Worldwide Bayer reports that almost 1 million of these devices have been fitted since it was first introduced in 2001. In the United States Essure was approved by the FDA in 2002 and originally manufactured by Conceptus Inc., which was purchased by Bayer for $1.1 billion in 2013. The device was developed to prevent pregnancy on a permanent basis and be used by women who had no desire to become pregnant but didn’t have the option of hysterectomy or other permanent procedure due to safety or inconvenience. Essure is implanted through the vagina in an outpatient procedure. The device consists of two coils, which are inserted into the fallopian tubes and over time cause scar tissue to form and prevent eggs from passing through the tubes.
Almost as soon as the device was introduced Conceptus began to receive reports of serious adverse events. These included rashes or eczema, chronic inflammation and chronic pain. These were attributed to being reactions from Essure being an implanted device but suspicions began building that the root of the adverse reactions might be metal hypersensitivity. Essure is a micro coil made of stainless steel, nickel titanium and polyethylene terephthalate (PET) fibers. Lawsuits have alleged that the stainless steel is prone to rusting inside patients, PET fibers degrade at 65 degrees and the nickel could be triggering allergic or autoimmune reactions.
Bayer, which purchased Conceptus in 2013, acknowledges that nickel is being released from the Essure device, but claims it is a small amount and downplays any connection to complications. With currently over 16,000 adverse reaction reports to the FDA, Bayer has been on the defensive ever since it acquired Essure. While Bayer continues to insist on the devices safety, in 2016 the FDA issued a black box warning for Essure. This is among the strongest actions the FDA can take – short of product recall – to warn the public about potential dangers of a drug or device.
The thousands of Essure related reports filed with the FDA list problems including pain, bleeding, device breakage and allergic reactions to nickel. Once the device has been inserted, removing it has also proved highly problematic according to doctors and patients. In many cases it requires emergency hysterectomies. In an outstanding report in the Washington Post (“The Battle over Essure”, July 26 2017) one women’s problems with Essure are chronicled that include an unintended pregnancy and a resulting hysterectomy after pieces of the device were found embedded in her uterus following the delivery. The report also gives a disturbing look at the economic factors that influence doctors to keep prescribing Essure and why Bayer, in spite of all mounting evidence to the contrary, keeps insisting the device is safe.
This isn’t enough for the thousands of women injured after being implanted with the Essure devices. High profile Fsacebook sites related to the issue have raised awareness and hastened the FDA to call hearings. There is a growing movement among victims claiming the black box warning isn’t enough and petitioning the FDA to remove Essure from the market. Bayer can no longer dodge their responsibility for producing this defective medical device or for failing to warn women of the risks associated with having it implanted.
At Saunders & Walker we have a long history of representing patients harmed by dangerous and defective drugs and medical devices. If you have used Essure for birth control and suffered any side effects or injuries after the device was implanted please do not hesitate to contact us for a free consultation.
Image Credit via Wikimedia Commons