Thousands of filed lawsuits against Essure, a medical device to prevent pregnancy, have been ongoing as women wait for verdicts in their favor. Bayer announced that it would pay a large sum to end most of the lawsuits against the company involving Essure. This Essure settlement would take care of most of the claims against the company.
What is the Essure Device?
Essure is a birth control device manufactured by Bayer AG under the subsidiary Conceptus that caused serious health complications in women. Shortly after they began using the device, women complained of severe side effects.
The Essure procedure involves the device being placed into a woman’s fallopian tubes to prevent pregnancy. The US Food and Drug Administration (FDA) had approved the use of Essure in November 2002 after clinical trials.
The Essure Procedure
The product was marketed as a less-invasive alternative to tubal ligation, which is a surgical procedure on the fallopian tubes to prevent conception. The Essure device component could be inserted in 10 minutes in a doctor’s office.
The device consists of Essure coils would be inserted into the fallopian tube where the tissue would grow around it, effectively blocking the tubes. It would take about three months for the tubes to be completely blocked.
By 2009, the product was deemed to be safe after follow-up studies from the time that the FDA approved Essure. However, evidence was beginning to arise behind the scenes with women who had several undesirable adverse events of using Essure that it was a defective medical device.
- Perforations in the fallopian tubes
- Severe pain and bleeding that was persistent
- Unintentional pregnancies
- Some deaths that may be related to the device
Thousands of women began reporting major side effects by 2013 for the Essure birth control device that was meant to be permanent. They often opted to have the device removed.
Many women had hysterectomies to get relief from abdominal pain. For some women, the device came loose entirely while in others it would cause chronic pain when it pierced the walls of the fallopian tubes.
The Start of Essure Lawsuits
Lawsuits were filed against the manufacturers of Essure, seeking compensation for the damage done by the device. It was claimed that the company didn’t disclose the potentially serious side effects of Essure. There was also questioning about the limited testing done for FDA approval.
In the lawsuits filed, plaintiffs claimed that they weren’t given information about the risks associated with Essure medical devices. If they had received the information about the device’s risks, they would have chosen a different form of birth control.
Allegations were made in the Essure cases that the company hid information to receive FDA approval. It was also stated that the company never informed the public about the true risks of using the device.
Litigants claimed that testing was only done for a short time with little follow-up for Essure, which was meant to be a permanent birth control device. Because of the short clinical trials, the true long-term risks couldn’t be known.
FDA Changes for Essure
Amid all the lawsuits that were filed from the Essure plaintiffs on these medical devices, the FDA set new guidance for the product. The FDA required Bayer to ensure that Essure carried a black box warning on its label, which would alert users to the common and significant adverse effects associated with the device.
Those risks must be provided to the patient before they had the device implanted. A checklist would be required that both the doctor and patient must sign off on that would discuss the benefits and risks of the Essure devices.
Reports of Adverse Events
The FDA announced that it has received nearly 10,000 adverse event reports related to the device. The injury reports come from doctors as well as patients and all claim that Essure has caused serious side effects with at least two deaths that have been confirmed to be related.
Essure Production Halted and Settlement Reached
The manufacturer, Bayer, announced that it would stop selling Essure in the US in 2018. It had already stopped selling Essure in other countries. Thousands of lawsuits filed prior to and after this date were formed into a class-action lawsuit.
In 2020, Bayer AG finally agreed to settle with the litigants in a class-action lawsuit for a $1.6 billion Essure settlement. The money from the Essure lawsuit was intended to be paid out to individuals as well as those who joined as a class.
Seek Legal Advice
If you have been the victim of medical malpractice, defective medical devices, dangerous drugs, or other issues in receiving medical care, you can seek compensation for your injuries with an experienced law firm. A personal injury law firm can help you obtain settlement agreements and resolve claims without going to court. If it becomes necessary to go to court, an experienced attorney will fight on your behalf.
Getting Temporary Financial Help
Claimants waiting on a payout from pending litigation can benefit from pre-settlement funding to help them pay bills until their case is settled. They don’t have to worry about repaying the money because it will come out of the settlement once it is dispersed. Lawsuits can take months or even years to be settled, which can place a severe hardship on the litigants.
Pre-settlement funding is a financial product that is provided to plaintiffs with a personal injury claim in certain circumstances. Pre-settlement funding is sometimes referred to as consumer legal funding and, depending on your state, is either provided as a loan or via a purchase agreement under which the plaintiff sells a portion of their potential legal award. It may also be called a personal injury cash advance, but this is only accurate in those states where pre-settlement funding is provided as a loan. You can apply for one as long as your case is pending and use the money to cover daily expenses or costs related to your injuries.