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Table Of Contents
- 5th Death Linked to Essure
- Latest Development
- FDA Updates Adverse Event Reporting with Essure
- Essure Lawsuit Overview
- Essure Side Effects
- Essure Lawsuits: Comprehensive Timeline and Key Studies
- Key Studies and Findings on Essure Birth Control Device
- Understanding the Process of an Essure Birth Control Lawsuit
- FAQs:
- Get a Free Essure Lawsuit Evaluation With Our Lawyers
5th Death Linked to Essure
At least 3 late-term miscarriages and 2 patient deaths have been linked to the Essure contraceptive, according to ABC News. The latest fatality occurred in a woman who died while her doctor was implanting the device.
According to the report, the woman ‘coded’ when the doctor tried to insert the 2nd coil into her Fallopian tube. Additionally, it says that “prior to the coding the patient was noted to be shaking a lot and experienced generalized seizure activity.”
An autopsy revealed that the woman’s uterus had been punctured – though the pathologist was unable to say for certain whether Essure caused her death.
Latest Development
The Essure case continues to see significant updates, from regulatory actions to legislative measures and international recalls. Here are the most recent developments:
FDA Orders ‘Black Box Warning’ on Essure Labeling
February 29, 2016 [1] – As claimed by the U.S. Food & Drug Administration (FDA), the agency announced today that it will require German drugmaker Bayer AG to include a new ‘black box warning’ on Essure labels “designed to call attention to serious or life-threatening risks.” FDA also called upon Bayer to perform surveillance in order to assess “risks of the device in a real-world environment,” and said the agency will use the results to “determine what, if any, further actions related to Essure are needed to protect public health.”
The company is required to follow over 2,000 Essure recipients for a minimum of 3 years.
Congressman Introduces ‘E-Free Act’ to Ban Essure
November 4 – According to NBC News, Representative Mike Fitzpatrick (D-PA) introduced today a bipartisan bill called the ‘E-Free Act’ which would require the FDA to remove Essure from the U.S. market [2].
“The FDA has received over 5,000 formal complaints related to the device and over 22,000 women have joined together on Facebook to share their stories of how the Essure device ruined their lives,” Fitzpatrick said. “Essure has caused at least five fetal deaths in women who became pregnant after Essure was placed. At least four women have been killed by Essure.”
Essure Recalled in Brazil
February 22, 2017 – According to Modern Health Care, Brazil’s National Health Surveillance Agency (ANVISA) has recalled Essure from the Brazilian market [3].
Anvisa is suspending the importation, distribution, marketing use, and dissemination of Essure. It is also recalling units that had already been distributed.
Current Settlement Amounts for Essure Lawsuit
- Average Settlement: $45,600 per claimant, contingent on the severity of injuries.
- Total Settlement Fund: Bayer agreed to pay $1.6 billion to resolve approximately 90% of the nearly 39,000 U.S. claims related to the Essure device.
- High Severity Claims: Individuals with severe injuries may receive significantly higher compensation than the average.
FDA Updates Adverse Event Reporting with Essure
The Food and Drug Administration has issued a letter (PDF) to Bayer outlining conditions for submitting additional post-market information about the Essure system. The letter applies to reportable injuries from social media with ongoing litigation regarding the Essure system.
FDA granted Bayer’s request for a variance from some reporting requirements but imposed other conditions for reporting to ensure public health.
Per the conditions, Bayer must start providing device reports to the Food and Drug Administration in July 2020 and continue submitting additional events every month. The agency will make these events publicly available on its Problems Reported with Essure web page.
Essure Lawsuit Overview
Conceptus Inc., a subsidiary of manufacturer Bayer AG, developed the Essure procedure. The contraceptive device is inserted into each of the recipient’s Fallopian tubes by a certified doctor. The inserts work to form a natural barrier that keeps sperm from reaching the egg, thereby preventing pregnancy.
The Food and Drug Administration approved Essure on November 4, 2002. According to Bayer, Essure kits are sold in at least 23 countries, and about 750,000 of the contraceptives are currently in use worldwide.
What’s the Problem?
On May 3, 2015, an article published in the New York Times reported that the Food and Drug Administration had received over 4,000 adverse event reports associated with the Essure contraceptive.
These serious injuries included severe pain, perforated organs, tubal sterilization, heavy menstrual periods, and coils that pierced recipients’ Fallopian tubes and became lodged in other internal organs.
