Essure lawsuits are mass tort claims against Bayer for complications from their permanent birth control device, Essure. Essure has caused thousands of women to suffer from debilitating pain, perforated organs, and countless other serious medical complications, some of which can be fatal. In spite of the dangers, Bayer failed to warn doctors and patients about the risks of using Essure, and even hid evidence that it could hurt the people who took it.
The victims behind these lawsuits seek to hold Bayer legally accountable for its actions by pursuing compensation for:
- Medical expenses, including the costs of surgery to remove the device or correct the medical complications it has caused,
- Wages lost during recovery,
- Reduced earning capacity due to the injuries suffered, and
- Physical pain and suffering.
- 1. What is Essure?
- 2. Dangers of Essure devices
- 3. Medical complications associated with Essure devices
- 4. Evidence that Essure risks were covered up by Bayer
- 5. Lawsuits against Bayer for complications from Essure
- 6. Compensation available to victims of Essure
1. What is Essure?
Essure is a medical device that women can have implanted in their uterus as a form of permanent birth control.
The device itself looks like a long metal spring with a pin inside the coil. When inserted into each of the fallopian tubes, the Essure device is designed to create so much scar tissue that the tubes get blocked. This blockage prevents sperm from reaching the egg inside.
Essure was marketed as a revolutionary development in female birth control because no surgery or incision was necessary. Instead, the Essure device could be inserted by a catheter passed through the vagina and cervix and into the uterus in fewer than seven minutes.1 General anesthesia was not required, and the patient could go home soon after the procedure.
2. Dangers of Essure devices
Essure devices come with serious risks and side effects, even if the device works properly:
- Back pain,
- Joint pain,
- Pelvic pain, which can become chronic,
- Abdominal pain,
- Weight gain,
- Abnormally strong allergic reactions to known allergens,
- Allergic reactions to the metal in the Essure device,
- Metal toxicity,
- Vaginal bleeding,
- Changes in the menstrual patterns, and
Some of these symptoms persist even after the Essure device has been removed.
However, the Essure device has also been known to malfunction, break, or be poorly inserted, as well. This can lead to some severe problems:
- Expulsion of the Essure device through the vagina,
- Perforations or punctures in the uterine walls or uterus,
- Perforation or tear in the colon,
- Internal bleeding,
- Difficulties removing the device,
- Ectopic pregnancy, where the embryo forms outside the uterus,
- Miscarriage, and
- Internal migration of the Essure device or a piece of the device, which can lead to perforation of other organs.
Dangers like these are neither theoretical nor isolated. Between 2002 and 2017, the U.S. Food and Drug Administration (FDA) found 26,773 reports about adverse outcomes of Essure through the Manufacturer and User Facility Device Experience database, or MAUDE.2
Worse, these dangers can trigger medical complications that pose even more of a threat to the patient’s well-being.
3. Medical complications associated with Essure devices
Essure devices that malfunction can create medical complications can be dire and even fatal. These complications are especially severe if the Essure device moves out of the fallopian tube – a process known as migration – or if the Essure device fails to prevent a pregnancy.
3.1 Complications from Essure devices that migrate
Essure devices can migrate out of a patient’s fallopian tube if they break or are poorly inserted. If the device migrates, it can cause severe damage on its path from the uterus, and can create problems wherever it goes.
Women whose Essure device has migrated face:
- Extensive testing to find where the device went and what damage it has caused,
- An invasive and potentially complicated surgical procedure to remove the Essure device,
- Subsequent surgeries to repair perforations or tears in the fallopian tubes, uterine tract, or colon,
- Surgical procedures to repair damage along the device’s migratory route,
- Surgeries to repair perforations or tears in the organs or tissues where the device ended up lodging, and
- When the device broke before migrating, a surgical procedure to remove the remaining device from the fallopian tubes.
3.2 Complications from an unexpected pregnancy
Because Essure is a birth control device, many of the women who have had one implanted count on it to keep them from getting pregnant.
In many cases, women have chosen Essure because pregnancy is a serious health risk for them. When the Essure device fails to prevent a pregnancy, they are put into serious jeopardy.
The ineffectiveness of Essure has led to numerous medically necessary abortions, which have caused untold trauma and mental anguish on the women who have needed them. The device also drastically complicates the pregnancy, leading to a steep risk of miscarriage and fetal death.
4. Evidence that Essure risks were covered up by Bayer
Investigations and litigation has uncovered evidence that Bayer actively covered up the risks posed by Essure.
