fibroids having unsuspected cancer—specifically, a difficult to diagnose cancer called uterine sarcoma—was low. Therefore, the risk of a power morcellator spreading a uterine sarcoma would be expected to be low.”

Once the first report came, hundreds more followed, with 88 percent of the 258 reports the FDA has received on the subject since December 2013 having been mandatory reports from device manufacturers. The issue, according to the GAO report, is the FDA relies on doctors, hospital and device companies to report “adverse events,” and may only consider failures of the device to fall under that definition.

“For power morcellators, officials from three healthcare 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 (for example, cutting and extracting tissue),” the report said.

A bill in the last Congress aimed to change this passive reporting system to an active one by requiring physicians and their practices to report defects or issues with devices, while protecting doctors from being sued over those reports. One of the sponsors of that legislation, Rep. Louise Slaughter, D-New York, said she plans on introducing another bill to follow up on the report’s recommendations.

“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,” Slaughter said in a joint statement with Rep. Brian Fitzpatrick, R-Pennyslvania. “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.”