The Dangerous Side of Essure Birth Control: What You Need to Know
What is Essure?
Essure is a permanent birth control method, often referred to as a form of female sterilization. It was designed as a non-surgical alternative to tubal ligation, the traditional procedure to “tie the tubes.” Essure consists of two small, flexible coils made from a combination of materials, including nickel-titanium alloy and polyester fibers. During the Essure procedure, a healthcare provider inserts these coils into the fallopian tubes through the vagina, cervix, and uterus. Over time, tissue grows around the coils, creating a barrier that prevents sperm from reaching and fertilizing an egg. One of the primary advantages initially touted for Essure was that it didn’t require incisions, general anesthesia, or a lengthy recovery period, as is common with surgical tubal ligation. However, over the years, there have been significant concerns and complaints about Essure. Many women reported serious complications, including chronic pain, device migration, perforation of the uterus or fallopian tubes, allergic reactions, and other issues.
The Dangers of Essure Permanent Birth Control
In recent years, the safety of Essure, a permanent birth control method, has come under scrutiny. Many women have reported severe complications associated with this device, leading some to undergo surgeries to have it removed. Just Call Moe Injury & Accident Attorneys are representing clients in Florida who’ve experienced severe health issues due to Essure.
Essure, once hailed as a groundbreaking non-surgical birth control solution, has become a significant concern due to the myriad of health complications reported by users. There have been reports of the Essure coils moving from their original position, which can lead to internal injuries. When the device migrates, it can perforate organs, cause internal scarring, or become embedded in the surrounding tissues. The device can puncture the uterus or fallopian tubes, leading to internal bleeding, infections, and other severe complications. One of the most common complaints is persistent and debilitating pain, often in the pelvic region. This pain can affect a woman’s daily activities and overall quality of life. Additionally, some women have experienced allergic reactions to the materials in Essure. These reactions can cause itching, rashes, and in severe cases, anaphylaxis.
Interventions and Long-Term Effects:
For many women, the solution to these complications has been to have the Essure device surgically removed. Depending on the severity and nature of the issues, procedures can range from a minimally invasive removal to a full hysterectomy. However, surgeries carry their own risks and potential complications. While surgical removal helps reduce the risk of further damage, the long-term side effects of Essure’s complications can be devastating. Chronic pain can persist even after the device’s removal. Scarring and tissue damage can impact fertility or cause long-term reproductive issues. Emotional and psychological effects, including depression and anxiety resulting from chronic pain or the ordeal of facing unexpected surgeries, can also linger.
For many women, the device has led to life-altering consequences. It’s essential for those currently using Essure to be fully informed of the potential risks and to seek medical consultation if they experience any adverse symptoms.
Symptoms and Complications from Essure:
- Chronic Pelvic Pain: Persistent pain in the pelvic region, sometimes severe enough to interfere with daily activities.
- Device Migration: The device can move from its intended location, potentially leading to other complications.
- Perforation: This involves the device puncturing or tearing the fallopian tubes, uterus, or other nearby organs.
- Allergic Reactions: Some women may react to the materials in the device, resulting in symptoms like itching, hives, rashes, or even more severe reactions like anaphylaxis.
- Ectopic Pregnancies: In some cases, pregnancies occur outside the uterus, most commonly in the fallopian tubes, which is potentially life-threatening.
- Device Breakage: Parts of the device breaking off, which can migrate or cause other complications.
- Infections: Including pelvic infections which may be severe and require treatment.
- Internal Scarring: Scar tissue formation around the device or where the device has migrated.
- Infertility: Difficulty conceiving or maintaining a pregnancy after deciding to have the device removed.
- Fever: Developing a fever, which could be indicative of an infection or an allergic reaction.
If anyone who has had the Essure device implanted experiences these or any other unusual symptoms, it is essential to seek medical attention promptly.
How is Essure Removed?
The removal of the Essure device can be complex due to its design and the way it interacts with the fallopian tubes. Over time, tissue grows around the inserted coils, securing them in place but also making removal more challenging.
- Hysteroscopic Removal: This method involves the use of a hysteroscope, a thin tube with a light and camera, which is inserted into the uterus through the cervix. Instruments can be passed through the hysteroscope to retrieve and remove the Essure devices from the fallopian tubes. This method is less invasive but might not be suitable for everyone, especially if the Essure devices have perforated the tubes or migrated.
- Salpingectomy: This surgical procedure involves removing the fallopian tubes entirely. Since the Essure coils are embedded in the tubes, removing the tubes ensures that the entire device is removed. This is a more common method of removal for women who’ve experienced complications with Essure.
- Cornual Resection: In this procedure, only a portion of the fallopian tube containing the Essure device is removed. It’s less radical than a complete salpingectomy but ensures the device is entirely removed.
- Hysterectomy: In more severe cases where there have been significant complications or if the Essure device has caused damage to the uterus, a complete hysterectomy might be recommended. This procedure involves the removal of the uterus, and in some cases, the cervix, fallopian tubes, and ovaries might also be removed.