According to the NCBI, in a pre-approval clinical trial that involved 269 women ages 23 to 45, Essure was successfully inserted into 200 patients [4].
However, in 9 women the contraceptive perforated the Fallopian tube, was expelled, or became stuck elsewhere in the body. Additionally, nearly 1 in 10 women complained of painful intercourse / abdominal pain, and 1 in 8 reported painful menstrual periods during the first 3 months.
During a later trial of 518 women, only 449 were able to rely on Essure. In 21 patients, the contraceptive pierced their Fallopian tubes and was expelled or migrated to other parts of the body.
At least 8 women required a hysterectomy or surgery to remove a misplaced stainless steel inner coil. As in the first trial, participants complained of back pain, abdominal pain, and pain during intercourse.
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Essure Side Effects
Our lawyers are reviewing potential Essure lawsuits for women who suffered one or more of the following complications after being implanted with the Essure system:
| Category | Symptom/Complication | Additional Notes |
|---|---|---|
| Emergency Symptoms | Death | Statistics: 115 reported deaths |
| Ectopic Pregnancy | High risk due to device failure | |
| Organ Perforation | Can lead to life-threatening conditions | |
| Severe Symptoms | Hysterectomy | Statistics: 5% of patients required hysterectomy |
| Device Migration | Movement of components outside Fallopian tubes | |
| Common Symptoms | Pain | Statistics: 40,490 reports of pain |
| Bleeding | Frequently reported side effect | |
| Allergic Reactions | Potentially severe; linked to device material | |
| Chronic Inflammation | May require medical intervention | |
| Infections | Increases risk of further complications | |
| Device Issues | Device Breakage | Leads to additional surgical procedures |
| Fracturing of the Device | Common during or after placement | |
| Pregnancy-Related | Unplanned Pregnancies | Device failure to prevent conception |
| Miscarriage | Increased risk due to device failure | |
| Unwanted Pregnancy | Often results in emotional and physical stress | |
| Other Symptoms | Scar Tissue Formation | Can lead to chronic pain and surgical interventions |
| Hair Loss | Rare but reported by multiple recipients | |
| Weight Fluctuations | Hormonal or device-related side effects |
Essure Lawsuits: Comprehensive Timeline and Key Studies
This section provides a detailed overview of the key events, studies, and legal developments surrounding the Essure birth control device.
April 2019: Philadelphia Supreme Court Allows Cases to Proceed
- The Philadelphia Supreme Court ruled that six women should be allowed to pursue personal injury claims and three plaintiffs should proceed with breach-of-warranty suits against Bayer AG and Conceptus Inc.
- Bayer’s request for summary judgment citing statutes of limitations was denied, enabling these cases to proceed.
December 2018: FDA Requires New Study Protocol
- The FDA required Bayer to revise its post-marketing study, extending the observation period from three years to five years.
- This revision aimed to provide more comprehensive long-term safety data following Essure’s market withdrawal.
April 2018: FDA Restricts Essure Sales
- New FDA requirements limited Essure’s distribution to patients who signed a document acknowledging the risks associated with the device after consulting their doctor.
December 2016: Missouri Lawsuit Proceeds
- A federal judge in Missouri denied Bayer’s motion to dismiss lawsuits filed by 32 women claiming injuries caused by Essure. The cases were remanded to state court for further proceedings.
July 2016: MDL Proposed
- Plaintiffs filed a motion to consolidate over 1,000 Essure lawsuits into a multidistrict litigation (MDL) under U.S. District Judge Gerald McHugh in Pennsylvania. The motion sought to streamline cases alleging side effects from Essure.
June 2016: Study Reveals FDA Used Flawed Data
- A study published in Obstetrics and Gynecology criticized the FDA for relying on short-term evidence and insufficient post-market follow-up to approve Essure.
February 2016: Black Box Warning Issued
- The FDA mandated the addition of a Black Box Warning to highlight severe risks, including device migration, perforation, and persistent pain.
September 2015: FDA Panel Evaluates Safety
-
The FDA’s Obstetrics and Gynecology Devices Panel reviewed Essure’s safety due to numerous adverse event reports in the MAUDE database. Issues included incomplete procedures, device migration, tubal perforations, severe pain, bleeding requiring hysterectomy, device-related deaths, and hundreds of unintended pregnancies [5].
