It’s time for the Essure medical device to be withdrawn from the market in the United States. The device has recently been removed from the European market, most of Latin America, Canada, and parts of northern Europe.
Here is the background. Essure is a non-incisional, permanent birth control system that uses small devices to block the fallopian tubes. In 1987, a doctor from Portland, Oregon, named Amy Thurmond presented data on a technique she had pioneered to treat infertility. Dr. Thurmond found that by unblocking fallopian tubes using a tiny catheter guided by an imaging technique called fluoroscopy she could re-open the fallopian and allow sperm to travel through it. After the presentation, Julian Nikolchev, a medical entrepreneur, approached her and opined that if she could open an otherwise closed fallopian tube that the opposite could also be true: you could use fluoroscopy to insert a device in the fallopian tube in order to block it.
In the early 1990s, Nikolchev founded a company called Conceptus to develop and market what it would call a “non-incisional permanent contraception” device after testing the idea in rabbits (whose fallopian tubes have a similar structure to those found in humans).
The prototype of Essure had a ribbonlike steel outer coil soldered to a tightly wound steel inner coil that was wrapped in polyethylene terephthalate (PET) fibers. The goal was not for the device itself to block the tubes but rather for it to stimulate a foreign body response. In other words, the fibers would irritate or inflame the tissue which would signal the immune system to surround the foreign body with cells that form scar tissue. This would encase the device and occlude the tubes, as researchers described in a 2001 study published in the journal Fertility and Sterility.
In 2013, Bayer purchased Conceptus for $1.1B dollars. Then on September 24, 2015, the FDA held an Advisory Committee meeting involving Essure. The goal of the meeting was as follows: “FDA is convening this committee to seek expert scientific and clinical opinion on the risks and benefits of the Essure System. The committee will be asked to evaluate currently available scientific data pertaining to the safety and effectiveness of the Essure System, such as events related to implant perforation/migration, device removal, chronic pain, allergic reactions, and unintended pregnancy. The committee will be asked to provide recommendations regarding appropriate device use, product labeling, and potential need for additional post-market clinical studies.”
On October 16, 2016, the FDA issued its final guidance on the Essure label and forced Bayer to accept a Black Box warning. A copy can be found here:
As of May 2017, there have been 16,373 adverse events related to Essure that were reported to the FDA. The reports include devices that broke apart, migrated out of the fallopian tubes or punctured other organs. There are also innumerable reports involving systemic autoimmune reactions, pregnancies (about 1,100), miscarriages and stillbirths. There are four reports of adult death.
If you have experienced complications as a result of the Essure device, please call Cowper Law LLP at 877.LAW.3707 to speak with an attorney about your rights. We are attorneys with experience in medical device and pharmaceutical litigation. Let us help fight for you.