Pennsylvania Republican U.S. Rep. Mike Fitzpatrick has called for an investigation into the safety regulations of power morcellators, surgical tools used in the treatment of uterine fibroids and hysterectomies that have been linked to spreading upstaged uterine cancer. The Congressman’s plea follows a letter he sent in December 2015 to the FDA asking for...
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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...
Feds Launch Investigation into Morcellator Safety Regulations
According to The Wall Street Journal , the U.S. Government Accountability Office (“GAO”) is officially stepping in to investigate the controversial power morcellator medical tool. The investigation was prompted by a dozen lawmakers who wrote to the GAO in August 2015 urging a probe into laparoscopic power morcellators and the regulatory process used...