GAO Says FDA Misjudged Risk Associated with Power Morcellator

Posted On February 27th, 2017 By CSSFIRM.COM

MorcellatorThe Government Accountability Office has issued a report stating that the U.S. Food and Drug Administration (FDA) underestimated the harmful effects associated with the laparoscopic power morcellator.

The report, which took 18 months to prepare, was initiated after a dozen members of Congress requested an investigation into the connection between power morcellator surgery and ovarian cancer in 2015. Results of the GAO investigation indicated that the FDA has limitations relating to postmarket surveillance, relying on unprompted reports from manufacturers, medical providers, and patients regarding issues experienced with approved medical devices. Because there were few adverse reports concerning power morcellators until several years ago, issues may have gone unnoticed.

What are Power Morcellators?

Power morcellators are medical devices used during minimally invasive laparoscopic surgeries. Morcellation refers to the cutting of tissue into smaller pieces for removal from the body. In laparoscopic surgical procedures, morcellation allows for the extraction of large pieces of tissue through small incisions.

FDA Recommendations for Morcellation

The FDA considered the risk of spreading an unsuspected cancer through the use of the power morcellator to be relatively low until December 2013, when the agency began to receive adverse event reports concerning the device. However, after receiving reports about the spread of unsuspected cancer following the use of power morcellators in surgeries to treat fibroids, the FDA estimated the cancer risk to women undergoing these types of surgeries was actually about one in 350 and subsequently issued a safety communication in 2014 warning against certain uses of power morcellators, specifically in uterine fibroid surgeries, and recommended that manufacturers add a boxed warning to the morcellator labeling.

The report includes recommendations from professional organizations regarding what the FDA should tell patients about morcellation, but the GAO has no enforcement power, and any procedural changes would have to originate either an executive order from the president or through Congress.

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