Why Would You Need Essure Birth Control Side Effects Lawyers?
Essure is a form of permanent birth control that has been linked to devastating injuries to women implanted with the device. Some of these injuries are severe enough to lead to multiple surgeries or even death. This is directly contrary to the information the device’s manufacturer, Bayer, has disseminated about the device. Women believed they were receiving a simple, safe device that would prevent them from becoming pregnant. Thinking that a non-hormonal, non-surgical option sounded perfect for them, they had Essure implanted, but soon after, they discovered that the device was defective, and their lives have been completely changed because of it.
Why Choose Parker Waichman LLP to Handle Your Essure Lawsuit
At Parker Waichman, we understand what you have been through because of your Essure injuries, and we want to help you achieve the justice you deserve. When you hire our firm, you are placing your case in experienced hands. Parker Waichman has been advocating for victims of medical device injuries for decades, garnering numerous awards and accolades along the way.
Some of our proudest honors include:
- A rating of 9.8 (out of a perfect 10) from AVVO, a service that rates every attorney in the United States
- The top peer-review rating, “AV Preeminent,” from Martindale-Hubbell, a company that has rated attorneys across the United States and around the world for more than 100 years based on feedback from judges and peers
- The highest ranking of “5 Dragons” based on peer review by Lawdragon
- Listing in Best Lawyers, determined by extensive peer review
If you or a loved one received an Essure implant and developed a complication related to the device, contact our office today to find out if you might be eligible to file an Essure lawsuit against its manufacturer, Bayer.
What is an Essure Implant?
Essure is a medical device designed for permanent pregnancy prevention. The device is a small, flexible metal coil that is implanted in a woman’s fallopian tube to prevent eggs from being fertilized.
What is an Essure Implant Made of?
The coil has two layers: One layer is stainless steel, and the other layer is made of a nickel titanium-alloy. The two are wound in synthetic fibers.
How Is the Essure Procedure Done?
Essure is implanted hysteroscopically without the need for surgical incisions. A coil is inserted through the vagina and cervix into each fallopian tube. After implantation and throughout the following three months, tissue grows into and around the Essure coils, which is supposed to form a solid barrier that neither an egg nor sperm can pass through. Essure is designed to be permanent and prevent a woman’s eggs from descending and sperm from reaching them for the remainder of her childbearing years. However, Essure can cause severe injuries in women who have it implanted.
Essure FDA Reports and Warnings
Essure was approved for market in 2002, and since that time, patients, doctors, and the manufacturer have reported adverse events and complications to the U.S. Food and Drug Administration (FDA). While the FDA did not force the withdrawal of the device from the market, it did issue safety announcements and required labeling updates for Essure.
In February 2016, the FDA announced that it intended to require Bayer to change its Essure label to include a black-box warning. A black-box warning is the strongest possible warning that can be placed on a drug or medical device. It highlights the most serious risks inside of a thick black box on the top of a drug or device label to call doctors’ and patients’ attention to severe risks.
After receiving preliminary information from an FDA Advisory Committee on the risks and benefits of Essure, the FDA felt that a black-box warning would be appropriate to alert patients and doctors to the potential serious complications of using Essure. However, it was not until October 2016 that the FDA actually followed through on that order. At this time, the FDA ordered Bayer to include a black-box warning on its Essure label stating the following:
“WARNING: Some patients implanted with the Essure System for Permanent Birth Control have experienced and/or reported adverse events, including perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions. If the device needs to be removed to address such an adverse event, a surgical procedure will be required. This information should be shared with patients considering sterilization with the Essure System for Permanent Birth Control during the discussion of the benefits and risks of the device.”
This warning was prompted in large part by the influx of negative information the FDA obtained regarding Essure since it had been approved. The FDA received nearly 15,000 reports of adverse events and complications related to Essure between November 2002 and December 2016, including:
- 10,746 reports of abdominal or generalized pain
- 5,377 reports of heavy menses or menstrual irregularities
- 4,396 reports of headaches or migraines
- 3,560 reports of fatigue
- 3,270 reports of weight fluctuations
- 2,402 reports of patient-device incompatibility (such as an allergy to nickel)
- 1,485 reports of device migration
- 663 reports of the device operating differently than expected
- 617 reports of device breakage
- 304 reports of difficulty removing the device
- 257 reports of difficulty inserting the device
- 4 reports of death of the female patient related to the device
- 21 reports of death of a fetus
- 1,077 reports of unintended pregnancy with the device in place
- 474 reports of pregnancy losses
These reports are extremely alarming and indicate that while the black-box warning was a necessary action, it was not enough to prevent harm to additional women. When you hire Parker Waichman to represent you in your Essure case, you are not only seeking justice for yourself, you are also seeking a safer environment for women in the future.
