Congressman seeks criminal investigation of medical device harm

by Hooman Noorchashm MD, PhD and Amy J. Reed MD, PhD.

Published Jan. 4, 2016, 12:06 p.m. ET

Just before Christmas, U.S. Rep. Mike Fitzpatrick wrote a letter to the U.S. Food and Drug Administration that could turn up the heat on investigations into a medical device that has harmed thousands of American women.

In this letter, the Bucks County Republican asks the head of the Office of Criminal Investigations at the FDA to look into the deaths related to the use of a medical device known as a "power morcellator".

The request for a criminal investigation is specifically focused on potential wrong doing by prominent hospitals, including Brigham and Women's in Boston and the University of Rochester Medical Center, as well as the largest manufacturer of the power morcellator, Johnson & Johnson.

You can read about these institutions' roles here and here.

Since December 2013, it has become clear that power morcellators can spread and upstage dangerous occult or missed uterine cancers in women. This terrible problem went on for more than 20 years – the epidemiological data suggest that hundreds, if not thousands, of American families have been affected.

But most affected patients did not fully understand what had happened to them - and a majority of gynecologists apparently ignored, failed to recognize or even accepted this collateral damage.

You can read about the dangers of power morcellation here and you can see the faces of the harmed here, here, and here.

It is astonishing that this deadly, but avoidable, complication in women's health was not eliminated by gynecological surgeons long ago. Instead, it was the force of public exposure that ultimately brought this practice to light.

Even now, many decorated gynecologists are continuing to endorse this dangerous practice in women.

Though they had known of the problem for years, these women's health experts did not report it to the FDA.

Now, Congress is getting tuned in, because section 803, Title 21 of the Code of Federal Regulation requires such self-reporting. And it demonstrates that medical device manufacturers and hospitals do not take this law seriously.

The Fitzpatrick letter to the OCI chief is the latest in a series of increasingly visible congressional moves.

Congress has instructed the Government Accountability Office (GAO) to investigate the power morcellator disaster in women's health. This investigation is ongoing.

The chair of the Energy and Commerce subcommittee on Oversight and Investigations, Rep. Tim Murphy, is also looking at this failure.

The FBI is said to be investigating non-compliance with federal regulation leading to the loss of lives related to the use of power morcellators.

Who knew what, when and why was there such a profound failure to warn the FDA or patients for 20 years? We hope these investigations provide the answers.