Have you got a birth control device implanted? Was it Essure? Are you facing complications? If yes, read on to know how you can file Essure lawsuits.
What Is Essure?
Essure is a Class III medical device implanted in women as a birth control device. However, things took a tacky turn when the devices started to cause complications in women. It is moreover a permanent device.
This device was first manufactured by a machine manufacturing company, Conceptus, and got approved by FDA in 2002. The device was later acquired by healthcare giant Bayer in the year 2013. The device was successfully implanted in many women around the US before it was withdrawn from the market in 2018.
Essure is shaped by an elongated coil made of nickel allow and nylon fiber.
Its implantation doesn’t require any surgery and is done manually through the vagina. However, the removal of the device may require surgery. The device is placed in the uterus such that the metal coils are inserted into the fallopian tubes. It works by blocking the fallopian tubes and prevents the fertilized egg from reaching the ovaries.
How Essure Lawsuits Started?
It was in the year 2016 when FDA first gave a black box warning to this device. FDA started receiving medical reports on Essure between 2013 to 2015. These reports were from women who had the device implanted. The number of submitted reports kept on increasing till the year 2020.
In the year 2002, 99% of the reports submitted demanded litigation. By the end of the year 2002, some reports were coded with words like death. The reports included reporting live births, pregnancy loss, ectopic pregnancies, and such reasons, which points out the failure of the device.
Complications of Essure Birth Control Device
Along with the failure of the device to prevent birth control, it also resulted in severe complications in women after the device was implanted. These complications include:
- Fallopian tube Perforation (device cutting through nearby organs)
- Weight gain
- Autoimmune disorders
- Device migration and device fracture
- Coil migration
Many women also reported device removal, citing reasons for pain, genital hemorrhage, suspected allergy to metals, and others.
According to an FDA report, 10% of the device removal reports state that women have complications related to the device removal
Thousands of women have filed Essure lawsuits since Bayer’s device approval. Nearly 40,000 lawsuits are still underway. Even after obvious evidence that highlights the inefficiency of the product, Bayer says he withdrew its product from the market due to a fall in sales and not due to its adverse effects. It hasn’t recalled its products till now.
As per the latest settlement as of August 2020, Bayer announced the settlement amount of $1.6 billion to settle all Essure lawsuits around the US.
According to German drugmaker Bayer’s statements, this amount will cover 90% of the 36000 filed and unfiled claims.
In the year 2016, Bayer also conducted a safety study on FDA orders. Thereafter, Bayer added a warning label to the Essure device starting in 2016. The patient also has to fill a complete checklist warning them of its dangers. It was reported that the sales of the product dropped by 70% since then.
Allegations Against Bayer and Conceptus
If you are also a plaintiff and willing to file an Essure lawsuit, make sure you know what you are fighting for.
Here are some of the allegations made on Bayer and Conceptus under Essure lawsuits:
1. Improper Doctor’s Training
The lawsuits allege that Bayer didn’t train the doctors properly on the use of the device. They also did not verify the doctor and even provided the kit to untrained doctors. It also alleges that they encourage doctors to sell ‘Essure’ to their patients negligently.
2. Failure To Warn
The lawsuits also allege that Bayer failed to warn the FDA of its product’s side effects and did not accept that its product has adverse health effects.
It also failed to disclose the medical reports submitted by women as device complaints.
3. Breach Of Warranty
Lawsuits also sue Bayer for making careless statements and not recalling its product even after complaints.
Contact Our Mass Tort Lawyers Today
If you have the Essure birth control medical device implanted and are suffering from complications, or even if after its removal you are suffering from complications, you can file an Essure lawsuit with the help of a personal injury lawyer.
We can help you file an Essure lawsuit and assist you throughout the process. We will also provide appropriate data on if the case is a class action lawsuit or an individual lawsuit. Contact us today to learn more.