Throughout Washington, D.C. women are reporting issues with Essure the non-surgical, non-hormonal life-long birth control. The dozens of deaths and countless injuries are only a part of the action against Bayer and Conceptus, Inc. As Essure injuries surface, Essure lawsuit lawyers are ready to help the victims of a medical device defect.
If you have had to seek out medical help, surgery, or have had a hysterectomy because of the Essure birth control device, you may have a case. The Dalimonte Rueb lawyers of Washington D.C. are taking on these victims to help them recover full compensation for their pain and suffering.
What is Essure?
Essure is a non-hormonal long-term implant to prevent pregnancy. It does not require surgery, can be implanted at your doctor’s office or a local clinic, and should leave you able to return to your daily routine right away.
For effectiveness. The Essure devices were comprised of two metal coils, one nickel and the other titanium which were wound together. The device would be inserted into the fallopian tubes, and over the course of three months, the tissue would fuse to the device closing the tubes. The blockage would prevent any chance of sperm meeting an egg. About three months after insertion, a radiologist would insert die through the cervix and ensure that the blockage was complete through an x-ray.
As a permanent birth control device, the idea is unique and reasonably effective. However, it’s proven to be a less safe option than surgery or other alternatives. Essentially the blockage of the tubes comes from scar tissue as the device is scaring the area. These devices were fracturing and scaring or scoring other areas of the uterus and fallopian tubes. As the devices fractured, they would move through the reproductive organs and even injury other nearby organs.
What is the Purpose of Essure?
Essure hit the market in 2002 as part of a U.S. pre-market approval process. Essentially it fast-tracked the FDA screening process, and many of Essure’s design flaws went unnoticed because of this. Conceptus created the Essure device hoping to deliver a non-hormonal and non-surgical solution for long-term birth control. The effect, however, has led many women to have a much more permanent birth control option than intended after receiving a hysterectomy as part of their recovery from the Essure device.
Worldwide, about 750,000 devices were sold and then implanted many of those being within the U.S. The procedure for implantation fits the primary purpose in that it provides women with an alternative option to a hysterectomy or tube tying. Essure is essentially two coils, one of nickel and one of titanium that is inserted vaginally through the cervix, and into the opening of the fallopian tubes. The procedure takes ten minutes and has no incision or anesthesia. As a non-surgical option, it was a top choice for many women.
Essure first became available in 2002 after they received pre-market approval with the conditions of conducting further studies. Those studies were never completed or published. Conceptus claims that Essure is 99.84% effective and is safe. However, both claims seem to be quickly disproven.
Findings have shown that over 30,000 complaints have been made to Conceptus regarding their product. These formal complaints spanned from 2002 to 2012, the first ten years of Essure’s availability. Although they began receiving complaints early and frequently, Conceptus did not inform the FDA, the general public, or the medical community. Failing to give doctors proper information about devices and treatments is a major factor in these cases.
Additionally, Conceptus information is extremely unreliable as they only surveyed patients between the ages of 22 and 44 and not outside of five years. Outside data estimates that 9.6% of women will become pregnant within ten years of the Essure implantation and that the effectiveness of the device may be as low as 91%.
Lawsuits Against Essure
There are currently over 16,000 cases open against Bayer and Conceptus, Inc. The plaintiffs involved are almost entirely women who suffered abdominal damage from the device. The damage and injuries come from the device fracturing and moving throughout the uterus and fallopian tubes. Occasionally nearby organs are also affected.
Essure lawsuit attorneys are arguing that doctors and patients did not have accurate information informing them of the risks that come with the use of Essure. The claim is that if the patients and the medical community were fully informed they would not have chosen that form of birth control. Other available options include tubal fulguration, salpingectomy, tubal ligation, clips, and a hysterectomy.
What Are Some Risks From Essure?
Although Essure repeatedly fails to provide information about the risks of the product, the FDA has found substantial research about the many risks. Short-term risks often include vaginal bleeding, general discomfort, pain, and cramping.
