The alleged problems with power morcellators have gotten as far as the floor of Congress.
The House Committee on Energy and Commerce has begun questioning Johnson & Johnson over allegations that power morcellators may spread cancer throughout the abdomen during certain surgical procedures.
A hearing was held on Nov. 16. During this hearing, the chair of the Subcommittee on Oversight and Investigation began to investigate and question Johnson & Johnson’s practices regarding power morcellators.
Much of the scrutiny has fallen on allegations that alleged power morcellator complications were not properly reported.
In addition to Congress, power morcellators, including ones manufactured by Johnson & Johnson, have fallen under FDA scrutiny. The FDA reported that they had received no adverse reports regarding power morcellators before December of 2013.
However, the various power morcellator lawsuits have alleged power morcellator cancer cases prior to this date.
What are Power Morcellators?
Power morcellators are tools used in a specific type of laparoscopic surgery. Laparoscopic surgery is a form of surgery where the bulk of the operation is performed inside the patient’s body. Laparoscopic surgery allows surgeons to use smaller cuts and cut through less healthy tissue to perform surgery.
But in surgeries like robotic hysterectomies and other surgeries, surgeons have to remove tissues and organs from the body—tissues that may be larger than the small cuts of laparoscopic surgery. This is where power morcellators come in.
Power morcellators work like drills or saws, and cut tissue into smaller pieces for removal during laparoscopic surgery. However, it is alleged that power morcellators may make it easier for cancer to spread throughout the body.
Power morcellator lawsuits alleged that many women who have robotic hysterectomy and related procedures often have cancer cells bound up within otherwise benign tissue, like uterine fibroids. Allegedly, the cutting action of power morcellators may free and spread these cancer cells.
Since how far cancer spreads from its starting point is a major factor in the severity of cancer, this could hypothetically result in a very serious case of cancer. According to an article in the Digital Journal, several women involved in power morcellator lawsuits have passed away from uterine cancer since filing power morcellator lawsuits.
FDA Power Morcellator Warning
Since 2014, the FDA has issued a series of statements warning that power morcellators may spread uterine cancer throughout a patient’s body. In fact, one FDA warning from November 2014, the FDA warned against using power morcellators in most women for hysterectomy and some related procedures due to cancer concerns.
The FDA also strongly urged manufacturers to include warnings to this effect with their power morcellators in the product labels.
The FDA based these warnings on a review of scientific literature, which included data on patients who had robotic hysterectomies and related laparoscopic surgeries from 1980 to 2011. FDA experts estimated the rate of “hidden” cancers and found that one common type of cancer was found in 1 out of every 352 women who had these surgeries.
Another cancer was found in 1 out of every 498 of the same population. Based on this information, the FDA made strong warnings about the use of power morcellators.
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