Essure and Congress: Health priority or political posturing?

by Hooman Noorchashm, M.D., Ph.D. and Amy J. Reed, M.D., Ph.D.

Published Nov. 9, 2015, 2:54 p.m. ET

On Nov. 4, Republican Congressman Mike Fitzpatrick of Pennsylvania's eighth district introduced a women's health bill called E-Free aimed at protecting women from the Essure medical device. You can read about this bill here.

Women across the country who have been harmed by the device contacted Fitzpatrick's office after he sent his senior health aide to the FDA hearing on Essure on Sept. 24. Afterwards, he introduced the bill.

Essure is a nickel-based coil that is placed in the fallopian tubes to achieve sterilization. It is marketed and sold by Bayer HealthCare as a "safe and effective" means of permanent birth control.

You can read more about this medical device and the FDA process governing it here.

The FDA leadership has stated that because the device went through its most stringent safety testing, the chances that it would consider removing it from the market are slim to none. It has said most women who receive the device benefit. Yet thousands of women who have reacted badly to the device – in many cases because of a common nickel allergy -- have seen their health and lives devastated.

When Fitzpatrick learned of this problem with Essure, he acted swiftly. "This is not right,'' he told us, and got to work with his legislative aide, Mr. Justin Rusk.

For Fitzpatrick, Essure is the straw that broke the camel's back in a series of clear safety failures at FDA, which he has been tracking for the past year. Based on our close interactions with this congressman, we can comfortably state that for him, the E-Free bill is about medical device safety and the very serious hazard imposed by this specific medical device.

He first approached the prominent democratic congresswoman Rosa DeLauro, who is a committed advocate for women's health, and who had also expressed a public concern about Essure.

The Connecticut legislator pledged her support to Fitzpatrick and to the Essure women. You can read her "Dear Colleague" letter she wrote to members of congress announcing her support of Fitzpatrick's move here.

DeLauro and her staff met on Capitol Hill with the "Essure Problems" leaders and promised support for the bill. There were apparently warm hugs exchanged and tears shed.

Fitzpatrick drafted the E-Free bill to revoke Essure's FDA approval status, which is legally well within congressional jurisdiction to do. And this move is a courageous and historic one to make. Because congress has never risen to protect America from a specific unsafe medical device.

You can read about the E-Free bill here. You can read the E-Free bill itself here.

What is clear is that Essure has come to be the tipping point for a massive failure in medical device safety regulation at FDA. If 24,000 women from across the country crying "harm" in unison isn't enough to move FDA and Bayer Health into action, the only hope is for the United States Congress to act.

You can read about the 24,000 harmed and their organization, "Essure Problems" here.

But passage of Fitzpatrick's E-Free bill is by no means assured. If Congress revokes Essure's PMA status, this would pose a serious problem for the FDA, for Bayer, and for Planned Parenthood and all medical practitioners that promote it as a "safe" sterilization method.

Still, it was extraordinary that even in these partisan times, the bill enjoyed bipartisan support.

But then on Oct. 30, the day of a planned joint Fitzpatrick/DeLauro press release about the E-Free bill, DeLauro's name did not appear anywhere on it. The release is here.

On Nov. 4, Fitzpatrick stood alone on the steps of the Capitol, surrounded by the "Essure Problems" women from across the country, to announce the E-Free bill.

Why did DeLauro break the promise she had made to thousands of harmed women?

We emailed DeLauro's office to find out. Her press officer responded as follows:

"Congresswoman DeLauro was never an official cosponsor of the bill. She was considering cosponsoring the bill, but ultimately decided to pursue other avenues to address this horrendous issue. There are many reasons she made that decision, one of which was to not set a precedent with legislation that addresses only one medical device. Congresswoman DeLauro believes that the entire medical device process at FDA is flawed and has pushed FDA to review approval for a number of medical devices, including Essure, power morcellators, and duodenoscopes."

But the Essure women are facing a crisis now, and they are not going to go away. They are nearly 24,000-member strong and they are expressing their political fury at DeLauro and the Democratic Party leadership.

Just take a look at Twitter and Facebook, if you want to watch a real political fire-storm brewing.

And while many of the Essure women are committed Democrats, they are now turning for help to Fitzpatrick and the Republican party to get E-Free passed.

Essure critics and many in the GOP share opposition to Planned Parenthood, but whether that's enough of a unifying force to bolster Fitzpatrick's bill remains to be seen.

Already, Fitzpatrick told us, he's heard from Republican colleagues who don't want to get involved in his legislation because "government should not get in the way of the 'free-market'".

Essure harm is real and so are the women and families it has devastated. Preventing harm to thousands more women should be a national health priority, not a point of vacillation and political posturing.