The year was 2002 and Conceptus Inc announced the FDA approval of a new permanent birth control procedure called Essure.
Small coils, made of a flexible Nickel-Titanium-Steel alloy, appearing much like a small spring wound around fibers made of PET (polyethylene terephthalate) fibers. The spring would hold the device in place at the junction of the uterus and fallopian tube. The polyester fibers would create local inflammation and create a tubal blockage over the course of a few months.
The medical community welcomed this product and trusted that the FDA approval was adequate in its safety assessment of this device.
Doctors around the world began placing these devices in patients desiring permanent contraception.
Years went by.
Essure Complications Get National Attention
Erin Brockovich, a consumer advocate who had a blockbuster movie made about her (played by Julia Roberts), took a special interest in Essure after hearing that women were surfacing with Essure related complications.
Thanks to social media and the internet, the word got out. Many women shared their stories, documenting a long list of medical complications associated with Essure. Most recently, the Netflix Documentary “The Bleeding Edge” exposed the lack of FDA oversite and widespread issues women have been facing since the release of Essure.
So what happened?
What We Know About Essure Problems
At this juncture, we are certain of a few things.
For one, Bayer Pharmaceuticals, the company that acquired Essure, has pulled the device from the market. The company claims this is a financial decision only, and it is likely the attorneys at this point who are speaking on behalf of the medical device and pharma giant.
Two, we had no longterm studies when this device was introduced looking at how the devices would perform over time in the human body.
Some of these devices, designed to induce a local inflammation, were discovered to migrate to new locations within patients. Reports of perforated organs (mostly the fallopian tube) were reported, along with some reports of the expulsion of the device into the pelvis.
Some of the devices appeared to undergo degradation over time, and this became alarming.
While the objective of the device was to create local inflammation, clearly some women were experiencing systemic issues. The theories of how this might be happening began to permeate the medical community. More patients began to hear of concerns regarding Essure, and more doctors started to listen.
The idea that a little device could elicit a systemic response was, at first, ignored. Patients presented with autoimmune disorders, systemic allergic reactions, and a myriad of symptoms, including:
- irregular bleeding
- generalized swelling
- joint pain
Physicians tried to remove the devices; however, coil removal proved difficult. There was no documented procedure for safe Essure removal. Pulling on the coils led to fragmentation of the devices and possible migration of the fibers. Cutting the devices also led to the unraveling of the coils.
For some women, these attempts have led to worsening symptoms and more widespread reaction to the components of the devices.
As a result of all of this, we have implemented a protocol for Essure Removal in our Portland gynecologic surgery practice.
Essure removal begins with:
- serum nickel testing
- imaging to identify:
- how many devices have been inserted
- the precise location of each device
- a lengthy discussion with our patients about surgical options
After device removal, our pathology department takes extensive notes and photographs. This will allow us to document the following:
- the condition of the Essure device
- where it was found in the body
- the condition of the surrounding tissue with specimens