I am writing you today to ask for your attention on a matter that is very personal to me. A medical device called Essure has harmed me, and thousands of other women. Our injuries include, but are not limited to; uterine or fallopian tube perforation, device migration, autoimmune disorders, and extreme reactions to the materials Essure is made of, usually resulting in hysterectomies.
Essure, (founded by Conceptus Inc. out of Mountain View, California but recently purchased by Bayer), is a class III medical device; therefore it is allegedly protected by preemption. As you are probably aware, preemption is a hot topic right now. Patient safety is a national concern. I am reaching out to you as my state representative, to take a stand for me, and thousands of other women that I know injured by Essure, and fight for this unjust law to be changed.
As the law now stands, failure-to-warn and design-defect lawsuits are allegedly preempted for medical devices but not for drugs. This perplexing state of affairs defies all logic. We need to see the courts ruling in Riegel nullified, and make it so the law does not preempt suits against device companies. Patients and physicians deserve to be fully informed about the risks and benefits of medical devices, and the companies making the devices should be held accountable if their product proves to be harming individuals, as is the case with Essure.
Let me briefly explain the Essure procedure. Essure is advertised as follows, “Essure is the most effective permanent birth control available, even more effective than tying your tubes. Essure is hormone-free, surgery-free and there’s no slowing down to recover. You can get back to your family right away.” http://www.essure.com/ A recent study done by the Yale School of Medicine recently disproved this claim. Essure is almost four times less effective than a tubal ligation!
There are two inserts placed into your fallopian tubes during an in office procedure. These inserts are made of a stainless steel inner coil wrapped with PET fibers, which is then wrapped with an outer coil made of nitinol, a nickel titanium alloy. Once inserted, the outer coil is expanded to anchor itself, while the inner coil wrapped with PET fibers elicits an inflammatory response to grow scar tissue, thus blocking the tubes and rendering you sterile. Unfortunately a myriad of problems has been happening in patients. For a deeper look at the problems and to read thousands of personal stories, please visit these sites.
We have a support group on facebook called Essure Problems with over 14,000 women and growing every day. Erin Brockovich has joined our fight and is currently manning a website for us. We are working with an amazing law firm out of Florida, and members of our group have contacted and spoken with several different congressional staff regarding this device and this law. Several newscasts have aired, and more are in the process of being recorded.. Click on the "news" tab on this website to view them. We have written thousands of letters to the FDA and filed multiple adverse event reports, to no avail. They still have not issued a warning to Conceptus (recently acquired by Bayer) about any of the reported problems. Please help us, and all other individuals, that have been harmed by a medical device. The FDA has failed us. We need our elected officials to step up and protect its citizens.
Thank you for your time,