Congressman Wants Criminal Investigation of Morcellator Deaths

Congressman Michael Fitzpatrick (R-PA) is seeking a criminal inquiry into deaths associated with the use of power morcellators, a controversial device that can unwittingly spread cancer in women who had uterine fibroids removed or hysterectomies performed.

Brian Buntz

In a letter to FDA's Office of Criminal Investigations, Michael Fitzpatrick, representative of the eighth district of Pennsylvania, alleges that hundreds or even thousands of women have died as a result of being treated by power morcellators despite initial FDA guidance that the cancer risk associated with the device was relatively low.

The agency now believes that the device could spread cancer in as many as 1 in 352 cases, ultimately leading FDA to issue warnings related to the device in 2014, recommending that the morcellators not be used in most patients. (Some gynecologists apparently disagree, insisting that the devices are safe when proper patient selection criteria is followed.)

Congressman Fitzpatrick is specifically asking for an investigation of the formerly most prominent maker of morcellators, Ethicon, a subsidiary of Johnson & Johnson, as well as prominent hospitals that had used the devices extensively such as Brigham and Women's in Boston and the University of Rochester Medical Center. The letter specifically mentions three women who likely died from cancer upstaged by the device. It also questions whether those deaths were properly reported to the FDA. (Ethicon halted sales of its morcellators in 2014).

Though the devices have been in use for more than two decades, FDA stated in a November 12, 2015 letter to a Fitzpatrick that, prior to late 2013, it did not "receive any adverse reports related to the spread or upstaging of unsuspected cancer through morcellation of uterine tissues."

The first report of a cancer being spread via morcellators did not come from a device maker but rather from a physician whose wife had been treated with the device.

Although FDA did not release a warning about the devices until 2014, in 2006, however, Ethicon amended the label for its Gynecare Morcellex tissue morcellator to warn that the device "may lead to dissemination of malignant tissue."  

In August, 2015, Rep. Mike Fitzpatrick, Rep. Louise Slaughter (D-NY), and a bipartisan group of lawmakers sent a separate letter to the U.S. Government Accountability Office, asking the GAO to scrutinize what criteria FDA used to clear morcellators and whether medical device reporting regulations are being followed appropriately.

A few months earlier, in May of last year, the Wall Street Journal reported that the FBI was investigating Johnson & Johnson officials to determine what they knew about the devices' potential to spread cancer.

Fitzpatrick has been aggressive in seeking to curtail the use of medical devices he believes are unsafe. Last year, he introduced the E-Free Act that would require FDA to withdraw approval for Bayer's Essure contraceptive.   

Last year, Fitzpatrick also worked to have an amendment added to the 21st Century Cures Act, recommending that "unique device identifiers" be included in electronic health records to help improve the tracking of device-related adverse events.

Brian Buntz is the editor-in-chief of MPMN and Qmed. Follow him on Twitter at @brian_buntz.

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