- Laparoscopic Surgery: This is a minimally invasive surgical procedure using small incisions. Through these incisions, instruments and a camera are inserted to guide the surgeon in removing the Essure device. This method is preferred when feasible because it generally has a shorter recovery time and fewer complications than open surgery.
- Potential Complications: As with any surgical procedure, there are risks involved, including infection, bleeding, and damage to surrounding organs.
- Monitoring: It’s crucial to monitor for any signs of complications after the procedure. This includes infection symptoms, excessive bleeding, or any unexpected pain.
- Fertility Impact: If a woman wishes to conceive after Essure removal, it’s important to discuss fertility options and potential impacts with a healthcare provider.
Essure Removed from Market
Numerous lawsuits had been filed against Bayer, the manufacturer of Essure, by women who suffered various complications from the device.
Bayer’s Decision to Stop Selling Essure: In July 2018, Bayer announced that it would stop selling and distributing Essure in the United States by the end of that year. This decision followed increased scrutiny from the FDA and growing concerns about the safety of the product. However, Bayer maintained that their decision to discontinue Essure was based on declining sales and not because of concerns about the device’s safety.
FDA Actions: Before Bayer’s decision to halt sales, the FDA had taken several actions regarding Essure, including ordering Bayer to conduct a post-market surveillance study and to add a boxed warning – the most stringent warning available – to Essure’s product labeling. The FDA’s actions were in response to thousands of adverse event reports they received related to the device.
Lawsuits: Thousands of lawsuits were filed across the United States by women who claimed they suffered injuries and complications from the Essure device. These lawsuits generally claimed that Bayer failed to adequately warn about the risks associated with Essure and that the device was defectively designed.
Settlements: Bayer had begun settling some of these lawsuits. By 2020, Bayer announced that it had set aside around $1.6 billion to resolve the majority of the U.S. Essure claims. However, not all claims were settled, and it was expected that additional lawsuits would continue to be filed.
Multidistrict Litigation (MDL): Due to the large number of Essure cases, many of them were centralized into a federal multidistrict litigation (MDL) to streamline and manage the pretrial proceedings more efficiently. This does not mean the cases are treated as a class action; each plaintiff’s case remains individual, but certain procedural aspects are consolidated.
What are Essure Lawsuits?
Essure lawsuits are legal claims brought forward by women who experienced complications and injuries after having the Essure birth control device implanted. These lawsuits are against Bayer, the manufacturer of Essure. Plaintiffs allege that Bayer failed to provide adequate warnings about the risks associated with the device and that the device was defectively designed.
- Main Causes of Action in the Lawsuits:
Inadequate Warning: Many of the lawsuits claim that Bayer did not sufficiently warn both the public and the medical community about potential risks and complications associated with the Essure device.
- Defective Design: Plaintiffs argue that the Essure device was defectively designed, leading to a range of complications such as chronic pain, device migration, perforation of organs, allergic reactions, and more.
- Failure to Report: Some claims suggest that Bayer failed to report all known adverse events and complications to the FDA, thus preventing users from making a fully informed decision about using Essure.
- Complications Leading to Additional Surgeries: Many women reportedly had to undergo invasive surgeries, including full hysterectomies, to remove the device and address the complications it caused.
Complaints and Allegations in Essure Lawsuits
The Essure lawsuits have been marked by a myriad of complaints and serious allegations, which have put Bayer, the manufacturer of the Essure birth control device, under significant scrutiny. At the forefront of these complaints is the contention that Bayer failed to adequately warn users about the potential dangers and complications associated with the device. Women from various backgrounds and locales have come forward with harrowing stories of painful side effects, including device migration, organ perforation, and severe allergic reactions. Many plaintiffs believe that if they had been made fully aware of these risks, they would have opted for alternative methods of birth control.
In addition to the concerns about insufficient warning, another significant allegation against Bayer centers on the claim of defective design. Plaintiffs argue that the inherent design of the Essure device is flawed, leading to a cascade of adverse events. The coil-like structure, meant to induce scar tissue formation to block the fallopian tubes and prevent pregnancy, has in many reported cases moved from its intended position, causing injury. In some severe instances, the device’s migration has necessitated invasive surgeries, including hysterectomies, to rectify the complications and alleviate persistent pain.
Adding to the gravity of the situation, there have also been accusations that Bayer was less than transparent in its dealings with the FDA. Some lawsuits suggest that the pharmaceutical giant did not report all known adverse events and complications tied to the Essure device. This purported lack of transparency is seen by many as a betrayal of trust, as patients and medical professionals alike rely on accurate data and clear communication from manufacturers to make informed decisions about medical devices and treatments. The confluence of these complaints and allegations has played a pivotal role in shaping the trajectory of the Essure lawsuits.
Status of Essure Lawsuits
- FDA Scrutiny: Due to the influx of adverse event reports related to Essure, the U.S. Food and Drug Administration (FDA) took several actions. This included ordering Bayer to conduct post-market surveillance studies and adding a black box warning – the most stringent warning available – to the product labeling of Essure.
