FDA knew that laparoscopic power morcellators could potentially spread cancer when the agency approved the device, though the agency believed that risk was low, according to a Government Accountability Office (GAO) report released Wednesday.
Background: GAO launches investigation into morcellators
FDA approved laparoscopic power morcellators in 1991 as an alternative to invasive surgery for women with symptomatic uterine fibroids, which are benign tumors that are responsible for about 40 percent of the 500,000 hysterectomies performed in the United States each year. Until recently, the device was used in about 50,000 procedures annually in the country.
Laparoscopic power morcellation came under fire for their potential to spread a certain type of cancer—known as a uterine sarcoma—within the body. A study published in JAMA in 2014 estimated that one in 368 women undergoing morcellation had uterine cancer that was undetected until after the procedure.
In November 2014, FDA called for an immediate "black box" warning for laparoscopic power morcellators. The black box warning is the strongest warning that the agency issues. However, it falls short of issuing a market-wide recall of the devices, for which some opponents of the tool had called.
Many hospitals and large insurers have either scaled back their use or coverage of the devices or are considering setting limits.
In 2015, GAO confirmed it would investigate the tool, following a request from a bipartisan group of lawmakers.
Report finds FDA underestimated risk of morcellators spreading cancer
GAO in the report said FDA was aware of the risk laparoscopic power morcellators presented for spreading malignant cancers, known as sarcomas, when the agency approved the device in 1991, adding that the risk was highlighted in several medical journal articles dating back to the 1980s.
Why one insurer will keep covering a controversial surgery tool
According to GAO, FDA at the time it approved the device had believed the risk of spreading sarcomas was low. GAO stated that FDA officials had estimated that one in every 1,000 to 10,000 women receiving fibroid surgery also had uterine sarcoma.
GAO reported that FDA in 2014 estimated that one in 350 women having fibroid surgery also have uterine sarcoma—an estimate considerably higher than when FDA had approved the device. GAO stated that FDA officials said there was not a consensus about morcellators' risk of spreading hidden cancers before the agency started investigating the issue.
However, GAO stated that a 2012 study had cited a hidden cancer rate that was "9 times higher than the rate quoted to patients at the time" the device was approved. GAO also found 29 additional medical articles noting the risk morcellators presented for spreading harmful tissue.
Report points to issue with FDA's adverse event reporting system
GAO in the report also highlighted an issue with FDA's system for receiving adverse event reports, the New York Times reports.
Report: FDA failed to track many drug safety issues
GAO found that FDA had received no reports of morcellators spreading uterine cancer before 2013. However, health care providers and others filed 285 adverse event reports on the matter between 2013, when the issue first gained widespread attention, and September 2016.
According to the Times, the GAO report indicates that FDA's system for detecting issues with drugs and medical devices is "passive" because it relies on manufacturers, patients, and providers to report them. Medical providers told GAO investigators that they would not have considered the spread of cancer after morcellation until FDA in November 2014 explicitly said it was an adverse event that should be reported. Providers said they had thought they only should report adverse events related to whether the devices was able to perform its intended function of slicing tissue.
FDA, lawmakers react
An FDA spokesperson said the agency has reviewed the GAO report and agrees with the findings. The spokesperson said 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."
Reps. Brian Fitzpatrick (R-Pa.) and Louise Slaughter (D-N.Y.) in a statement said the report "shed light" on a "broken system" and called for "immediate congressional action ... to reform the [adverse event reporting] process and save lives" (Levitz/Kamp, Wall Street Journal, 2/8; Grady, New York Times, 2/8; Singer, Rochester Democrat & Chronicle/USA Today, 2/8; Fitzpatrick/Slaughter statement, 2/8).
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