Key Studies and Findings on Essure Birth Control Device
The following studies and findings highlight critical issues surrounding the Essure birth control device, including concerns over safety, regulatory shortcomings, and long-term risks for patients.
Essure Study Receives New FDA Protocol
In December 2018, the FDA required Bayer to revise its post-marketing study of Essure, mandating a longer follow-up period to ensure accurate long-term safety data.
Purpose of Revision:
- Collect data on adverse risks that may lead to device removal.
- Ensure comprehensive tracking of long-term health outcomes.
The trial will now follow women who were implanted with Essure for 5 years instead of the initially requested 3, giving the FDA “longer-term information on adverse risks of the device, including issues that may lead women to have the device removed.”
Conceptus Cited for Failing to Conduct Follow-Up Studies
The FDA raised concerns about inadequate monitoring during Essure’s clinical trials, which only followed participants for one or two years despite the device being intended for lifelong use. The following are key findings from the trials:
First Trial (269 Participants):
- 171 completed the five-year follow-up.
- 5 women required hysterectomies, and 1 became pregnant.
- 270 adverse events were reported, though only 17 were attributed to Essure.
Larger Trial (518 Participants):
- 366 participants were followed for five years.
Some of the reported issues included:
- 38% experienced recurrent heavy menstrual periods.
- 1 in 20 reported recurring pelvic pain.
- 1 in 15 experienced recurrent painful periods.
- 1 in 25 had recurring pain with intercourse.
These findings were published in the Journal of Minimally Invasive Gynecology on April 24, 2015 [6].
FDA Used Flawed Data to Approve Essure
A 2016 study published in Obstetrics and Gynecology revealed significant flaws in the FDA’s approval process for Essure. The device was approved based on short-term evidence and insufficient post-market surveillance [7].
Classification: Essure was identified as one of 18 high-risk medical devices approved between 2000 and 2015 that posed serious patient risks.
Essure Patients 10x More Likely to Require Additional Surgeries
A landmark study by Weill Cornell Medicine highlighted the elevated risks associated with Essure compared to traditional sterilization methods [8].
Published in the British Medical Journal (BMJ), it found that Essure patients were 10 times more likely to require additional surgeries [9].
Study Details:
- Analyzed records of 8,048 Essure patients and 44,278 tubal ligation patients (2005-2013).
- Measured reoperation rates within one year of the procedure.
Notable Statistics:
- Essure patients faced a significantly higher likelihood of undergoing complex reoperations.
- “One in 49 or 50 women required another surgery, which was often more complicated,” according to Dr. Art Sedrakyan, lead author of the study.
These findings reveal serious safety concerns and highlight the need for comprehensive post-market surveillance and informed decision-making for patients considering medical devices like Essure.
“Essure helped them avoid surgery in some instances, but they are still facing a 10-fold high risk of getting that surgery done,” Dr. Art Sedrakyan, lead author of the study, told NBC News [10]. “That translates to one in 49 or 50 women getting this surgery again. And that surgery is likely to be much more complicated than the laproscopic approach that they should be considering.”
Understanding the Process of an Essure Birth Control Lawsuit
Navigating an Essure birth control lawsuit can be a lengthy process, influenced by various factors such as the complexity of your case and the severity of injuries. The following is a breakdown of the steps to help you better understand what to expect.
Filing the Lawsuit: The First Step
The process begins with filing pleadings:
- Plaintiff’s Complaint: A document outlining the allegations and claims against the defendant.
- Defendant’s Answer: Bayer or the opposing party responds to the complaint, often disputing the claims.
Discovery Phase: Fact-Finding Process
After pleadings are filed, the case enters the discovery phase, during which both parties exchange information. This phase includes:
- Evidence Sharing: Both sides share relevant documents and records.
- Interrogatories: A formal list of questions exchanged between the parties to gather additional details.
Pre-Trial Conference and Settlement Discussions
Before proceeding to trial, a pre-trial conference is usually held:
- Settlement Discussions: Both parties meet to explore the possibility of resolving the case without going to court.
- Outcome: If no settlement is reached, the case moves to trial.
Litigation Phase: Presenting the Case
If the case proceeds to trial, the litigation phase involves:
- Trial Duration: Trials can last several days to weeks, depending on the complexity of the evidence and arguments.
