Update: On July 20th, 2018, Bayer announced it will stop selling Essure Birth Control Implants. “This decision is based on a decline in U.S. sales of Essure in recent years and the conclusion that the Essure business is no longer sustainable,” Bayer said in a statement.
Bayer had already discontinued marketing and sales of Essure outside of the United States in September 2017.
Essure is made of two small coils that are placed into the fallopian tubes and is intended to cause inflammation and scar tissue that forms and blocks the tubes, preventing pregnancy.
Read more about this decision in our article about the recent decision.
With the emergence of modern birth control, women can choose when they want to start a family and when they do not. As medical technology advanced over the years, more birth control options were made available, giving women the chance to choose which birth control method was right for them.
Just because there are more options, doesn’t mean women have all the necessary information about each technique to make an informed decision. The number of lawsuits piling up against Bayer, the manufacturer of the birth control Essure, highlights the fact that women, and in some cases their health care providers, are not getting the necessary information they need to choose what’s best for them.
The maker of Essure device claims its effective and safe with an easy insertion procedure
Essure is a permanent, non-surgical birth control device designed to prevent pregnancy in women. It is the only one of its kind on the market intended to avoid pregnancy without a surgical procedure permanently. For this reason, Essure is an attractive option for many women, as they can return to their regular activities almost immediately after insertion.
Essure consists of two metal coils placed inside the fallopian tubes. The Essure coils are designed to cause scar tissue, thereby closing the tubes and preventing pregnancy. The Essure procedure, conducted in a doctor’s office, usually takes less than an hour. During the procedure, doctors use a small tube to insert the coils into the fallopian tubes through the vagina and cervix.
After the procedure, women still need to use another form of birth control because it can take months for the scar tissue to form and close the fallopian tubes completely. Typically, about three months after the initial procedure, women must go back to their doctor to take the Essure confirmation test, during which doctors use dye to see whether or not the tubes are completely closed. If they are not, women may be at risk for pregnancy because sperm is still able to enter the tubes and fertilize an egg.
Bayer markets Essure as a safe alternative to tubal ligation, which is the only other option women have for permanent birth control and requires surgery. Bayer claims its Essure implant is over 99 percent effective, but women who use it have argued otherwise. There are reports of unintended pregnancies in women using Essure, along with thousands of other complaints against the device. Women have reported adverse events including abdominal pain, severe cramping, allergic reactions, and more severe side effects. Now, women are choosing to file lawsuits against Bayer to hold the company accountable for the costs they’ve endured.
Essure Birth Control causes problems in thousands of women
Thousands of complaints have been reported to the U.S. Food and Drug Administration by women who rely on Essure for birth control and who suffered from pain and other side effects. Some of these side effects include cramping, bloating, nausea and vomiting, persistent pain in the pelvic cavity, dizziness, bleeding and irregular periods, constant discomfort, skin itching, and much more.
The device has even more severe side effects, including migration of the device, perforation of the uterus and or fallopian tubes by the device, device breakage, severe allergic reactions, unintended pregnancies and ectopic pregnancies, and even death.
The FDA has received tens of thousands of adverse event reports documenting these side effects. Since Essure is a permanent birth control device, many women who suffer from side effects choose to have hysterectomies to remove the device.
Because of the number of side effects reported, the FDA announced in February 2016 it would be adding a black box warning to the device’s label. In November 2016, the FDA approved the warning and every new Essure device sold now come with the boxed warning. Black box warnings are the strongest warnings given by the FDA, short of removing the device from the market. For many women, the warning wasn’t enough. They are fighting alongside their advocates to get Essure off the market.
On top of the boxed warning, Bayer was also required to include a patient-doctor discussion checklist to be signed by women and their doctors before getting an Essure device. The checklist contains important safety information about Essure’s potential risks and possible side effects.
Despite these changes, the FDA continues to take action regarding Essure. In April 2018, the agency announced it would begin restricting sales of Essure in the United States because women were still not getting enough information about the device’s risks before they went through with the procedure. The FDA’s latest action limits the sale of Essure to only those health care providers who read and sign the patient-doctor discussion checklist with their patients.
Even before the FDA’s announcement, sales of Essure were down about 70 percent in the U.S. Those sales could drop even further now that the restrictions are in effect.
Essure lawsuits mount against Bayer
Bayer is facing an increasing number of lawsuits involving its permanent birth control Essure. Women who were harmed by the device first began filing lawsuits in late 2015 and early 2016. The number of lawsuits continues to rise as more and more women come forward. There is one major obstacle that lawyers and attorneys have had to fight to overcome when it comes to filing an Essure lawsuit: federal preemption.
When the FDA approved Essure in the early 2000s, it passed through the agency’s Premarket Approval Process. This “fast-track” approval process meant it was subject to more rigorous clinical testing before it could go to market but the validity of those studies remain in question.
Through the PMA process, Essure was granted federal preemption which effectively shields it from product liability lawsuits. Attorneys across the country have been fighting to overcome those obstacles and bring Essure claims to court. Since 2016, significant progress made in state courts and judges, have allowed those lawsuits to proceed. Women harmed by Essure deserve to see their cases play out in court. Filing an Essure lawsuit can help bring you one step closer to seeing your day in court.