The Bleeding Edge, a Netflix Original documentary due to be released on July 27th, highlights four medical devices: Essure, metal-on-metal hip implants, pelvic mesh, and the da Vinci surgical robot. One of these devices, Essure, has changed the course of our lives. Essure has taken us on a path we could have never imagined. From the moment we were “sold” on this medical device, it impacted our families, our finances, and our health.
After we each felt our families were complete, we decided to consult with our physicians about ending our own fertility. What was supposed to be a simple in-and-out office procedure turned into what seems like a lifetime sentence of pain, suffering, and emotional turmoil. Desperate for answers and a remedy, we searched online and stumbled upon the Essure Problems Group on Facebook. It didn’t take long for us to realize we weren’t alone. The group was a haven of support, education and collaboration.
We both decided to become more active in the Facebook group, helping find research and resources to share across the online community. Day in and day out we watched as thousands of women joined and explained eerily similar situations. We listened to women who described everything from immense pain to allergic and autoimmune-type reactions, unexpected pregnancies and pregnancy loss, device perforations, migrations, and hysterectomies, and we even witnessed death among our members. Over the course of a short period of time, we quickly realized we couldn’t just sit idly by and watch the devastation Essure was causing. It became all too clear that manufacturing companies did not have consumers’ health as their first priority. We knew we had to organize to make a change.
We banded together and worked as a team to advocate because the quality of thousands of women’s lives depended on it. We felt compelled to become their voices and eventually we started hitting milestones: our first discovery of corruption and wrongdoing through research; the first doctor who believed us and wanted to help; our first story on the evening news; our first meeting with the FDA; our first conversation with an attorney; and first trips to Washington, D.C. to seek help from our Congressional leaders.
Through our contacts with Congressional leaders we were able to introduce several versions of a bill to help correct the broken system. The current bill in front of Congress is the Medical Device Safety Act of 2017. This bill will restore the litigation rights of all consumers on medical devices that fall under FDA’s premarket approval process.
All of this work was done while we held jobs, cared for our own health, and ran our households. Through these experiences, we received affirmation that it wasn’t just the Essure device risking lives daily. We learned there is a serious problem in this country with how all medical devices are marketed and regulated under the FDA.
Over the course of a short time, it became apparent that the organizations and companies that were in place to help us actually put profits before the health and well-being of patients. This has compelled us and our group to take a stand against a very broken system. We have persisted on our path. While our movement evolved, we beat on every door and wouldn’t stop until Essure was pulled off the market. We know that our most recent milestones, the inclusion of Essure as one of four devices featured in The Bleeding Edge documentary, will serve as a teaching tool so that others can join us and learn to advocate for themselves as well.
Our efforts caused Bayer to announce on July 20th, 2018, just one week before the release of The Bleeding Edge, that it will be halting all sales and distribution of Essure. This announcement was celebrated by thousands of E-Sisters worldwide. All the efforts of the members of the Essure Problems Group paid off! Even though this was a victory, there is still much work to be done. The Medical Device Safety Act of 2017 must be pushed through Congress. Suffering women who have been implanted with Essure still need support to have the coils removed and women still being sold Essure need to be warned about the dangers of this medical device. Bayer needs to be held accountable for harming thousands of women worldwide. Lastly, the FDA needs to understand their current system of approving and monitoring medical devices is not working.
Essure irreparably changed our lives and took us down paths we could have never imagined, from helping form an online support community to becoming patient safety advocates and activists. At some point in our own lives or the lives of our loved ones, we will all likely face the decision of whether or not to use a medical device. We should all be able to trust that they have been tested, approved, and sold to us in good faith. While technology has undoubtedly led to some wonderful life-saving advancements, the profit-driven medical device industry still requires much more regulation, including FDA action when implanted devices cause harm. We can’t always trust that the term “FDA Approved” automatically means a medical device has been proven safe and effective. It is imperative that we all learn to do our own due diligence and research, to be our own advocates, and to make the best informed possible decisions for our healthcare.
To learn more about medical device safety and the E-Sisters’ stories, watch The Bleeding Edge documentary on Netflix on July 27.
The Bleeding Edge trailer - https://www.youtube.com/watch?v=slmilObZl28
Amanda Dykeman is Head Research Coordinator and Administrator of Essure Problems/Vice President of ASHES Nonprofit. Amanda Rusmisell is Legislative Liaison and Administrator of Essure Problems/Secretary of ASHES Nonprofit.