Why Are There Essure Lawsuits?
Bayer has faced lawsuits for failing to give proper warnings about the adverse effects of Essure Birth Control. Many women reported experiencing permanent damage to their bodies due to the implants.
Why Have Plaintiffs Filed Essure Lawsuits?
Thousands of Essure lawsuits have been filed against Bayer for injuries caused by the birth control device. The plaintiffs claimed that Bayer misled consumers and not enough research had been done to prove Essure’s safety before it was released.
Bayer has tried to blame physicians for Essure injuries by shifting blame with accusations of improper placement. In turn, lawsuits filed against Bayer have claimed that Bayer failed to provide adequate training, failed to monitor safety records adequately, and failed to notify the FDA of device malfunctions and adverse events as required.
Injuries described in lawsuits include:
- Severe abdominal, pelvic, or back pain
- Tears or holes (perforations) of the uterus or fallopian tubes
- Movement of the Essure inserts
- Ectopic pregnancy
- Uterine pregnancy
- Birth injuries
Which Companies Are Facing Essure Lawsuits?
The manufacturer of Essure, Bayer, has faced thousands of lawsuits. They were receiving lawsuits related to alleged product liability and/or medical malpractice.
Conceptus, original Essure manufacturer and developer of the device, has also faced lawsuits related to their negligence and refusal to share the adverse side effects with the public.
What Essure Lawsuit Settlements Have There Been?
Bayer has reportedly paid $1.6 billion to settle Essure Lawsuits. The approximate share was estimated at $45,600 per plaintiff, but those who have suffered more severe damage from Essure may have received more.
The Essure settlements were estimated to resolve about 90 percent of the nearly 39,000 claims filed. Bayer stopped selling Essure in 2018 but did not recall the device, which may have left many unaware they were at risk of adverse side effects.
What Essure Lawsuits Are There?
As of 2023, there are no known active Lawsuits pending against Bayer, as the company settled or resolved all of the United States Essure Lawsuits with $1.6 billion and additional court actions.
What Is Essure Birth Control?
Essure was a permanent type of birth control that was implanted in women who did not wish to become pregnant. It was considered a non-reversible, permanent form of birth control which was intended to avoid unwanted side effects that hormonal contraceptives may pose. It was said to have no effect on a woman’s menstrual cycle.
How Did Essure Birth Control Work?
Essure Birth Control was made up of small flexible coils constructed of fiber and metal. The device was placed in the fallopian tubes, which connect to the ovaries and the uterus. The coils were intended to create scar tissue within the fallopian tubes, to create a barrier that prevents sperm from reaching an egg.
Essure Birth Control was implanted through an intravaginal procedure, not requiring an incision and was an outpatient procedure, allowing the patient to leave the hospital or clinic on the same day of the procedure.
How Was Essure Implanted?
The doctor implanting the device used a speculum to view patient’s cervix, then using a cervical dilator to widen the cervix. The doctor then inserted a hysteroscope – a small tube with a camera – into the cervix and filled the uterus with saline to make it easier to view the fallopian tubes.
A second tube, the catheter that contained the Essure device, was inserted into one of the fallopian tubes. The device was left behind in the fallopian tube as the catheter was removed. The procedure was then repeated for the remaining fallopian tube.
Who Created Essure Birth Control?
Essure Birth Control was first created by Conceptus Inc. in 2002 in the United States. Conceptus was acquired by Bayer AG of Germany in June 2013.
Even though Conceptus is the original creator, Bayer assumed liability for Essure device injuries after acquiring Conceptus.
When Was Essure Approved by the FDA?
Essure was first approved in 2002 when Conceptus created the device. Since Essure’s approval, the FDA has been monitoring Essure and updating its safety warnings accordingly. The device was withdrawn from the market in 2018 but the agency continues to monitor reports on the device.
What Is Essure Birth Control Prescribed To Treat?
The Essure device was intended for women who did not wish to have children at all. It was considered a permanent birth control device to prevent women from ever conceiving children. It could also be considered a female sterilization device.
What Are the Side Effects of Essure Birth Control?
There are a wide array of side effects which may have been caused by Essure Birth Control, ranging from short-term, common side effects to long-term, adverse side effects.
What Are the Common Essure Side Effects?
Some of the short-term, common side effects may have included:
- Mild to moderate pain during and immediately after the Essure placement procedure
- Vaginal bleeding
- Nausea and vomiting
- Dizziness and lightheadedness
- Pelvic or back discomfort following the procedure
What Are the Severe Essure Side Effects?
Some of the more severe, or long-term side effects may have included:
- Abdominal, pelvic, or back pain
- Perforation of the uterus or fallopian tubes
- Unintended pregnancy
- Allergy or hypersensitivity reactions
- Essure devices unexpectedly moving to the abdominal or pelvic cavity
- Another surgical procedure if the patient or doctor decides to remove Essure
Women who had Essure may continue to be at risk of developing these injuries.
What Are the FDA’s Warnings About Essure Birth Control?
After receiving reports of Essure’s adverse effects, the FDA ordered Bayer to conduct more research about Essure’s benefits and risks. Study conclusions prompted the FDA to issue additional guidance for Essure in October 2016. Changes were made to Essure labeling to emphasize that it was a permanent, hysteroscopically-placed tubal implant device intended for female sterilization.
When Did the FDA Restrict Essure?
Through continuous research and evaluation, the FDA began restricting the sale and distribution of Essure Birth Control in April 2018. They also required Bayer to give doctors “Bayer’s Patient-Doctor Discussion Checklist,” which was to be signed by the patient before Essure implantation.
When Did Bayer Stop Selling Essure?
In April 2018, Bayer notified the FDA that they would no longer sell Essure after December 31, 2018. In August 2020, the FDA updated Essure informationto include additional adverse effects that Essure may cause. A “Problems Reported with Essure” web page has been continuously updated with the most recent information in March 2023.
Is Essure Birth Control Still on the Market?
Bayer voluntarily stopped the production and selling of Essure Birth Control on December 31, 2018. In September 2019, Bayer informed medical professionals that all units that have not already been implanted should be returned by the end of 2019.
Although Essure is not on the market, women may continue to experience adverse side effects from their implants. Removal of existing, implanted Essure devices has not been recommended by Bayer or the FDA and may continue to prevent pregnancy in women with the implants.