·  Legal News, Analysis, & Commentary


One Step Closer to Justice for Women Harmed by Essure

— November 4, 2015

Rep. Mike Fitzpatrick (R-PA) introduced the E-Free Act, a bill that would remove the dangerous birth control device Essure from the market and strip its maker, Bayer, of pre-emption status. The loss of pre-emption status would allow the tens of thousands of women hurt by this product to sue Bayer.

Today, we are one step closer to justice for women harmed by Essure. Rep. Mike Fitzpatrick introduced HR3920, aka the “E-Free Act.” He was joined by dozens of E-sisters (women who have been harmed by Essure, Bayer’s “permanent” birth control product) at a press conference outside the U.S. Capitol this afternoon.

intro to efa

He said, “Can you imagine such debilitating pain, fatigue and depression that you feel as if your children have lost you as a parent? For women impacted by the medical device Essure and its documented damaging side effects, this unimaginable situation is a stark reality. That’s why, 13 years to the day after Essure was given pre-market approval, I’ve introduced the E-Free Act to remove this device from the market before it can hurt any more women.”

Bayer put forth this vile product, which somehow (money) got pushed through a fast-track FDA approval process that is normally reserved for lifesaving drugs and devices. The Essure coils are comprised of titanium and nickel, as well as PET fibers. PET (polyethylene terephthalate) is a plastic resin that, according to the material safety data sheet (MSDS) of one manufacturer, should not be used for “medical applications involving permanent implantation in the human body.”


The FDA has received over 5,000 formal reports of adverse effects since Essure’s approval, but is only now starting to look at the product’s safety. In the meantime, tens of thousands of women are suffering symptoms ranging from extreme pelvic & abdominal pain, migraines, autoimmune disorders, loss of hair & teeth, fragmentation and migration of the device and organ perforation. Some have even become pregnant, despite Bayer’s claim of near total sterility. Often, those pregnancies result in premature births and even still births as a result of placental abruption (the migrating Essure device causes the placenta to separate from the uterine wall.)

Rep. Fitzpatrick continued, “The failures of Essure are well documented and wide ranging. Yet, in the face of all these facts, this device remains on the market; certified with the FDA’s stamp of approval. That’s unacceptable to me and unacceptable to the tens of thousands of ‘Essure Sisters’ who are living with this device’s effects. If the FDA or manufacturer aren’t willing to act in the best interest of these women, Congress must.”

Representatives of the Essure Problems Facebook group, over 23,000 women who have banded together to help each other, joined Rep. Fitzpatrick in Washington. This group has made amazing strides at the grassroots level toward getting this dangerous product removed from the market.

Amanda Rusmisell, Essure victim and Essure Problems’ Legislative Liaison, said, “The Essure Problems group is so very grateful for the support of Congressman Fitzpatrick. The women harmed represent every party, every nationality, every color, and every walk of life. We have been able to stand side by side and unite and work together for this cause. Tens of thousands of otherwise healthy young women have been significantly harmed by the medical device Essure — most of them requiring multiple surgeries, most often, hysterectomy. We are asking Congress to help push the FDA to revoke the approval for this dangerous and ineffective medical device.”

This is a victory, to be sure. But, the fight isn’t over. Likely, HR3920 will go to committee for review, followed by a vote in the House. If passed, it will face the same process in the Senate before the President can sign it into law.

It is vital that we do not let this issue become “yesterday’s news” until the wrongs have been righted and this product is off the market. Please continue sharing reports of the progress in the fight against Essure. Continue to tell your stories if you’re an E-sister. If you’re a women’s health advocate, take up the banner and join the fight.

It’s not over yet, but you can count on the fact that we will continue to keep this in the public eye until it has been resolved. Too many women have suffered for it to be forgotten.


Fitzpatrick Bill Removes Dangerous Essure Device from Market

Join the conversation!