FDA’s 510(k) Approval of Morcellators under U.S. GAO Investigation

As more laparoscopic power morcellators lawsuits are being filed, the devices have come under more intense scrutiny, with the U.S. Government Accountability Office stepping in to monitor the regulatory process.  Morcellators are surgical devices used during gynecological procedures for the removal of fibroids; however, they have recently been linked to spreading aggressive, deadly uterine cancer, calling into question the safety of the tools. Morcellators were approved via the FDA’s 510(k) approval process, which allows manufacturers of surgical tools to hasten the device’s approval by demonstrating that it is substantially equivalent to a device already approved by the regulatory agency. Many are now wondering if this was a mistake, as the FDA estimated in April 2014 that 1 in 350 women who undergo morcellation to treat uterine fibroids also have undiagnosed uterine sarcoma.

Attorneys at Grant & Eisenhofer are investigating these claims and are litigating against device manufacturers on behalf of women who developed uterine cancer after undergoing morcellation. If you or a loved one were diagnosed with cancer after having a hysterectomy or myomectomy for the treatment of fibroids, please contact us by calling 884-351-2395 to discuss your potential claim and your legal options.