Long term risks which are for more severe include:
- Migration of the device
- Fracture of the device
- Unintended pregnancy
- Ectopic pregnancy (which is potentially fatal)
- Puncture of the uterus
- Puncture of the fallopian tubes
- Allergic response
- Autoimmune disease symptoms
- Joint pain
Most injuries come as a result of the device fracturing and them migrating throughout the uterus and fallopian tubes. Usually, the fractured device will require several surgeries to remove, and doctors may choose to remove the entire uterus. A hysterectomy or the removal of the uterus is often the procedure that women were trying to avoid when they chose Essure.
The risks associated with Essure only came to light after the FDA received over 26,000 reports of product defects between 2002 and now. They have taken steps against Bayer, but most women who filed these reports advised that they had no idea about the risks associated with the device.
Other common issues include heavy menstruation, irregular menses, weight fluctuation, device breakage, migration, and pain. The FDA publicly noted that it’d found at least 18 instances of miscarriage because of device failure. Additional firms which work privately state that the figure for miscarriages of unintended pregnancies was closer to 300.
Essure Warnings & Recalls
In September of 2015, the FDA, Food and Drug Administration took their first big step against the Essure product. They set up a meeting with the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee to discuss key elements associated with the Essure implant and the complaints received from consumers. Clinical opinions, scientific opinions, and patient experiences led the FDA to order Bayer to begin a market survey. Bayer was told to survey the risks and benefits of Essure products.
Then in November of 2016, the FDA ordered Bayer to place a black warning box on all of their Essure product’s packaging. The label warned of abdominal pain, perforation, and other complications.
Finally, in 2018, after being ordered to restrict sales to medical providers who agreed to educate their patients, Bayer chose to end the product’s distribution. As of the end of 2018, all Essure sales have ended.
Who Files Claims Against Essure?
Of all those affected, there seem to be two primary groups of people involved in Essure lawsuits. These cases are:
- Additional surgery because of implantation. The larger portion of people is starting lawsuits against Bayer and Conceptus because of the additional medical procedures. Women have needed to undergo multiple surgeries directly because of the Essure implant’s complication. The surgical complication can include failing to properly place the implant, tearing the organs, moving through the reproductive organs, migration, and more. Often the solution is a hysterectomy, which is often what these women were attempting to avoid when choosing Essure. The information made available about the device to doctors and patients did not contain risks which result because of Essure’s design.
- Unusual reactions to the Essure device. The materials used in Essure have incited some severe allergic reactions, as well as metal toxicity, inflammation, immune reactions, and pelvic pain. If you experienced any of these issues first-hand, because of an Essure device, you need to file your claim. Speak with a lawyer if you sought out medical care for the pain associated with an Essure implant.
Can I Get Compensation if I File a Lawsuit Against Essure?
When filing a lawsuit against Essure, you’ll need to seek compensation for specific damages. You can pursue damages for:
- Medical treatment expenses, past, and future.
- Pain and suffering for both physical and mental capacities.
- Economic losses which came as a result of your injuries.
- Lost wages for the time spent recovering from surgery or treatment for your injuries.
- Punitive damages, if appropriate.
How Much Can I Get From My Settlement?
Although Essure has impacted many people, it’s not a large group settlement case yet. These types of cases will often take years to reach a resolution and may depend on teams of attorneys as well as millions invested into the investigation. Before you can get a settlement, lawyers must present the facts of what happened, and determine if it was preventable.
The case against Beyer and Conceptus Inc. is strong but not strong enough to promise everyone affected a flat-rate. The only way you can start working towards a compensation goal is to speak with an Essure lawsuit attorney. Many individual cases will likely go through before there is any class action case.
Contact Our Essure Lawsuit Attorneys for a Free Consultation
Essure implantation was only the first of many painful and troubling procedures. After choosing Essure, many women suffered extensive injuries and needed emergency medical intervention. If you were among those who believed that Essure was safe, you need legal representation. Bayer and Conceptus, Inc. are working to build their case, and you need a lawyer who is willing to stand up to this giant in the medical community.
Contact the law offices of Dalimonte Rueb in Washinton D.C. now for assistance with your case. When you call our offices, you will have the chance to sit down with a lawyer who specialized in medical device cases. Take the chance to learn more about your case and what you should fight for regarding proper compensation.