While it is owned by Bayer now, Essure was originally designed and manufactured by the company Conceptus. Conceptus rushed their Essure device through the FDA’s Premarket Approval process in 2002. The FDA let Essure enter the market before much research had been done on the long-term repercussions and dangers of the device, so long as Conceptus provided the FDA with safety data after five years. The FDA permitted this in spite of the fact that Essure was designed and touted as a permanent contraceptive device that would remain in a patient’s body over the long term.
In the 11 years after Essure was sold commercially and before Conceptus sold its rights to the device to Bayer, Conceptus habitually failed to submit safety data on time. When the safety reports were submitted, the data in them contained numerous problems, including:
- One in four women were not monitored for the full five-year period,
- Medical records were altered to reflect favorable data about Essure, and
- Information that surveyed patients would later describe as inaccurate.3
As news of the problems spread, more women learned that their painful experiences with Essure were not anomalies. In February 2016, the FDA required Bayer to further study the effects of Essure.4 In October 2016, the agency took the surprising step of adding a black box warning to Essure’s label, disclosing the risks of an Essure implant, rather than issue a recall. The warning would require patients to sign a three-page checklist to signify that they understood the risks before being able to receive the Essure implant.5
Bayer promptly announced that it would stop selling its Essure device in July, 2018, citing “business reasons.”6
5. Lawsuits against Bayer for complications from Essure
Tens of thousands of lawsuits have been filed against Bayer for the medical conditions and complications caused by Essure. These mass tort claims argue that Bayer knew of the dangers posed by Essure, but failed to warn doctors and patients of the risks. Without the ability to make an informed decision, innocent patients claim they were hurt by Bayer’s conduct and deserve to be compensated.
Despite the huge number of lawsuits that have been filed, there has not been a class action or multidistrict litigation (MDL) to consolidate the claims in federal court. A movement to create an MDL, which would have consolidated Essure claims in a single federal court for pretrial procedures like discovery and preliminary motions, was withdrawn.7
Instead, most of the lawsuits have gone through state court. Most of those have been filed in Pennsylvania or California. Dozens of the lawsuits in California, accounting for nearly a thousand victims, have been consolidated in Alameda County Superior Court, under Judge Winifred Y. Smith.8
More Essure lawsuits have been filed every week, especially since the birth control implant featured prominently in a Netflix documentary on dangerous medical devices, The Bleeding Edge, was released in July, 2018.
6. Compensation available to victims of Essure
Women who have suffered from the side effects and medical complications of Essure could be entitled to compensatory damages for what they have gone through. These damages are meant to compensate them for:
- Medical costs of removing the device and repairing damage that it caused,
- Anticipated future medical expenses associated with the Essure device,
- Wages lost and other professional setbacks encountered because of the device,
- Physical pain, and
- Mental suffering, trauma, and anguish.
Additionally, punitive damages might be available, as well. Victims can pursue punitive damages to punish companies for misleading them or actively concealing the dangers of their products. In some cases, the amount of punitive damages awarded to a victim can be far more than the compensatory damages they recover.
Pursuing compensation, though, requires filing a lawsuit or joining one of the existing cases currently winding through court. Call the mass tort attorneys at the Shouse Law Office for help.
- See Mino M, Arjona JE, Cordon J, Pelegrin B, Povedano B, Chacon E, “Success Rate and Patient Satisfaction With the Essure Sterilisation in an Outpatient Setting: A Prospective Study of 857 Women,” BJOG (May 16, 2007).
- FDA Activities: Essure.
- See Citizen Petition to U.S. Department of Health and Human Services (February 20, 2015).
- FDA Press Release, “FDA Takes Additional Action to Better Understand Safety of Essure, Inform Patients of Potential Risks,” (February 29, 2016).
- See Roni Caryn Rabin, “Bayer’s Essure Contraceptive Implant, Now With a Warning,” The New York Times (November 21, 2016).
- Press Release, “Bayer to Voluntarily Discontinue U.S. Sales of Essure at End of 2018 for Business Reasons,” (July 20, 2018).
- See In re: Essure Birth Control Device Products Liability Litigation, MDL No. 2739 (order deeming motion withdrawn and vacating the September 29, 2016, hearing order) (August 12, 2016).
- Essure Product Cases and Coordinated Actions, Judicial Council Coordination Proceeding No. 4887 (December 21, 2016).