Complications and Injuries From Essure Birth Control Coils
Bayer touted Essure as a less-invasive alternative to surgical sterilization or tubal ligation. For women who are certain they no longer want children, Bayer advertised that Essure was a safe and effective option for permanent birth control without the necessity for potentially dangerous surgeries.
Although Essure can be implanted easily, it presents even greater dangers than surgery. In fact, studies show that Essure is no better at preventing pregnancies but is ten times more likely to lead to the need for a repeat procedure than tubal ligation. In other words, women who chose surgical sterilization were at a ten times lower risk of needing another surgery than women who chose Essure.
Essure can also lead to severe medical complications. In our experience litigating Essure cases, we have heard clients report a number of serious injuries from the device, many of which required subsequent surgeries and invasive medical treatment. Our clients have described the following complications from Essure:
Many patients develop infection after having the Essure coils implanted. These infections are sometimes minor, resolving with antibiotics, or can be ongoing, requiring further medical treatment.
Chronic Pelvic Pain
Numerous women report experiencing chronic pain in the pelvic region after receiving Essure implants. They feel pressure, tugging, poking, and aching sensations that do not resolve after surgery.
After implantation, the Essure coils can move inside the fallopian tubes, traveling further down the fallopian tubes or into the cervix or uterus, leaving women at risk of additional injury.
The metal coils can poke through or perforate the soft tissue of the fallopian tubes, causing painful complications and potential damage to other organs.
Several women experience an allergic reaction to the nickel in the Essure coils. The reaction can cause rashes, itching, pain, and inflammation, likely the result of nickel corrosion.
A number of women end up having unintended pregnancies after receiving Essure implants, some of which are dangerous ectopic pregnancies (a pregnancy in which a fertilized egg attaches outside of the uterus, also commonly known as “tubal pregnancy”). Pregnancies outside of the uterus cannot be carried to term and can be life-threatening.
Some women experience an autoimmune response after having Essure implanted, which can manifest as fatigue, weight gain, rashes, and/or hair loss.
Especially in the case of ectopic pregnancies, women who become pregnant with Essure implanted often experience fetal death. This can be incredibly traumatic in addition to causing pain, bleeding, and infection.
Many women experience intense migraines, both with and without aura, after receiving Essure implants.
Weight Gain and Fatigue
Though Essure is not a hormonal implant, it can cause hormonal disturbances in women who receive it. This can include weight gain and chronic fatigue.
Particularly when the Essure device has migrated into or past the uterus, women can experience pain during sexual intercourse, a condition medically referred to as “dyspareunia.”
Immediately after implantation and often long thereafter, women with Essure implants report experiencing irregular bleeding, including heavy periods and bleeding in between periods.
Some of the complications associated with Essure become so serious that they can lead to death.
Essure Injuries Impact the Quality of Life for Women
Several of these complications require surgery to remove the Essure implants, which sometimes cannot be accomplished without performing a hysterectomy that includes removal of the ovaries and fallopian tubes. Removal of the ovaries then sends women into premature menopause. Women have reported that their Essure injuries have severely interfered with their quality of life and affected their relationships.
We know your Essure complications have greatly changed your life, and we want to hold Bayer accountable for the ways you have been injured. Our compassionate medical device lawyers will file an Essure lawsuit and ensure that your voice is heard. We will fight for the compensation you deserve.
Statute of Limitations Considerations
Every state has a time limit by which lawsuits must be filed. These time limits are referred to as statutes of limitations and can bar a person’s claim forever if it is not filed in the correct amount of time. States enact statutes of limitations to encourage people to act quickly after an injury, as quicker action tends to result in higher-quality evidence for trial. For instance, people’s memories of a certain event will be much more reliable one year after it happens versus five years after it happens. Filing a lawsuit sooner also increases the likelihood that medical records and business documents will still be intact and retrievable. Additionally, states do not want to place potential defendants in situations where they have to anticipate lawsuits forever.
