The Essure lawsuits claim the birth control device has been defectively designed so that it can fracture and move within a woman’s body. This failure can cause a woman's uterus and fallopian tubes to become punctured.
What Do We Know About the Essure Lawsuits
More than 16,000 lawsuits have been filed against Bayer and Conceptus Inc. (the manufacturers of Essure) by women who have suffered severe abdominal damage when the birth control device moves and punctures the uterus and fallopian tubes.
Attorneys state that if doctors and patients had known the risks, then women would have chosen a different form of birth control, such as a hysterectomy, salpingectomy, tubal ligation, tubal fulguration, or application of clips.
The Key Legal Issue
The Essure birth control device was negligently designed so that it can break apart and cause harm to a woman's uterus and fallopian tubes.
Essure Injuries & Side Effects
According to the Food and Drug Administration (FDA), the short-term risks from Essure include mild to moderate pain, cramping, vaginal bleeding, and pelvic or back discomfort.
|Unintended pregnancy, including ectopic pregnancy (pregnancy occurring outside of the uterus)|
|Migration (movement) of Essure through the fallopian tubes into the lower abdomen and pelvis|
|Perforation (puncturing) of the uterus or fallopian tubes|
|Allergic reaction to the Essure device, especially in women who have a sensitivity to polyester fibers, nickel, titanium, stainless steel, platinum, and silver-tin.|
|Joint pain, fatigue, and other autoimmune disease symptoms.|
If the Essure implant separates, breaks and/or moves, attempted removal often requires multiple surgeries, sometimes requiring removal of the uterus entirely (a hysterectomy).
The FDA has received more than 26,000 reports of problems related to Essure for the period 2002 through the present. The majority of the reports received since 2013 have been voluntary reports, mostly from women who received Essure implants.
The most frequent problems have been pain, heavier menses/menstrual irregularities, headache, fatigue, weight fluctuations, movement of the device, device operating differently than expected, and device breakage.
The FDA has associated the use of Essure with at least eighteen miscarriages. However, a private consulting firm places the number closer to 300.
Essure Warnings & Recalls
In September 2015, the FDA held a meeting with the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee to hear scientific and clinical opinions as well as patient experiences with the Essure system. As a result of the committee meetings and public comments, the FDA ordered Bayer to begin conducting a post-market surveillance study regarding Essure’s benefits and risks.
In November 2016, the FDA required Bayer to place a black box warning on Essure packages warning of the risks of perforation, abdominal pain, and allergy, among other potential complications.
In April 2018, the FDA restricted sales of Essure to medical providers who agreed to go through a checklist of potential issues with patients before agreeing to implant Essure.
In July 2018, Bayer revealed that it would not sale Essure in the United States by the end of 2018.
What is the Purpose of Essure
Essure is a permanent, irreversible, non-surgical birth control device for women developed by Conceptus Inc., a company owned by Bayer. Essure was approved for use in the United States in 2002 as part of the FDA pre-market approval process. The insertion of Essure does not require an incision (cut) or general anesthesia, and is also non-hormonal. More than 750,000 devices have been implanted in women worldwide.
During the procedure, which generally takes ten minutes and can be performed in a physician's office, flexible metal coils (including nickel and titanium) are inserted through the vagina and cervix and into the fallopian tubes. Once in place, tissue grows in and around the device over a period of three months and forms a blockage in the fallopian tubes. The build-up of tissue creates a barrier that keeps sperm from reaching the eggs, thus preventing conception.
Three months after the device is placed in the body, a radiologist performs testing to make sure that the fallopian tubes are completely blocked and that the patient can rely on the Essure birth control system to prevent pregnancy. A contrast agent (dye) is injected through the cervix, and an x-ray is taken of the Essure coils to make sure no dye leaks past the medical device. This test is referred to as The Essure Confirmation Test.
Essure received pre-market approval by the FDA in 2002. This approval was based on Conceptus conducting two future studies, which Conceptus failed to do. Additionally, Conceptus received more than 30,000 reports of problems with Essure over its first ten year period. Yet, Conceptus failed to issue a warning to the public about these problems, and failed to notify the FDA of them.
According to the manufacturer, the Essure medical device is 99.83% effective at preventing pregnancy. However, a study published in the journal Contraception that examined the effectiveness of Essure in real-world conditions provided convincing evidence that this percentage is highly inflated.
Non-perfect placement of the device, as well as an incomplete blockage of the fallopian tubes, are some of the conditions that may increase the risk of an unexpected pregnancy. Also, Conceptus’ researchers did not examine women younger than 21 nor older than 45, neither did they follow up with patients after a five-year period.
Real-world data has incidated that up to 96 women out of 1,000 (9.6%) will get pregnant within ten years. Thus, the actual effectiveness of the Essure device is likely between 91% to 99%.
