Why Are There Essure Lawsuits?
Bayer has faced lawsuits for neglecting 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
- Hysterectomy
- Birth injuries
- Death
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, another Essure manufacturer, 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 in settling the Essure Lawsuits. The approximate share would be $45,600 per plaintiff, but those who have suffered more severe damage from Essure may receive more.
The Essure settlements will resolve 90 percent of the almost 39,000 claims filed. Bayer stopped selling Essure in 2018 but did not recall the device, leading many to experience the unknowingly adverse side effects.
What Essure Lawsuits Are There?
As of 2023, there are no active Lawsuits against Bayer, as the company has settled virtually all of the United States Essure Lawsuits with $1.6 billion.
What Is Essure Birth Control?
Essure is a permanent type of birth control that women could get implanted so they wouldn’t have to worry about taking any other contraceptives. It is a non-reversible form of birth control and aims to avoid all of the unwanted side effects that hormonal contraceptives tend to bring. It also does not affect the woman’s menstrual cycle.
How Does Essure Birth Control Work?
Essure Birth Control is made up of small flexible coils made with fiber and metal. This is placed in the fallopian tubes, which connect to the ovaries and the uterus. These coils create scar tissue within the fallopian tubes, which creates a barrier that prevents sperm from reaching an egg.
Essure Birth Control is implanted through a surgical procedure and is an outpatient procedure, which means that the patient can leave the hospital on the same day of the procedure.
How Is Essure Implanted?
The doctor implanting the device will use a speculum to look at the patient’s cervix and then use a cervical dilator to widen the cervix. After that, the doctor will insert a hysteroscope – a small tube with a camera – into the cervix and fill the uterus with saline to make it easier to spot the fallopian tubes.
The doctor will insert another tube, the catheter that contains the Essure device, into one of the fallopian tubes. The device will be placed in the fallopian tube as the catheter is removed. This is then repeated for the other fallopian tube.
Who Created Essure Birth Control?
Essure Birth Control was first created by Conceptus Inc. in 2002 in the United States. Conceptus was then acquired by Bayer AG of Germany in June 2013.
Even though Conceptus is the original creator, Bayer is wholly responsible for Essure after acquiring Conceptus.
When Was Essure Approved by the FDA?
Essure was first approved in 2002 when Conceptus created the device. Since its approval, the FDA has been monitoring Essure and updating its safety warnings accordingly.
What Is Essure Birth Control Prescribed To Treat?
This device is intended for women who do not wish to have children at all. It is a permanent birth control device and will prevent women from conceiving children. It could also be called a female sterilization device.
What Are the Side Effects of Essure Birth Control?
There are a wide array of side effects 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 are:
- Mild to moderate pain during and immediately after the Essure placement procedure
- Cramping
- Vaginal bleeding
- Nausea and vomiting
- Dizziness and lightheadedness
- Pelvic or back discomfort following the procedure
What Are the Adverse Essure Side Effects?
Some of the more adverse, long-term side effects include:
- 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
What Are the FDA’s Warnings About Essure Birth Control?
After receiving reports of Essure’s adverse effects, the FDA ordered Bayer to do more research about Essure’s benefits and risks. After the findings, the FDA issued the final guidance for Essure in October 2016 after public comments were made, changing the way Essure was labeled 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 decided to restrict 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 must be signed by the patient before Essure implantation.
When Did Bayer Stop Selling Essure?
In April 2018, the FDA was notified that Bayer would no longer sell Essure after December 31, 2018. After this, the FDA updated the Essure information in August 2020 to include all the adverse effects that Essure caused. The “Problems Reported with Essure” web page was continuously updated with recent information up to 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 their customers 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 still experience adverse side effects from their implants. As for women who are not experiencing these side effects, they can still use Essure to prevent pregnancy if they wish to do so.
Sources
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- Center for Devices and Radiological Health & Center for Devices and Radiological Health. (2018). Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization. U.S. Food And Drug Administration. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/labeling-permanent-hysteroscopically-placed-tubal-implants-intended-sterilization
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- Center for Devices and Radiological Health & Center for Devices and Radiological Health. (2022d). Essure Permanent Birth Control. U.S. Food And Drug Administration. https://www.fda.gov/medical-devices/implants-and-prosthetics/essure-permanent-birth-control
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- Office of the Commissioner & Office of the Commissioner. (2018). Statement from FDA Commissioner Scott Gottlieb, M.D., on manufacturer announcement to halt Essure sales in the U.S.; agency’s continued commitment to postmarket review of Essure and keeping women informed. U.S. Food And Drug Administration. https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-manufacturer-announcement-halt-essure-sales-us-agencys