FDA Advises Manufacturers of Power Morcellators to Use Black Box Warning

The FDA has taken action this week to eliminate the use of laparoscopic power morcellators during hysterectomies. The agency is now imposing a black box warning on manufacturers of the surgical tool, which has been widely used since the 1990s to remove fibroids. Foregoing the normal comment period that usually accompanies a black box warning recommendation, the FDA has exercised its authority to call for an immediate use of the warning.

Although the agency has no power to regulate the actions of health care providers and their practices, the black box warning could potentially make medical practices the target of lawsuits that assert the FDA’s claim that morcellators can actually spread undetected cancer. 

In response to the FDA’s advisory, Johnson & Johnson, the largest manufacturer of morcellators, has suspended sales altogether according to a Reuters reports.

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