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 manufacturer (Bayer) has disseminated about the device. Women believe they are receiving a simple, safe device that will prevent them from becoming pregnant. Thinking a non-hormonal, nonsurgical option sounds perfect for them, they have Essure implanted. Soon after, however, they discover the device is defective, and their lives have been completely changed because of it.
Why Choose Parker Waichman LLP to Handle Your Essure Lawsuit
At Parker Waichman LLP, 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:
- 8 (out of a perfect 10) Rating by AVVO (a service that rates every attorney in the United States)
- “Preeminent Lawyers” AV Peer Review Rating (Martindale-Hubbell® – a company that, for more than 100 years, has rated attorneys across the United States and the world based on feedback from judges and their peers)
- Highest Ranking of “5 Dragons,” based on peer review by Lawdragon
- Listing in Best Lawyers Publication, 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 the manufacturer Bayer.
What is an Essure Implant?
Essure is a medical device designed for permanent pregnancy prevention. The device, manufactured by Bayer, is a small, flexible metal coil to be 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 is wound in synthetic fibers.
How is the Essure procedure done?
Essure is implanted hysteroscopically without the need for surgical incisions. A coil is implanted through the vagina and cervix into each fallopian tube. After implantation and throughout the course of 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. 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 to date has not withdrawn the device from the market (nor has Bayer performed a voluntary recall), it has issued Safety Announcements and required labeling updates for Essure.
In February 2016, the FDA announced 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.
The above warning was prompted in large part because of 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. The reports can be divided as follows:
- 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 is a necessary action, it is not enough to prevent harm to additional women. Essure needs to be withdrawn fully from the market, and the attorneys at Parker Waichman are fighting to make that happen. When you hire us 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.
Essure Complications and Injuries
Bayer touts Essure as a less invasive alternative to surgical sterilization or tubal ligation. For women who are certain they no longer want children, Bayer advertises that Essure is 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 Essure is no better at preventing pregnancies but 10 times more likely to require a repeat procedure than tubal ligation. In other words, women who choose surgical sterilization are at a 10 times lower risk of needing another surgery than women who choose 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 require 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 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, referred to as “migration,” traveling further down the fallopian tubes or into the cervix or uterus, leaving women at risk for 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 pregnancies”). Pregnancies outside of the uterus cannot be carried to term.
Some women experience an autoimmune response after having Essure implanted, which can manifest as fatigue, weight gain, rashes, and 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 after receiving Essure implants, both with and without aura.
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 the above 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.
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 operate to bar a person’s claim forever if 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 he knows or should know he is injured. Some discovery rules even allow a person enough time to decipher why he was injured and by whom. For example, New Jersey and Florida recognize discovery rules, but New York does not.
Calculating the Statute of Limitations in Your Case
Calculating the statute of limitations on a person’s case takes investigation and a command of state law. The best way to be sure about the correct statute of limitations on your potential Essure claim is to work with an experienced medical device lawyer. When we sign up a case at Parker Waichman LLP, we immediately go to work pinning down the appropriate statute of limitations and preserving all relevant evidence to make sure 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.
Am I Eligible to File an Essure Lawsuit?
At Parker Waichman LLP, 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 to determine whether you are eligible to file an Essure 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 (“product identification”);
- 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 Claim
If this preliminary investigation determines you have a viable claim, we will move to the next phases of your claim, which will include all of the following:
- Consulting with medical experts and industry experts to obtain support for your claim;
- Determining where your case should be filed (whether in 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; and
- Carrying out any possible settlement program applicable to your claim.
When you work with the dedicated attorneys at Parker Waichman LLP, you will always have updated 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 in 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 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.
What is Essure?
Essure is a medical device designed for permanent pregnancy prevention. The device, manufactured by Bayer, is a small, metal coil to be implanted in a woman’s fallopian tubes to prevent eggs from being fertilized.
What Are the Long-term Side Effects of Essure?
According the FDA website, Essure has been linked to many long-term side effects and serious reactions to the implant. The FDA reports these long-term side effects and reaction of the Essure birth control implant:
- Weight changes.
- Hair loss.
- Allergic reactions.
- Mood changes.
- Hypersensitivity reactions.
- Joint or muscle pain.
- Muscle weakness.
How Does Essure Work?
The coil has two layers – one stainless steel, 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 will be implanted in each fallopian tube.
After implantation and throughout the course of 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. Essure is designed to permanently prevent a woman’s eggs from descending and sperm from reaching them.
What Injuries Can Essure Cause?
Even though Essure can be implanted easily, it presents even greater danger than surgical tubal ligation. In fact, studies show Essure is no better at preventing pregnancies but 10 times more likely to require a repeat procedure. In other words, women who choose surgical sterilization are at a 10 times lower risk of needing another surgery than women who choose 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 require subsequent surgeries and invasive medical treatment.
Our clients have described the following complications from Essure:
- Serious Internal Infections
- Chronic Pelvic Pain –A feeling of pressure, tugging, poking, and aching sensations that do 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 for additional injury.
- Perforation – The coils are made with nickel and could potentially poke through or perforate the soft tissue of the fallopian tubes and potential 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 pregnancies or “Tubal Pregnancies” – Many reports of unintended pregnancies after receiving Essure implants have been reported and some of which are 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 – There are some women who 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 experience 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 or “Dyspareunia”
- Irregular Bleeding – Woman who have the Essure implants have reported experiencing irregular bleeding, including heavy periods and bleeding in between periods.
- Death – A few of these complications with Essure can become so serious that they can lead to death.
Several of the above complications require surgery to remove the Essure implants, which sometimes cannot be accomplished without performing a hysterectomy that includes removed 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.
What Kind of Settlement Could I Receive?
When you file a claim for damages against Bayer, you can recover for all of the ways you have been harmed by its device. This includes claims for the following types of compensation:
- The cost of medical bills from your surgeries or other treatment related to your hip implant injuries;
- The cost of future medical bills if you will require additional treatment or surgeries;
- Damages from the time and wages you have missed at work if you have not been able to work because of your injuries. This can include compensation for missed future time and wages if you cannot return to work;
- 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 such that it must be assessed a sum of money carrying a punishing effect.
When you hire our firm, we will help you calculate the full extent of your economic and noneconomic damages to make sure you and your family receive the best outcome possible. We know you need to be compensated appropriately, and we will work tirelessly to make that happen.
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.
Speak With One Of Our Essure Lawyer Today
As skilled product liability litigators, the attorneys at Parker Waichman LLP 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 Essure claim and determine whether you can file an Essure lawsuit to hold the manufacturer (Bayer) liable for your injuries.
At Parker Waichman LLP, 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 achieve more than $2 billion in settlement awards and court verdicts — and we are equally proud of the reputation we have earned nationwide. Fellow plaintiffs’ lawyers, defense lawyers, judges, and former clients have bestowed us with several honors, making us one of the top personal injury and product liability law firms in the country. As we litigate cases throughout the United States of America, 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 your case is being handled with care by a firm with decades of personal injury litigation experience.
Your initial consultation with our firm is absolutely free, and we will generally advance the costs of any claim we pursue on your behalf. We strive to make the process as stress-free as possible because we know you have already been through enough. Contact us today to find out more information about how we can help you and your family.
Contact Parker Waichman LLP For Your Free Case Review
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 by calling 1-800-YOURLAWYER (1-800-968-7529) for a free consultation.
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