According to GAO Report, FDA Delayed Power Morcellator Warning
Posted on behalf of Gordon & Partners on Mar 01, 2017 in Defective Products
Between 1991 and 2014, the U.S. Food and Drug Administration (FDA) approved 25 surgical power morcellator devices that could spread undetected uterine cancer in women, according to a report from the Government Accountability Office (GAO).
The defective medical devices, which are used in minimally invasive laparoscopic surgeries to cut up tissue so it can be removed through a small incision, were approved by the FDA's 510(k) program in 1991. The controversial program allows for speedy approval of new devices that are substantially similar to others already on the market without rigorous testing and clinical studies.
The FDA first began receiving reports that power morcellators could spread undetected cancer during surgical treatment of women with uterine fibroids in 2013.
The report noted that, at the time, the FDA was aware that power morcellators could spread undetected cancer, but believed the risk to be too low to warn doctors and patients.
Additionally, the report claims that gaps in the FDA's system for reporting injuries and deaths caused by medical devices meant that doctors and hospitals either did not report the problems to the FDA or the health regulator did not see them.
It was not until 2014, that the FDA issued a safety communication warning against certain uses of power morcellators. It estimated that the risk for spreading undetected cancer was approximately one in 350.
Because of this it warned against using power morcellators in most cases and required a black box warning be added to the device's warning label, which is the highest warning level.
Several women throughout the country have filed power morcellators lawsuits after developing cancer from a surgery in which this defective device was used.
If you were diagnosed with cancer following a hysterectomy or uterine fibroid removal where a power morcellator was used, you may have legal options. The defective medical device lawyers at Gordon & Partners will fight to hold negligent manufacturers accountable for the harm their products have caused. We will work to recover compensation for your medical bills, lost wages, and pain and suffering.