Dozens of deaths and tens of thousands of injuries are finally leading to some action against Bayer. Bayer acquired Conceptus, which was the company originally manufacturing and distributing Essure. Essure is a form of implanted birth control that creates scar tissue in the fallopian tubes. Essure lawsuit lawyers are all too aware though that the design and implantation of the device have had a significant impact on women worldwide.
Unfortunately, the device can come with serious risks, and Bayer failed to inform its consumers and the medical community accurately. When working with defective drug and medical device attorneys, you can learn more about the aspects of the device design and implantation, which affect your case.
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What is Essure?
Essure is a permanent but non-surgical birth control device. The idea is that permanent birth control would stand in place of surgical procedures such as ‘tube tying’ and offer a safer method of life-long birth control.
By design, Esssure uses titanium fiber and nickel coils to essential block the fallopian tubes. These devices sit within the uterus at the entrance to the fallopian tubes and create scar tissue. The scar tissue was meant to block the fallopian tube and fervent fertilization when an egg descended.
The flaw which has led to Essure lawsuits is that the design makes it quite easy for these devices to break apart and wander. As an Essure device would fracture, it would begin moving throughout the woman’s reproductive organs. Most injuries related to Essure lawsuits include punctures of the uterus and fallopian tubes as well as the many complications which come with these injuries.
What is the Purpose of Essure?
Conceptus, Inc. now owned by Bayer, created this birth control device for many reasons, namely women’s right to choose birth control alternatives. In 2002 the United States approved the use of Essure. The process which led to this quick approval is currently under scrutiny. The pre-market approval process may have caused the flaws in Essure’s design to go unnoticed.
Over 750,000 devices were sold and implanted worldwide. Essure is non-hormonal and meant to serve as a long-term birth control option. The procedure for implantation takes about 10-minutes and does not require any surgery, incision, or even general anesthesia.
The purpose of a non-hormonal and long-term implant that does not require surgery was to give a long-term birth control solution for those who wanted to avoid surgery or could not undergo the procedure. The flexible metal coils of nickel and titanium would be inserted into the patient’s vagina and then cervix. Once planted into the fallopian tubes, the tissue would grow over and around the device to block the tube. This blockage ensures that any sperm won’t be able to access an egg, preventing conception.
The blockage takes about three months to form, and afterward, a radiologist will perform a test. This test is to check that the blockage is complete and reliable. The test allows patients to know that they could rely on Essure. When the patient goes in for the test, they will receive an injection through the cervix of a dye which would then become visible during an x-ray. The x-ray would confirm the blockage if no dye leaked past the Essure device.
From the time when Essure became available in 2002, the approval of the devices relied on the promise of future studies. These future studies were never completed; however, the widespread use of these devices has revealed a number of findings in place of the studies.
Conceptus, Inc. had received over 30,000 complaints or formal reports from the consumer within its first ten years of use. However, even with this onslaught of problems, they did not notify the FDA, the medical community, or their consumers. Failing to warn the general public about these problems is a major component in Essure lawsuits.
Bayer, the current Essure manufacturer, claims that the device is 99.84% effective at preventing pregnancy. However, Contraception, a journal for the field, states that these claims are exceptionally inflated. Any number of factors surrounding implantation can impact the risk of an unplanned pregnancy. A non-perfect placement of the device can lead to incomplete blockage and unexpected pregnancy.
Conceptus is unable to provide clear statistics on use as they only surveyed their patients between the ages of 22 and 44. Additionally, there was no follow-up after a five-year window.
Real-world data has shown that the effectiveness of the Essure device is somewhere between 91 and 99% with about 9.6% of women becoming pregnant within ten years of the implantation.
Lawsuits Against Essure
Over 16,000 lawsuits were filed against Bayer and Conceptus Inc. The plaintiffs are all women who suffered abdominal damage from the birth control device. All damage was done because the device fractured or broke and then moved throughout the reproductive organs.
Attorneys are arguing that if the doctors and patients involved were properly informed of the risks, they would have chosen an alternative form of birth control. Other options such as tubal ligation, tubal fulguration, salpingectomy, hysterectomy, or the application of clips are all long-term birth control options.