- Discontinuation of Sales: Amid growing concerns and declining sales, Bayer announced in 2018 that it would discontinue the sale and distribution of Essure in the U.S. by the end of that year. However, Bayer maintained that this decision was based on commercial reasons and not safety concerns.
- Settlements: As of 2021, Bayer had begun settling a significant number of these lawsuits. In 2020, Bayer announced it had set aside approximately $1.6 billion to resolve the vast majority of U.S. Essure claims.
- Multidistrict Litigation (MDL): Due to the large number of cases filed against Bayer over Essure, many were centralized into a federal multidistrict litigation (MDL). This procedure is used to streamline and manage pretrial proceedings efficiently for multiple cases of a similar nature. Each case within an MDL remains individual, but certain pretrial processes are consolidated.
Women who believe they have suffered complications from the Essure device are often encouraged to consult with legal professionals to understand their rights and potential entitlements.
Can I file an Essure lawsuit?
In August 2020, Bayer committed to a significant settlement of $1.6 billion, aiming to address the bulk of the existing Essure-related claims. This settlement was projected to cover approximately 90% of the then-existing 39,000 filed cases.
For those who haven’t yet sought legal recourse and weren’t included in that settlement, it might still be feasible to proceed. Nonetheless, it’s imperative to verify whether your potential claim still aligns with the prescribed statute of limitations.
How Long Do I Have to File an Essure Lawsuit?
The expiration period for the statute of limitations can differ based on the nature of your legal claim and your place of residence. For instance, numerous states have established a two-year limitation period for product liability cases, necessitating filing within two years from the injury’s occurrence. If the timeline surpasses the statute of limitations, your claim becomes void, restricting any further legal endeavors.
However, there are specific scenarios where exceptions might apply, particularly if the injury’s discovery was delayed due to concealed information. Some plaintiffs might contend that their delayed awareness of Essure’s harmful effects stemmed from Bayer’s omission of certain adverse event disclosures. To uphold such a stance, plaintiffs must substantiate that this alleged concealment hindered their recognition of the injury’s source.
Given the distinct variations in regulations, consulting a seasoned product liability attorney remains the optimal approach to discern whether you can still embark on an Essure lawsuit.
If you believe you have a valid claim regarding Essure complications, it’s essential to act promptly. Consult with us today to understand your rights, and determine the best course of action.
Who Can I Sue for Essure Complications?
If you’ve suffered complications from the Essure birth control device, the primary entity you would consider taking legal action against is the manufacturer. In the case of Essure, the responsible party is Bayer AG, a multinational pharmaceutical and life sciences company. While the bulk of the lawsuits have been against Bayer, in some cases, individuals might have grounds to sue medical professionals or entities if a doctor implanted the device improperly leading to complication or if a healthcare provider failed to adequately inform a patient about the potential risks associated with Essure or did not obtain informed consent.
It is important to note that most Essure lawsuits focus primarily on the manufacturer, Bayer, rather than individual medical professionals or facilities. This is because the primary allegations relate to the design, marketing, and disclosure practices of the company regarding the product.
If you or a loved one has suffered complications due to the Essure birth control device, you might be entitled to significant compensation. The attorneys at Just Call Moe Injury & Accident Attorneys understand the physical and emotional toll such complications can take. Let our dedicated team help you navigate the legal process and fight for your rights.
Frequently Asked Questions:
What is Essure?
Essure is a non-surgical, permanent birth control device that was marketed as a non-invasive alternative to tubal ligation. It consists of two small coils that are placed into the fallopian tubes to prevent pregnancy.
What are the reported complications associated with Essure?
Complications include chronic pain, device migration, perforation of the uterus or fallopian tubes, allergic reactions, and unintended pregnancies, among others.
Why would someone need to surgically remove Essure?
Due to the aforementioned complications, some women opt or are advised to undergo a surgical procedure, such as a hysterectomy, to remove the device and alleviate their symptoms.
Is there a time limit to file an Essure-related lawsuit?
Yes, many states, including Florida, have a statute of limitations for personal injury claims. It’s crucial to consult with an attorney promptly to ensure your rights are protected.
What if I had Essure removed but did not experience significant complications?
Even if you didn’t experience severe complications, you may still be eligible for compensation. The cost, risk, and pain and suffering from a subsequent surgery may mean that you are entitled to receive compensation. It’s essential to discuss your situation with an attorney to understand your rights.
How much does it cost to bring an Essure Claim?
It does not cost you anything to bring an Essure claim, unless we win. We operate on a contingency fee basis, which means that the client does not pay any upfront costs or hourly fees. Instead, the attorney’s compensation is contingent upon a successful outcome of the case. If the case is unsuccessful, and no compensation is obtained for the client, then you don’t owe us a dime. This arrangement allows individuals to pursue justice without the immediate financial burden, ensuring that the attorney’s interests align with those of the client, as both parties benefit from a successful resolution.