The U.S. Government Accountability Office (GAO) has announced that it plans to begin an investigation into power morcellators, the controversial medical devices that shred uterine fibroid tissue for easy removal through laparoscopic incisions. Critics of morcellators say they endanger women’s lives and therefore should be banned because they also spread and worsen hidden cancers.
FDA Warnings Regarding Morcellators – What Took So Long?
In April 2014, the U.S. Food and Drug Administration (FDA) issued a warning against using power morcellators for hysterectomies and myomectomies in most women with uterine fibroids because of the risk of spreading undetected cancer present in 1 of every 350 women undergoing these procedures. In October 2014, the FDA ordered that a Black Box warning be added to morcellators.
Last month, 12 congressmen sent a letter to the GAO, asking the agency to investigate why the FDA took so long to issue these warnings, given that morcellators have been on the market since 1991 and numerous studies have established the high risk they pose for spreading uterine cancer. The lawmakers are also questioning whether the expedited 510(k) approval process used by the FDA to clear the power morcellator missed the cancer risk of the device before it was approved. The FDA has said that the magnitude of the risk associated with morcellation wasn’t known until the issue came to light in late 2013, when the agency began researching how the devices could harm women.
Morcellators Falling Out of Favor, But Still Used
Since the FDA issued that first warning about power morcellators in 2014, use of the device has fallen, and one manufacturer, Johnson & Johnson, voluntarily pulled its morcellators off the market. Many major insurers have either dropped or restricted coverage of procedures involving morcellation, and as a result, fewer surgeons are using the devices. The power morcellator is blamed for hundreds of deaths and is the subject of numerous lawsuits pending across the U.S.