What Are Some Risks From Essure?
The FDA has been able to gather some information about the risks associated with Essure. Short-term risks might include back discomfort, vaginal bleeding, pain, and cramping.
However, long-term risks are far more severe. These risks include:
- Unintended pregnancy
- Ectopic pregnancy (pregnancy outside the uterus which can be fatal)
- Migration of the device
- Puncture of the uterus or fallopian tubes
- Allergic reaction to the device
- Autoimmune disease symptoms
- Joint pain
As the Essure implant fractures and moves, it’s likely that the patient will require multiple surgeries. Not only will the removal of the device be invasive, but it may require a hysterectomy. Often women chose to use Essure in the effort of avoiding the removal of their uterus.
Because the FDA had received over 26,000 reports of Essure failure between 2002 and now they have taken action against the devices. Most reports have come from women who voluntarily spoke out against the Essure device they elected to have implanted with the understanding that it was safe.
Common problems associated with Essure implants include heavier menstruation or menstruation irregulates, headaches, weight fluctuation, pain, device breakage, and movement of the device.
The FDA has found at least 18 miscarriages directly resulting from Essure. Private firms have found as many as 300 reports of miscarriages resulting from Essure devices.
Essure Warnings & Recalls
The FDA first took action in September of 2015 when they arranged a meeting with the Obstetrics and Gynecology Devices Panel within the Medical Devices Advisory Committee. They discussed scientific and clinical opinions, patient experiences, and more regarding the Essure device. The result was that the FDA ordered Bayer to survey their market. Specifically, Bayer would need to conduct a surveillance study about the risks and benefits of Essure’s use.
In November of 2016, the FDA took further action requiring Bayer to place a black box on all their packages for Essure with warning about perforation, abdominal pain, and other complications.
2018 has brought significant movement against Conceptus and Bayer. First, in April, the FDA restricted the sales of Essure to medical providers who agreed to educate their patients on the device and its risks fully. Then in July, Bayer announced that it would end all sales of Essure.
Who Files Claims Against Essure?
There are two primary types of injuries associated with Essure devices.
Additional Surgery Beyond Implantation
Women reported choosing Essure to avoid surgery, and the implantation has instead led to multiple surgeries because of complications. There is a widespread surgical complication such as the failure of proper implant placement, tearing of organs, movement, migration, and even the need for hysterectomy. The materials provided to patients prior to the implant did not provide adequate information about the complications associated with the Essure design. Doctors were equally uninformed.
Unusual Reactions Also Led to Essure Lawsuits
Women have reported significant injuries associated with Essure, including metal toxicity, pelvic pain, inflammation, and immune reactions. If you experience continued pain after the implantation of an Essure device, you probably have a claim if you needed to see a doctor because of the pain associated with the implant you likely had an unusual reaction.
Can I Get Compensation if I File a Lawsuit Against Essure?
If the Essure device has caused injury, you will likely receive some form of compensation if you seek legal recourse. When filing a lawsuit against Bayer, you will seek damages for:
- Past and future medical bills
- Past and future pain as well as suffering which resulted from the defective device
- Wage loss if you missed work for treatment associated with the Essure device
- Economic losses associated with your injuries
- Punitive damages, when appropriate
How Much Can I Get From My Settlement?
There are not currently any large group settlements from Essure manufacturers Conceptus, Inc. or Bayer. This type of litigation can take years for resolve, and it may rely on teams of lawyers working with millions of dollars to pin down exactly what happened. Additionally, these lawyers will often need to show how the situations could have been prevented.
Usually, large groups will not work together for one settlement until a few cases have gone through, and both the victims and the company understand the risks.
Contact an Essure Lawyer for a Free Consultation
If you have had problems after Essure implantation, take the proper steps to obtain legal representation. An Essure lawsuit lawyer can help you prepare for your case from start to finish. By working with medical experts and attorneys familiar with personal injury and product defects, you can have a strong case against Bayer.
Don’t delay, contact the Law Offices of Dalimonte Rueb Stoller. When contacting our law offices, you’ll receive a free consultation from attorneys who specialize in defective medical devices. Learn more about what your case is worth and how to best prepare for your lawsuit.