Every state sets its own individual statute of limitations on every type of legal claim, and they can vary greatly. For instance, the state of Missouri has a two-year statute of limitations on medical malpractice claims but a five-year statute of limitations on product liability claims. Calculating the statute incorrectly can be extremely costly.
Many states also have what are called “discovery rules,” which can give someone a longer time to file a lawsuit by delaying the statute of limitations until the time that they know or should know that they are injured. Some discovery rules even allow a person enough time to decipher why they were injured and by whom. For example, New Jersey and Florida recognize discovery rules, but New York does not.
Another important consideration is when the metaphorical “clock” for the statute of limitations began. In a pending Essure lawsuit, a Philadelphia judge ruled that the statute of limitations does not begin to take effect until a doctor has verified that complications and injuries are the results of the Essure implant. This ruling has created a favorable precedent for plaintiffs in future lawsuits against Bayer and gives plaintiffs more time to find the right legal representation.
Calculating the Statute of Limitations in Your Case
The statute of limitations for an Essure lawsuit will vary depending on the laws of the state you live in. You’ll also need to factor in whether or not your state has a discovery rule. In some states, the clock on your claim starts when you’re injured, but in others, it starts when you discover your injury and its source.
Calculating the statute of limitations for an Essure lawsuit takes investigation and a command of state law. The best way to be sure about the correct statute of limitations for your Essure birth control lawsuit is to work with an experienced medical device lawyer. When we sign up a case at Parker Waichman, we immediately go to work pinning down the appropriate statute of limitations and preserving all relevant evidence to make sure that we have time to file a lawsuit and have everything we need to build the best possible case. If you suffered an injury after having an Essure device implanted, contact our office today for a free case evaluation.
Am I Eligible to File an Essure Lawsuit?
If you have been implanted with Essure and experienced harmful side effects, you may be eligible to file an Essure lawsuit.
At Parker Waichman, we know you are looking for expedient answers about your potential Essure claim. After signing with our firm, our skilled legal team will begin investigating your claim right away to determine whether you are eligible to file an Essure birth control lawsuit against Bayer. During our preliminary investigation, we will do the following:
- Obtain a detailed account of your Essure implantation and injuries
- Order medical records that document your Essure implant lot number
- Order records documenting your Essure injuries and the treatment you received related to those injuries, including any subsequent surgeries
- Identify the governing statute of limitations for your claim (the state-determined time during which you must file your lawsuit)
Preparing Your Essure Birth Control Claim
If this preliminary investigation determines that you have a viable claim, we will move to the next phase, which will include:
- Consulting with medical experts and industry experts to obtain support for your claim
- Determining where your case should be filed (whether in a multidistrict litigation or elsewhere)
- Drafting and preparing a petition for filing
- Completing written discovery or plaintiff profile forms/plaintiff fact sheets
- Reviewing electronic and written discovery from the defendants
- Conducting or reviewing depositions
- Participating in court hearings
- Meeting court-ordered deadlines
- Exchanging records with the defendants
- Participating in potential settlement negotiations
- Carrying out any possible settlement agreement applicable to your claim
When you work with the dedicated attorneys at Parker Waichman, you will always have up-to-date information about the progress of your individual case and the Essure litigation as a whole. We want to make sure you always understand what is happening with the lawsuit and feel confident about where your case is headed. Our team will be by your side the whole way, and we will work together toward the best possible resolution for you and your family.
Frequently Asked Questions About Essure
During the case-signing process, our potential Essure birth control lawsuit clients usually have several questions about the device and the lawsuits against Bayer. Our staff and lawyers have researched these devices extensively, and we will always have current, accurate information for you about the status of the litigation. Below are the most common questions we hear about Essure, along with our answers to those questions.
How Does Essure Work?
The coil has two layers, one stainless steel and one nickel titanium, and is wound in synthetic fibers. Essure is implanted hysteroscopically, or through the vagina and cervix into the fallopian tube. A separate coil is implanted in each fallopian tube.
After implantation, tissue grows into and around the Essure coils, which is supposed to form a solid barrier that neither an egg nor sperm can pass through. Essure is designed to permanently prevent a woman’s eggs from descending and sperm from reaching them.
Who Is the Essure Manufacturer?
Essure was originally developed by Conceptus Inc. Bayer AG bought Conceptus in June 2013 and became the new manufacturer of Essure.
Why Was Essure Discontinued and Removed From the Market?
