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What happened with Essure?

If there is a story that best illustrates how severely the medical system can fail women, it’s Essure. Billed as a permanent birth control device, even the description of how it works is terrifying: Metal coils implanted in the fallopian tubes, which then cause enough scar tissue buildup to prevent ovulation. Sounds scary, and, surgically, it goes against a golden rule: Don’t put something in if you can’t get it out. Eg, that scar tissue buildup? It means Essure probably can’t be removed without a hysterectomy, most often requiring a full hysterectomy to remove the device. We repeat: a full hysterectomy, a complete removal of the uterus if not fallopian tubes and ovaries as well! You know, bodily organs that play a pretty big role in women’s lifelong hormone regulation and immunity, let alone fertility.  It’s a pretty twisted fate when a big selling point for the device was that it could be implanted so easily, “just takes 15 minutes in your doctor’s office!”–little did we know. With Essure, women often seemed to end up with  debilitating auto-immune disorders or in some cases, “migration” of the device that resulted in the “puncturation” of other organs and other potentially severe complications. And, ya know, to get the thing removed women needed a hysterectomy. It’s terrifying and nauseating to think about – but what happened next is pretty incredible.

Enough women started speaking up, reporting their symptoms to their doctors and to the FDA Drugwatch website, that the FDA took notice. First came the FDA Black Box Warning on the device – which is the most stringent warning the FDA can put on any drug or device, to indicate the potential for severe side effects or death – and then finally they removed Essure from the market at the end of 2018. This is a big deal and a huge win for patient advocates! We love the documentary “The Bleeding Edge” that talks about this process and the fight women and their doctors went through to make this happen!

However — that wasn’t quite enough. Women were overjoyed the device was off the market and no longer harming women, but that wasn’t enough to compensate for the women who were still suffering from related side effects, losing work or time with their families and children, or fighting for their own health and energy every day.

ACFW was founded near the beginning of the Essure litigation in 2015. Susan and Jordan, our mother-daughter co-founders, were on a mission to provide free and equal legal access to women across the country – and when they learned about Essure, knew we had to jump in. Over the four years that the team at A Case for Women worked on Essure, we encountered countless stories from women who were hurt, angry and wanted change. We talked to women who had experienced early hysterectomies and subsequently faced menopause in their 20s or 30s. Women who had hidden their birth control choices from their family and were forced to share private decisions due to the medical issues they were facing. Women who lost time with their young children while fighting debilitating, painful side effects. We connected thousands of women with law firms who were willing to take on their cases on contingency only. These firms, in turn, fought for these women for years, fronting all of this cost themselves and taking a huge risk since they’d only ever be paid back for their efforts if they were successful in winning a successful verdict or settlement against the drug company. The women involved never paid a dime out of their own pockets — they had been through enough.

During this time hundreds of women who were unable to find the time or money to have the device removed, yet were still suffering side effects. Many firms were unable to take these women’s cases on at first, but late in the litigation process, these women’s voices reached a critical mass, and there was more research into the ways in which women could have been hurt by the device. When all this added up, they were able to send hundreds of previously unrepresented women into the fight!

In the last months of the Essure litigation, our team barely slept for weeks. We worked around the clock contacting women who were about to run out of time to join the fight. We wanted to make sure every last woman in the country knew their options, so that no one would see the news about settlement and call us wondering why it was too late to sign up. Unfortunately, we do still get some of those phone calls, and it breaks our heart. But it also reminds us why we do what we do – we want women to know their legal options and to have equal access to law firms. There should not be a huge knowledge or price barrier to taking legal action in this country – and that is why we do what we do.

And now?

Almost all of the Essure cases are settled. Those women and lawyers who went to bat for them for years WON their cases. Essure is off the market, and women injured by Essure birth control received individual settlements of approximately $45,000 before attorneys fees and expenses were deducted.This settlement was announced in August of 2020 as part of a $1.6 billion payout by Bayer. In the words of every drug company around: Ouch! Better take women’s bodies and wellbeing seriously next time. 

So what’s next?

While we are grateful that this product was taken off the market, we are still angry that women’s health is consistently an afterthought, particularly women’s reproductive health. The fact is, there aren’t enough good, safe options for birth control for women, and that makes us furious. The more we can push on the manufacturers and the FDA with these cases, the more we can create bigger picture change. A world where there’s more testing, more know-how about how women’s bodies differ from men’s, and a whole lot of better, safer options for women of all ages.

Our eyes are now on Paragard, a copper IUD. Manufacturers and the FDA approved to last for an additional 5 years. However, they didn’t make upgrades to the plastic in the device, or perform and publish sufficient testing about its durability for the full 10 years they approved. Women are suffering device breakage and ending up with fertility issues and other potentially severe side effects, and we are NOT HAPPY ABOUT IT. We anticipate that these potential cases will take a very similar path to Essure. Although we can’t predict the course of the litigation as it is so early on, we believe that if you join the fight now, there is the potential for a similar payout to the Essure cases – and your voice will be added to the thousands of women who have had enough! If that sounds like you – reach out to us here. Likewise, if you are suffering from side effects from another device not on our radar, let us know here.