Dozens of deaths and thousands of accidents are finally leading to some action against Bayer. Bayer obtained Conceptus, which was the company originally manufacturing and distributing Essure. Essure litigation attorneys are all too aware though the design and implantation of this apparatus have had a substantial effect on women globally.
Regrettably, the device can include serious risks, and Bayer failed to notify its consumers and the medical community accurately. When working with faulty drug and medical device attorneys, you can find out more about the facets of this device design and implantation, which affect your situation.
Contact our class action lawyers today for a free case review and find out how we can help you get the compensation you deserve with a Washington DC Essure lawsuit.
What is Essure?
Essure is a permanent but noninvasive birth control device. The notion is that permanent birth control would endure instead of surgical procedures such as tube tying and provide a safer means of long-term birth control.
By design, Esssure employs titanium nickel and fiber coils to crucial block the fallopian tubes. These devices sit within the uterus in the entrance into the fallopian tubes and create scar tissue. The scar tissue was meant to block the fallopian tube and excited fertilization as soon as an egg straightened.
The flaw that has led to Essure lawsuits is that the layout makes it very easy for all these devices to split apart and wander. As an Essure device would fracture, it might begin moving throughout the woman’s reproductive organs. Most injuries related to Essure suits include punctures of the uterus and fallopian tubes in addition to the numerous complications that arrive with these injuries.
What’s the Goal of Essure?
Conceptus, Inc. now owned by Bayer, created this birth control device for many reasons, namely women’s right to choose birth control choices. In 2002, the United States approved the use of Essure. The process which resulted in this quick approval is currently under scrutiny. The pre-market approval procedure may have caused the flaws in Essure’s design to go undetected.
Over 750,000 devices were implanted and sold worldwide. The process for implantation takes about 10-minutes and doesn’t need any anesthesia, anesthesia, as well as general anesthesia.
The purpose of a non-hormonal and long-term augmentation that doesn’t want surgery was supposed to give a long-term birth control solution for people who wanted to avoid surgery or couldn’t undergo the process. The flexible metal coils of nickel and nickel would be inserted into the patient’s vagina and then cervix. Once planted into the fallopian tubes, the tissue would grow over and about the device to obstruct the tube. This congestion ensures any sperm will not have the ability to access an egg, preventing conception.
The blockage takes about three months to form, and then, a radiologist will carry out a test. This test is to check the congestion is complete and dependable. The test allows patients to understand they might rely on Essure. After the patient goes for the evaluation, they are going to receive an injection 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 leaked past the Essure device.
By the time when Essure became available in 2002, the approval of these devices relied on the promise of prospective studies. These future research were never completed; however, the widespread use of those devices has revealed a number of findings in place of the studies.
Conceptus, Inc. had obtained over 30,000 complaints or formal reports from the consumer within its first ten decades of usage. Failing to frighten the general public about these problems is a major component in Essure suits.
Bayer, the present Essure manufacturer, asserts that the unit is 99.84% successful at preventing pregnancy. But, Contraception, a journal for the area, says that these claims are tremendously inflated. Any number of variables surrounding implantation can impact the chance of an unplanned pregnancy. A non-perfect placement of the apparatus can lead to incomplete congestion and sudden pregnancy.
Conceptus is not able to provide clear data on use as they just surveyed their patients between the ages of 22 and 44. Furthermore, there was not any follow-up following a last-minute window.
Real-world data has shown that the effectiveness of the Essure device is somewhere between 91 and 99% with about 9.6percent of women becoming pregnant over seven decades of their implantation.
Lawsuits Against Essure
More than 16,000 lawsuits were filed against Bayer and Conceptus Inc. The plaintiffs are all women who suffered abdominal harm from the birth control apparatus. All damage was done because the apparatus fractured or broke and then moved throughout the reproductive organs.
Lawyers are arguing that if the doctors and patients involved were correctly informed of the dangers, they would have picked an alternative form of birth control. Other selections like tubal ligation, tubal fulguration, salpingectomy, hysterectomy, or even the application of clips are long-term birth control options.
What Are Some Hazards From Essure?
The FDA has been able to collect some information about the dangers associated with Essure. Short-term risks might contain back discomfort, vaginal bleeding, pain, and cramping.
However, long-term dangers are far more severe. These dangers include:
- Unintended pregnancy
- Ectopic pregnancy (pregnancy outside the uterus which can be fatal)
- Migration of this device
- Allergic reaction to the device
- Autoimmune disease symptoms
- Joint pain
As the Essure implant moves and fractures, it is very likely that the patient will require a number of surgeries. Not only will the elimination of this device be more invasive, but it might require a hysterectomy. Often women chose to use Essure in the effort of avoiding the removal of the uterus.
Because the FDA had received over 26,000 reports of Essure collapse between 2002 and now they have taken action against the apparatus. Many reports have come from women who willingly spoke out from the Essure device they elected to have implanted with the knowledge that it was secure.
Common problems related to Essure implants contain thicker menstruation or menstruation irregulates, headaches, weight fluctuation, pain, device breakage, and movement of the device.
The FDA has discovered at least 18 miscarriages directly leading to Essure.
They discussed scientific and clinical opinions, patient encounters, and more concerning the Essure device. Especially, Bayer would need to conduct a surveillance study about the dangers and benefits of Essure’s use.
In November of 2016, the FDA took further actions requiring Bayer to put a black box all their packages for Essure with caution about perforation, abdominal pain, and other complications.
2018 has attracted significant motion against Conceptus and Bayer. In April, the FDA restricted the earnings of Essure to medical providers who agreed to educate their patients on the apparatus and its risks completely. Then in July, Bayer announced that it would stop selling Essure.
Who Files Claims Against Essure?
There are two primary types of injuries associated with Essure devices.
Additional Surgery Past Implantation
Girls reported choosing Essure to prevent operation, and the implantation has rather led to numerous surgeries because of complications. There’s a common surgical complication like the failure of appropriate implant placement, tearing of organs, migration, movement, and even the need for hysterectomy. The materials supplied to patients before the implant didn’t provide adequate information about the complications associated with the Essure layout. Doctors were both uninformed.
Unusual Reactions Also Led to Essure Lawsuits
If you encounter continued pain after the implantation of an Essure device, you most likely have a claim in the event that you had to see a doctor because of the pain associated with the implant you likely had an odd reaction.
In case the Essure device has generated an accident, you will probably receive some form of compensation if you look for legal recourse.
- Past and future pain as well as suffering that resulted from the defective device
- Wage loss if you missed work for therapy associated with the Essure device
- Punitive damages, when appropriate
How Much Can I Get From My Settlement?
There are not currently any huge collection settlements from Essure makers Conceptus, Inc. or Bayer. This sort of lawsuit may take years, and it might rely on teams of attorneys working with millions of dollars to pin down precisely what happened. Additionally, these lawyers often must demonstrate how the situations could have been averted.
Usually, large groups won’t work together for a single settlement until a couple of cases have gone, and both the sufferers and the company understand the dangers.
Get Help Filing a Washington DC Essure Lawsuit
If you have had problems after Essure implantation, take the correct steps to get legal representation. By working with medical experts and lawyers familiar with personal injury and product defects, you can have a strong case against Bayer.
Don’t delay, contact our attorneys now. When calling our law offices, you will receive a complimentary consultation from attorneys who specialize in faulty medical devices. Find out more about what your case is worth and how to best prepare for your suit.