After the FDA made it mandatory for Bayer to print a black-box warning on the Essure packaging, sales numbers steadily decreased, and the company claims this was the reason for discontinuing the product.
What Are the Long-Term Side Effects of Essure?
According to the FDA, the Essure birth control implant has been linked to many long-term side effects and serious reactions, including:
- Weight changes
- Hair loss
- Allergic reactions
- Mood changes
- Joint or muscle pain
- Muscle weakness
What Other Symptoms and Injuries Can Essure Cause?
In our experience litigating Essure cases, we have heard clients report a number of serious injuries from the device, many of which require subsequent surgeries and invasive medical treatment. Complications can include:
- Serious Internal Infections
- Chronic Pelvic Pain: A feeling of pressure, tugging, poking, and/or aching that does not resolve after surgery
- Migration: After implantation, the Essure coils can travel further down the fallopian tubes or into the cervix or uterus, leaving women at risk of injury.
- Perforation: The coils are made with nickel and could potentially perforate the soft tissue of the fallopian tubes and cause damage to other organs.
- Allergic Reactions: Many allergic reactions to the nickel in the Essure coils have been reported, causing rashes, itching, pain, and inflammation, likely the result of nickel corrosion.
- Ectopic Pregnancy or Miscarriage: Many reports of unintended pregnancies after receiving Essure implants have been reported, some of which have been dangerous ectopic pregnancies. Ectopic pregnancies occur when a fertilized egg attaches outside of the uterus. Pregnancies outside of the uterus cannot be carried to term.
- Autoimmune Response: Some women have experienced an autoimmune response after having Essure implanted. Symptoms include fatigue, weight gain, rashes, and hair loss.
- Fetal Death: This can be incredibly traumatic in addition to causing pain, bleeding, and infection.
- Migraines: Some women have experienced intense migraines after receiving Essure implants.
- Weight Gain and Fatigue: Even though Essure is not a hormonal implant, Essure could cause hormonal disturbances.
- Painful Intercourse
- Irregular Bleeding: Woman who have Essure implants have reported experiencing irregular bleeding, including heavy periods and bleeding in between periods.
- Death: A few of these complications can be so serious that they lead to death.
Several of the most serious complications require surgery to remove the Essure implants, which sometimes cannot be accomplished without performing a hysterectomy that includes removal of the ovaries and fallopian tubes. Removal of the ovaries then sends women into premature menopause. Women report that their Essure injuries have severely interfered with their quality of life and affected their relationships.
Can You Gain Weight From Essure?
Yes. According to the FDA, weight gain is a possible side effect of the Essure birth control implant device.
What Year Did Essure Come Out?
Essure was released in the U.S. in 2002.
How Many Years Does Essure Last?
If implanted correctly, Essure is supposed to be permanent.
Is Essure Hormone-Free?
Yes, Essure is hormone-free.
What Is the Percentage Chance of Getting Pregnant With Essure?
FDA research has shown that within five years of having Essure implanted, there is a less than 1% chance of becoming pregnant. However, other researchers found that within ten years, there was a 9.6% chance of becoming pregnant.
How Effective Is Essure After 10 Years?
Little research has been done on the effectiveness of Essure after ten years, but studies have found Essure to be at least 90.4% effective overall.
Does Essure Affect Your Menstrual Cycle?
When working properly, Essure does not affect the menstrual cycle.
What Happens if You Get Pregnant With Essure?
If you become pregnant with Essure implanted, there is a chance that the fertilized egg could attach outside of the uterus. When this happens, it can pose serious health risks to the mother and the pregnancy is incapable of being carried to term.
How Much Does Essure Cost?
The cost of the Essure procedure can range from $500 to $2,500.
Is There a Recall on Essure?
Although the product was discontinued on Dec. 31, 2018, there was no recall for Essure.
Is Essure Banned in the U.S.?
There is no official ban on Essure, but Bayer did voluntarily remove the product from the market.
Is Essure Available in Canada?
No, Essure is no longer being sold in Canada.
How Do I Know if My Essure Has Migrated?
If your Essure device has migrated, there will likely be a change in your menstrual cycle. Sometimes heavier periods or no periods at all can indicate that the device has moved. Any question as to whether your Essure device has migrated should be answered by your doctor.
Can the Essure Coils Fall Out?
Essure devices that have been improperly implanted do have a chance of being expelled from the body.