- Presentation of Evidence: Both the plaintiff and Bayer present their claims and defenses to the court.
Bayer’s Likely Defense: Preemption Provision
During litigation, Bayer often relies on the preemption provision as a defense:
- Preemption Argument: Bayer may argue that FDA approval of Essure protects the company from liability claims.
- Impact on Plaintiffs: This defense can complicate the legal process and require strong evidence from the plaintiff’s side.
Documentation Guide for Essure Lawsuits
If you are pursuing an Essure lawsuit, keeping thorough records is essential. Here’s a straightforward guide to help you document everything you need for your case.
1. Collect Medical Records
- Medical History: Gather all records of your health before the Essure implant.
- Treatment Records: Include reports of doctor visits, tests, and treatments related to Essure complications.
- Reports of Issues: Save copies of any adverse event reports you filed with your doctor or the FDA.
2. Note Key Dates
- Implant Date: The date your Essure device was implanted.
- First Symptoms: When you first experienced problems.
- Medical Visits: Track all appointments with healthcare providers about Essure issues.
- Surgeries: Record any procedures, such as a hysterectomy, caused by Essure complications.
3. Keep a Symptom Log
Track your symptoms with this simple format:
- Date and Time: When the symptoms started and how long they lasted.
- Type of Symptoms: Pain, bleeding, allergic reactions, etc.
- Severity: Rate symptoms on a scale of 1 to 10.
- Daily Impact: Note how symptoms affected your work or daily life.
4. Save Healthcare Communication
- Emails and Letters: Keep copies of all written communication with your doctors.
- Appointment Notes: Write down what was discussed during medical visits.
- Follow-Ups: Record any questions or concerns you raised about Essure complications.
Organizing your records and tracking symptoms can build a stronger case for your Essure lawsuit. Detailed documentation makes it easier to prove your claims and seek fair compensation.
How Long Will My Essure Birth Control Lawsuit Take?
The duration of an Essure birth control lawsuit can vary significantly based on several factors, including the complexity of the case and the severity of the injuries. Whether the case settles out of court or proceeds to trial also significantly determines the timeline.
Related Article: IUD Perforation Symptoms & Treatment Info
See all related medical device lawsuits our lawyers have taken on.
FAQs:
What Is Essure?
Essure is a permanent birth control device consisting of metal coils that are inserted into the fallopian tubes to prevent pregnancy. It works by causing scar tissue to form, blocking the tubes, and preventing sperm from reaching the egg.
People are filing lawsuits related to Essure due to reports of severe side effects and complications experienced by users. These may include chronic pain, allergic reactions, migration of the device, and other severe health issues.
What Are Common Side Effects Associated With Essure?
The common side effects that are associated with Essure include abdominal pain, heavy or irregular bleeding, device migration, perforation of the uterus or fallopian tubes, and allergic reactions to the materials used in the device.
What Is the Average Payout for an Essure Lawsuit?
The average payout for an Essure lawsuit is approximately $45,600, though amounts can vary based on the injuries’ severity. Individuals with more severe injuries may receive significantly higher compensation.
Get a Free Essure Lawsuit Evaluation With Our Lawyers
The Medical Device Litigation Group at Schmidt & Clark, LLP law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Essure Lawsuits. We are handling individual litigation nationwide and currently accepting new permanent birth control side effects cases in all 50 states.
Again, if you or a loved one was injured by the side effects of Essure birth control, you should contact our law firm immediately. You may be entitled to compensation by filing a class-action suit and our lawyers can help.
References:
- https://www.schmidtandclark.com/wp-content/uploads/ESSURE-GUIDANCE-2-29-cln.pdf
- https://www.nbcnewyork.com/news/local/essure-congressional-bill-pull-birth-control-device-off-market/2013698/
- https://www.modernhealthcare.com/article/20170221/NEWS/170229985/brazil-suspends-and-recalls-essure
- https://www.ncbi.nlm.nih.gov/pubmed/12773450
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm
- http://www.ncbi.nlm.nih.gov/pubmed/25917278
- http://www.ncbi.nlm.nih.gov/pubmed/27159747
- http://www.wsj.com/articles/study-raises-new-concerns-about-bayer-sterility-device-1444775581
- http://www.bmj.com/content/351/bmj.h5162
- https://www.nbcnews.com/health/womens-health/essure-sterilization-device-causes-serious-safety-concern-study-n443966
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