Essure Lawsuit News
Bayer to Pay $1.6 Billion to End U.S. Suits Over Contraceptive:
Bayer AG agreed to pay $1.6 billion to resolve most of the U.S. litigation over its now-withdrawn Essure contraceptive device, which some women said caused excessive bleeding and pelvic pain or failed to prevent pregnancies. To read more, click Bloomberg News - Essure Settlement
Bayer Essure Lawsuits Skyrocketed as FDA Pushed Stronger Warnings:
The number of Essure suits has skyrocketed over the last two years after U.S. regulators forced Bayer officials to beef up warnings about the device’s risks -- including bleeding, pain and organ damage -- and put sales restrictions on the product. To read more, click Bloomberg News - Essure Lawsuits Skyrocket
Bayer to Stop Selling Controversial Birth Control Device That Sparked Thousands of Lawsuits:
Essure, a non-surgical sterilization device that is inserted into the fallopian tubes and prevents pregnancy by producing scar tissue that blocks sperm from fertilizing eggs, will no longer be available in the U.S. after December 31, 2018. To read more, click Time Magazine
FDA mandates new warnings, new data for Essure contraceptive device:
The U.S. Food and Drug Administration said it will require a new "black box warning" label for Essure, an implantable permanent contraceptive device. A black box warning in the labeling of products is "designed to call attention to serious or life-threatening risks," according to the FDA website. Monday's announcement comes after more than 5,000 women filed grievances with the FDA between November 2002 and May 2015, complaining of unintended pregnancies, miscarriages, stillbirths and severe pain and bleeding after an Essure implantation. To read more, click CNN News - FDA Warning
FDA sets February target for action on much-debated contraceptive implant:
Federal health officials aim to release their findings on a much-debated contraceptive implant by the end of February. The Food and Drug Administration posted a brief statement online about its review of the metallic device, Essure, which has been subject to thousands of complaints by women reporting chronic pain, bleeding and headaches. To read more, click U.S. News and World Report
Essure Sterilization Device Causes 'Serious Safety Concern': Study:
A new study appears to confirm what some women have said about a permanent birth control device called Essure. Researchers found that women who used the device had 10 times as many operations to fix problems as women who had surgery instead. The Food and Drug Administration is taking a look at the complaints about the device — a pair of metal coils inserted into the fallopian tubes. Thousands of women say they've had problems after being fitted with it, from allergies to the metal used to severe abdominal pain. To read more, click NBC News
Experts question safety of birth control implant linked to pain:
A 13-year-old birth control implant came under new scrutiny Thursday as federal health experts discussed a host of problems reported by women implanted with the metallic device, including chronic pain, bleeding and fatigue. The Essure implant from German manufacturer Bayer is frequently pitched to women as the only non-surgical option for permanent birth control. But since 2013, the Food and Drug Administration has received thousands of complaints about the device from women and doctors. The agency convened a meeting Thursday to have its outside experts review Essure's safety and effectiveness. The panel's recommendations are not binding. To read more, click CBS News
FDA and Scientific Studies Regarding the Essure Birth Control Device
FDA restricts sale and distribution of Essure to protect women and to require that patients receive risk information
"We’ve been closely evaluating new information on the use of Essure, and based on our review of a growing body of evidence, we believe this product requires additional, meaningful safeguards to ensure women are able to make informed decisions about risk when considering this option,” said FDA Commissioner Scott Gottlieb, M.D. To read more, click FDA Essure News Release
FDA takes additional action to better understand safety of Essure, inform patients of potential risks
Over the past 14 years, FDA has reviewed a significant amount of information related to the use of Essure. While the FDA believes Essure remains an appropriate option for the majority of women seeking a permanent form of birth control, some women may be at risk for serious complications. These may include persistent pain, perforation of the uterus or fallopian tubes from device migration, abnormal bleeding and allergy or hypersensitivity reactions. To read more, click FDA Safety Announcement
Essure Permanent Birth Control
The FDA convened a meeting of the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee on September 24, 2015, to hear expert scientific and clinical opinions as well as patients’ experiences regarding the benefits and risks of the Essure System. In addition, a public docket soliciting comments on the device remained open from July 22, 2015 until October 24, 2015. FDA received more than 2,800 comments in this docket and is reviewing each comment and the views and perspectives expressed. To read more, click FDA Products and Medical Devices
Safety and efficacy of hysteroscopic sterilization compared with laparoscopic sterilization: an observational cohort study
Patients undergoing hysteroscopic sterilization have a similar risk of unintended pregnancy but a more than 10-fold higher risk of undergoing reoperation compared with patients undergoing laparoscopic sterilization. Benefits and risks of both procedures should be discussed with patients for informed decisions making. To read more, click British Medical Journal
Radiological assessment of placement of the hysteroscopically inserted Essure permanent birth control device
The most common complications are perforation, migration (toward the uterine or peritoneal cavity), and occlusion failure. In hysterosalpingography, vascular intravasation is the most common cause of diagnostic error. Radiologists need to know how to recognize the device on different imaging techniques, how to check that it is correctly placed and functioning, and how to diagnose complications. To read more, click Radiologia