Congressman Seeks Criminal Inquiry into Morcellator DeathsJan 7, 2016
Pennsylvania Congressman Michael Fitzpatrick is calling on the U.S. Food and Drug Administration's (FDA's) Office of Criminal Investigations to investigate three deaths associated with the use of power morcellators, Qmed reports. Morcellators are surgical tools that are used during laparoscopic surgery; they mince up tissue into smaller pieces so surgeons can remove it more easily through small incisions. In 2014, however, the FDA warned that use of morcellators during gynecologic procedure could inadvertently spread cancerous tissue. The issue has led to debates about what recommendations to make and whether the instrument should be banned.
The FDA has warned that morcellators should not be used in most patients. The agency said the risk of spreading a hidden cancer masking as a uterine fibroid was 1 in 352. The most prominent manufacturers of morcellators is Ethicon, a subsidiary of Johnson & Johnson.
Congressman Fitzpatrick is requesting a probe of Ethicon and hospitals include Brigham and Women's in Boston and the University of Rochester Medical Center. He alleges that hundreds or perhaps even thousands of women have died due to morcellator use, even though the FDA initially warned that the risk of spreading cancer was fairly low. His letter discusses three women who died of cancer likely related to use of the device. Fitzpatrick also raises concerns over whether their deaths were properly reported to the FDA. The agency told him in November that it did not “receive any adverse reports related to the spread or upstaging of unsuspected cancer through morcellation of uterine tissues."
Fitzpatrick was part of a group of bipartisan lawmakers who sent a letter to the U.S. Government Accountability Office in August 2015. The letter called on the GAO to analyze the details of how morcellators were approved.