This website covers the details of the Essure litigation, including the connection to severe abdominal injuries, recalls, settlements and providing you legal help.
Why Are Essure Lawsuits Being Filed
Hundreds of claims 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, women would have chosen a different form of birth control, such as a hysterectomy, salpingectomy, tubal ligation, tubal fulguration, or application of clips.
What is the Essure Birth Control
Essure is a permanent, 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 on November 4, 2002. The insertion of Essure does not require an incision (cut) or general anesthesia, and is also non-hormonal.
During the procedure, which generally takes ten minutes and can be performed in a physician's office, flexible coils 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 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. Essure is considered a permanent form of birth control and is not intended to be removed. For more information, visit Essure Wikipedia.
Essure Injuries & Side Effects
According to the Food and Drug Administration, the short-term risks from Essure include mild to moderate pain, cramping, vaginal bleeding, and pelvic or back discomfort.
|Unintended pregnancy, including ectopic pregnancy|
|Migration (movement) of Essure inserts through the fallopian tubes into the lower abdomen and pelvis|
|Perforation (puncturing) of the uterus or fallopian tubes|
|Rash and itching associated with possible nickel allergy|
If the Essure implant separates, breaks and/or moves, attempted removal often requires multiple surgeries, sometimes requiring removal of the uterus entirely.
The FDA received 5,093 reports of problems related to Essure for the period November 4, 2002, through May 31, 2015. The majority of reports received since 2013 have been voluntary reports, mostly from women who received Essure implants.
The most frequent problems have been pain (3,353), heavier menses/menstrual irregularities (1,408), headache (1,383), fatigue (966), weight fluctuations (936), movement of the device (482), device operating differently than expected (301), and device breakage (259).
Is there a risk of becoming pregnant after being implanted with Essure
According to the manufacturer’s data, this 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 indicated that up to 96 women out of 1,000 (a little less than 10%) would get pregnant within ten years, which is four times more than the risk of pregnancy associated with laparoscopic sterilization (about 2.5%).
Essure Lawsuit News
Law Protecting Bayer Against Liability Even Though its Essure Birth Control Has Injured Tens of Thousands: The Essure Permanent Birth Control implant was originally approved in November of 2002. Because it is actually implanted in the human body and is intended to protect, maintain, and enhance a patient’s health, the FDA considers it a Class III device. According to the FDA website, a device may also be classified as a Class 3 device when it is determined that the device “may present a potential unreasonable risk of illness or injury” or “for which there is insufficient information to make such a determination.” To read more, click Drug Safety News
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 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
Contraceptive implant alarm: Safety fear over popular NHS sterilisation device after women who use it are ten times more likely to need an operation later: Safety fears are raised today about a popular and convenient contraceptive implant provided on the NHS to 1,500 women every year. The Essure device offers permanent sterilization for those who no longer want to have children and takes only ten minutes to insert without needing surgery or general anesthetic. But research published today suggests there is a significant risk the implant can cause health problems. To read more, click The Daily Mail
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 Panel Hears Complaints, Gives Recommendations About Essure: The US Food and Drug Administration (FDA) held a postmarket panel meeting yesterday to evaluate the benefits and risks of the Essure System (Bayer Healthcare) for female sterilization after receiving complaints from thousands of women about the device. The Obstetrics and Gynecology Devices Panel of the FDA's Medical Devices Advisory Committee made a number of recommendations regarding patient selection, preimplantation medical counseling, product labeling, postimplantation testing and follow-up, and data collection. The panel did not vote on the recommendations, and the recommendations are not binding. To read more, click Medscape
Tens of Thousands of Women Injured by Defective Essure “Permanent” Birth Control: The Essure Permanent Birth Control implant was originally approved in November of 2002. Because it is actually implanted in the human body and is intended to protect, maintain, and enhance a patient’s health, the FDA considers it a Class III device. According to the FDA website, a device may also be classified as a Class 3 device when it is determined that the device “may present a potential unreasonable risk of illness or injury” or “for which there is insufficient information to make such a determination. To read more, click The Ring of Fire Network
Essure: Getting It Out Is Far More Complicated and Difficult Than Putting It In:The unfortunate fact is that while there is a great deal of information on the Essure device itself, there is little scientific or medical guidance when it comes to removal. The Essure is prone to breakage during the removal process, leaving tiny metal bits that migrate in the bloodstream, traveling to other organs and causing perforations. To read more, click Essure Removal Issues
Essure: FDA “Pre-Market Approval” Strikes Again: [The FDA] took the numbers that the manufacturer had presented to them in the pre-market approval process...they took them at face value, they didn't really look into them any further as far as the reports of pain that women were indicating in the initial studies when this product was first being looked at. There was plenty of information out there that should have tipped the FDA off that this product was going to be problematic. To read more, click Pre-Market Approval Fraud
Bayer Understates Number of Essure Complications – And Still Denies There is a Problem: The researchers claim that Bayer's own internal reports counted over 2,000 cases in which the device failed to prevent pregnancy – yet the FDA received reports on only 631 of them. . . [I]n February, the FDA reported a total of five fetal deaths in women who conceived despite having the Essure device. However, Madris Torres, founder and head of Device Events, closely examined the FDA public database, and found that number to be over 300. To read more, click Bayer Misleads Essure Problems
OB/GYNs Who Implant Essure Can Be Held Liable, Despite New FDA “Black Box” Warning: The name of Dr. Julio Novoa is not well known outside of the El Paso area – except by women who have been injured by the birth control device known as Essure, a product of Bayer's Conceptus division. Dr. Novoa is a leading advocate for these women, and he has a message for his colleagues and organizations: if you implant an Essure device into a patient and that patient is injured as a result, you bear liability. To read more, click Essure Medical Malpractice
Essure Lawsuit Videos
FDA and Scientific Studies Regarding Essure
FDA takes additional action to better understand safety of Essure, inform patients of potential risksOver 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 ControlThe 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 studyPatients 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 deviceThe 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
Essure Recall Information
As of this time, there has not been a recall of Essure. However, the FDA had a meeting with the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee on September 24, 2015, to hear scientific and clinical opinions as well as patients’ experiences with the Essure system.
In addition, the FDA has received more than 2,800 comments from the public on the Essure device. As a result of the committee meetings and public comments, the FDA ordered Bayer in February 2016 to begin conducting a post-market surveillance study regarding Essure’s benefits and risks.
The FDA also will require additional warnings to be added to the product labeling, including a Patient Decision Checklist to help make sure that potential users of Essure understand the benefits and risks of the device.
Have There Been Any Significant Essure Settlements
As of this time, there have been no large group settlements involving Essure. Litigation likes this takes many years to resolve, with teams of lawyers spending millions of dollars trying to determine exactly what occurred, and how it could have been prevented. Generally, large groups of settlements do not occur until such time as a few cases are tried before a jury, and the manufacturer is able to more thoroughly understand its financial risk.