The Government Accountability Office released a report on Wednesday detailing the complications behind power morcellators, the defective medical device that caused the deaths of at least three women in the Rochester area.
The report reveals the GAO’s investigation about what the FDA, manufacturers and doctors knew about the risk of power morcellators and what they did or did not do to report it’s issues.
Power morcellators are used in uterine fibroids removal surgery to cut tissue so that it can be easily removed through small incisions. The device can spread tissue within the body that may potentially harbor cancer cells.
According to the report, the FDA did not actively look into reports they received in the 1980s that the medical device could spread tissue. The agency did not begin to closely investigate until families began questioning the outcomes of minimally invasive gynecologic surgeries that used power morcellators.
The GAO has been conducting research since February 2016, after members of Congress commissioned the report in 2015.
Rep. Louise Slaughter stated that the report, “shed light on a broken system” and that “immediate congressional action is needed to reform the process and save lives.”
Although the FDA has not yet banned power morcellators, they must come with a warning label.
Read the full article here.