Dozens of deaths and tens of thousands of injuries are finally leading to action against Bayer. Bayer acquired Conceptus, which was the business originally manufacturing and distributing Essure. Essure is a sort of implanted birth control that creates scar tissue in the fallopian tubes. Our San Diego Essure lawsuit attorneys are aware though the design and implantation of the device have had a significant impact on women worldwide.
Regrettably, the apparatus can pose serious risks, and Bayer failed to notify its consumers and the medical community accurately. When working with defective drug and medical device lawyers, you can find out more about the aspects of this device design and implantation, which affect your case. We can help you file a claim for compensation.
If you suffered complications from this device or even lost a loved one, call us today at 855-938-0980 for a free consultation. We will assess your case and discuss your legal options.
What Is Essure?
Essure is a permanent birth control device intended to take the 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 essentially block the fallopian tubes. These devices sit inside the uterus at the entrance to the fallopian tubes and make scar tissue. The scar tissue was meant to block the fallopian tube and prevent fertilization when an egg descends.
The defect which has led to Essure suits is that the design makes it very easy for these devices to break apart and migrate. When an Essure device would break, it would begin moving throughout the woman’s reproductive organs. Most injuries associated with Essure lawsuits include punctures of the uterus and fallopian tubes in addition to the many complications that result from these injuries.
What’s the Goal of Essure?
Conceptus, Inc. currently owned by Bayer, established this birth control device for many reasons, namely women’s right to alternative birth control choices. In 2002 the United States of America approved the usage of Essure. The process which led to this quick approval is presently under scrutiny. The pre-market approval procedure might have caused the flaws in Essure’s layout to go undetected.
More than 750,000 devices were implanted and sold worldwide. The procedure for implantation takes about 10-minutes and does not need any surgery, incision, or general anesthesia.
The objective of a non-hormonal and long-term implant that does not require surgery was to give a long-term birth control alternative for people who need not want surgery or couldn’t undergo the procedure. The elastic metal coils of nickel and titanium could be placed into the patient’s vagina and then cervix. Once planted into the fallopian tubes, then the tissue would grow over and around the device to block the tube. This congestion ensures any sperm will not be able to access an egg, preventing conception.
The blockage takes around three months to form, and then, a radiologist will carry out a test. This evaluation is to check the congestion is complete and dependable. The evaluation allows patients to know that they might rely on Essure. After the patient goes in for the test, they will receive a shot through the cervix of a dye which would then become visible during an x-ray. The x-ray would affirm the congestion if no dye passed beyond the Essure device.
By the time when Essure became available in 2002, the acceptance of the apparatus depended upon the promise of prospective studies. These future research were never finished nonetheless, the widespread usage of those devices has revealed a number of findings set of the research.
Conceptus, Inc. had received over 30,000 complaints or formal reports by the consumer over its first ten years of use. Failing to warn the general public about those problems is a major component in Essure suits.
Bayer, the present Essure manufacturer, claims that the device is 99.84% successful at preventing pregnancy. But, Contraception, a journal for the field, states that these claims are tremendously inflated. Any variety of factors surrounding implantation can affect the risk of an unplanned pregnancy. A non-perfect placement of the device can result in incomplete blockage and sudden pregnancy.
Conceptus is not able to supply clear statistics on usage as they only surveyed their patients between the ages of 22 and 44. Additionally, there was no follow-up following a last-minute window.
Real-world data has shown that the potency of the Essure device is someplace between 91 and 99 percent with about 9.6% of women becoming pregnant over seven decades of the implantation.
Lawsuits Against Essure
More than 16,000 suits were filed against Bayer and Conceptus Inc. The plaintiffs are all women who suffered abdominal harm from the birth control apparatus. The injuries happened because the implant fractured or broke and then moved throughout the reproductive organs.
Lawyers are arguing that if the doctors and patients involved have been properly informed of the dangers, they’d have chosen an alternative form of birth control.
What Are Some Risks From Essure?
The FDA was able to gather some information concerning the dangers associated with Essure. Short-term risks might contain back discomfort, vaginal bleeding, pain, and cramping.
However, long-term dangers are a lot more severe. These risks include:
- Unintended pregnancy
- Migration of the device
- Allergic reaction to the device
- Autoimmune disease symptoms
- Joint pain
As the Essure implant fractures and moves, it is likely the patient will require a number of surgeries. Not only will the removal of this device be more invasive, but it might require a hysterectomy. Often women opted to use Essure in the attempt of preventing the removal of the uterus.
Many 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 related to Essure implants include heavier menstruation or menstruation irregulates, headaches, weight fluctuation, pain, apparatus breakage, and motion of the apparatus.
The FDA has discovered at least 18 miscarriages directly resulting from Essure. Private firms have seen as many as 300 reports of miscarriages resulting from Essure devices.
Essure Warnings & Recalls
In 2015, the FDA 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. Specifically, Bayer would have to run a surveillance study about the dangers and advantages of Essure’s usage.
In November of 2016, the FDA took further action requiring Bayer to place a black box all their packages for Essure with a warning regarding perforation, abdominal pain, and other complications.
In April 2018, the FDA restricted the sales of Essure to health care suppliers who agreed to educate their patients on the apparatus and its risks fully. In July, Bayer announced it would stop selling Essure.
Why Have Women Filed Claims Against Essure?
There are two primary kinds of injuries associated with Essure devices.
Additional Surgery Beyond Implantation
Women reported picking Essure to avoid an operation, and the implantation has rather led to multiple surgeries due to complications. There’s a common surgical complication such as the failure of appropriate implant positioning, ripping of organs, movement, migration, as well as the need for hysterectomy. The materials supplied to patients prior to the implant didn’t provide adequate details about the complications associated with the Essure layout. Physicians were equally uninformed.
Women have reported significant harms associated with Essure, including metal toxicity, pelvic pain, inflammation, and immune responses. If you experience continued pain following the implantation of an Essure device, you most likely have a claim if you had to see a physician because of the pain associated with the augmentation you likely had an odd reaction.
What Compensation Can I Get From a San Diego Essure Lawsuit?
If the Essure device has caused an accident, you will probably receive some kind of compensation if you look for legal recourse. When submitting a lawsuit against Bayer, you will seek compensation for:
- Past and future pain in addition to suffering that resulted from the defective device
- Wage loss in the event that you missed work for treatment associated with the Essure device
- Economic losses associated with your injuries
How Much Could I Get Out of My Settlement?
There aren’t currently any huge group settlements from Essure manufacturers Conceptus, Inc. or Bayer. This type of lawsuit can take years to resolve, and it might rely on teams of attorneys working with countless dollars to pin down precisely what occurred. Furthermore, these lawyers will frequently have to show the way the situations could have been prevented.
Usually, large groups won’t operate together for a single settlement until a couple of instances have gone through, and both the sufferers and the company understand the risks.
Contact Our Essure Lawyers for a Free Consultation
If you have had problems after getting an Essure implant, take the correct actions to get legal representation. By working with medical experts and lawyers who are knowledgeable about personal injury and product liability, you might have a solid case against Bayer.
Don’t delay, contact Class Action Lawyer Coalition. When calling our law offices at 855-938-0980, you will receive a free consultation from lawyers who focus on faulty medical devices. Find out more about what your situation is worth and how to best prepare for your lawsuit.