Feds Investigate Power Morcellators
A government investigation has been opened into power morcellators which have been linked to the spread of undiagnosed cancers in women.
About the Power Morcellator Health Risk
Medscape Medical News reports that the power morcellators which are used to break up uterine fibroids allowing for easy removal through laparoscopic incisions. However, research has found that use of such devices can also result in the spread of uterine cancer.
Recent data suggests that nearly 1 in every 350 women who have undergone power morcellation procedures developed a higher risk of cancer.
The FDA ordered the products carry updated labels six months after this discovery. As such, power morcellators are for the most part contraindicated for hysterectomies or myomectomies in women with uterine fibroids.
Despite the new warning, the FDA has been criticized for what has been perceived as a slow response. The devices have been used since 1991 and they just recently issued the proper warnings in 2014.
Details of the Federal Investigation
- In August, 12 members of Congress asked the U.S. Government Accountability Office (GAO) to investigate why the FDA warnings were not issued sooner.
- According to the request, studies had long suggested that use of power morcellators procedures carried a high risk of spreading uterine cancer. Further, lawmakers are questioning whether the cancer risk would have been acknowledged had the devices not been approved through the FDA’s expedited 510(k) process
- The lawmakers pressing for the investigations believe the devices are directly responsible for hundreds, if not thousands, of deaths.