FDA approved several risky surgical devices: GAO report
An investigative government report has revealed that the U.S. Food & Drug Administration (FDA) approved more than two dozen surgical devices over a period of two decades that could spread undiagnosed cancer in women’s bodies.
In its report released on Wednesday, the U.S. Government Accountability Office (GAO) said that those devices (tissue-cutting tools known as power morcellators) were deemed so alike to older devices for knee and other joint surgeries that they were approved for gynecologic surgeries without meticulous testing.
The GAO concluded that the FDA knew that the newer devices could accidentally spread a uterine cancer, but didn’t warn doctors and patients, considering the risk was too low.
The federal agency launched an investigation into the matter in late 2013, after married doctors Hooman Noorchashm and Amy Reed of Philadelphia launched a campaign to ban electric morcellators.
Commenting on the GAO report, Noorchashm said yesterday, “This GAO report is de facto confirmation that hundreds, if not thousands, of American women have been harmed or died because of this regulatory failure and the failure of the reporting system.”
A morcellator spread Dr. Reed's undetected uterine cancer during a hysterectomy in 2013. In spite of aggressive treatment, she is still battling leiomyosarcoma that has spread to her numerous organs.
In 2014, the FDA acknowledged the deadly risk and warned that the devices could spread or worsen uterine cancer, estimating that 1 in every 350 female patients who undergo a fibroid surgery or hysterectomy could be at risk. The federal agency underlined that the devices shouldn’t be used in majority of cases.
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