Can You Have an MRI With Essure Coils?
Those with Essure coils implanted can have an MRI done with a magnetic strength of up to 1.5 T.
Can You Get Essure Removed?
Yes, you can have Essure removed, but this will usually entail a surgical procedure, possibly even a hysterectomy.
Will Medicaid Pay for Essure Reversal?
No. The procedure can sometimes cost more than $10,000, and government-aided programs such as Medicaid do not cover it.
Can I Have a Baby After Essure?
If the Essure implants are surgically removed, it’s possible that you may be able to get pregnant, but it depends on the type of surgery that’s performed. In many cases, Essure removal will require a hysterectomy, rendering the patient incapable of pregnancy.
What Is an Essure Lawsuit Based On?
An Essure birth control lawsuit typically claims that the device’s manufacturer, Bayer, did not properly make the public aware of serious and long-term side effects that the product could cause. Thousands of women have made claims against Bayer in an attempt to recover damages for the pain and suffering Essure caused them.
What’s the Essure Lawsuit Status Update?
In 2020, Bayer agreed to pay out $1.6 billion to settle claims made over Essure. In the company’s Aug. 20, 2020, announcement, Bayer said that the settlement would cover about 90% of the roughly 39,000 Essure claims brought so far.
How Much Are Essure Lawsuit Settlements?
Essure lawsuit settlements will be based on the amount of damages you have suffered due to this defective medical device. When you file a claim for damages against Bayer, you can recover compensation for all of the ways you have been harmed, including:
- The cost of medical bills from your surgeries or other treatment related to your injuries
- The cost of future medical bills if you will require additional treatment or surgeries
- Lost wages due to time off from work required because of your injuries
- Recovery for your physical and mental pain and suffering as the result of your Essure implant injuries
- Loss of consortium damages, or damages related to the way your injuries have affected your relationship with your spouse
- Punitive damages, should the judge or jury find that the defendant has engaged in conduct extreme enough that it must be monetarily punished
When you hire our law firm, we will help you calculate the full extent of your economic and noneconomic damages to make sure that you and your family receive the best outcome possible. We know that you deserve to be compensated appropriately, and we will work tirelessly to make that happen.
Is There an Essure Class-Action Suit?
Many of the claims brought against Bayer have been handled on a case-by-case basis, but an Essure class-action suit is not unheard of. For instance, in April 2019, a lawsuit against Bayer from nine different women who were harmed by the Essure fallopian tube implant birth control device was permitted to move forward by a federal judge in Philadelphia.
Why Choose an Experienced
Essure Lawyer for Your Claim?
As skilled product liability litigators, the attorneys at Parker Waichman understand the burdens placed upon you and your family by your Essure injuries, and we are committed to helping you move forward with the compensation you need. Our law firm is ready to investigate your claim and determine whether you can file an Essure lawsuit to hold the manufacturer (Bayer) liable for your injuries.
At Parker Waichman, we are extremely proud of the level of compensation we have secured for our clients: We are one of only a few law firms to obtain more than $2 billion in settlement awards and court verdicts. And we are equally proud of the reputation we have earned nationwide. As we litigate cases throughout the country, our name has become associated with honesty, professionalism, and a passion for advocating for victims’ rights. When you hire our lawyers, you can feel confident that your case is being handled with care by a firm with decades of personal injury litigation experience.
In addition, our attorneys work on a contingency-fee basis, meaning that we will advance the costs of any claim we pursue on your behalf and we’ll only be repaid from a portion of your settlement or jury award. If you get nothing, we get nothing. This is one more way that we aim to make seeking justice as stress-free as possible for you; we know that you have already been through enough, and we want to give you peace of mind as well as skilled representation.
Get a Free Case Review
With No Obligation Today
We recognize how greatly your Essure injuries have affected your life, and the experienced medical device lawyers at Parker Waichman are ready to help you fight for your right to compensation. If you or a loved one had an Essure device implanted and experienced subsequent injury, contact our firm today by filling out our online form or calling 1-800-YOUR-LAWYER (1-800-968-7529) for a free consultation.
Additional Essure Information
Essure News & Lawsuits
New York | Brooklyn | Queens | Long Island | New Jersey | Florida
Call us at: 1-800-YOURLAWYER (800-968-7529) | Schedule your free consultation
Have you or a loved one has suffered serious side effects from using Essure birth control?Click To Get A Free Case Review