Essure is a permanent birth control device designed to prevent pregnancy without the need for surgery. Essure is the only type of birth control device on the market designed to permanently prevent pregnancy without surgery.
This makes it an attractive option for many women because they can get back to their normal daily activities almost immediately.
Essure is made of two small, metal coils that are inserted into a woman’s fallopian tubes. The Essure coils cause scar tissue to form in the fallopian tubes, which closes the tubes and prevents pregnancy. The Essure procedure is performed in a doctor’s office in as little as 30 minutes. During the procedure, doctors use a small tube to place the coils into the fallopian tube through the vagina and cervix.
Essure is marketed as a safe alternative to tubal ligation—the only other form of permanent birth control available to women. Essure manufacturer Bayer claims the birth control implant is over 99 percent effective in preventing pregnancy, yet thousands of women are claiming otherwise. Women have reported adverse events including unplanned pregnancies, abdominal pain, allergic reactions, and other serious side effects. Many of these women are now filing lawsuits against Bayer to hold the company accountable for their pain and suffering.
Modern birth control has given women the freedom to start a family on their terms, allowing them to choose when they get pregnant and when they don’t. Advances in medical technology have opened up the number of birth control options for women, meaning they can find the type of birth control that is right for them. This freedom of choice rests on the idea that women are given all the facts they need to make informed decisions about their ideal birth control. But the number of lawsuits mounting against healthcare giant Bayer and its birth control Essure shows that women—and even health care providers—are not receiving the full information they need to choose what’s right for them.
Women must use another form of birth control, such as condoms after the Essure procedure is complete because it can take anywhere from three to six months for scar tissue to form and completely close the fallopian tubes. About three months after the procedure, women must return to their doctor for an Essure confirmation test to make sure their fallopian tubes are closed. If the tubes are not entirely closed, women are at risk for pregnancy because sperm can still enter the tubes and fertilize an egg.
Women who rely on Essure for birth control are saying the device caused them severe side effects and other problems. Some of these side effects include cramping, persistent pain in the pelvic cavity, nausea and vomiting, dizziness, irregular periods and bleeding, bloating, constant feelings of discomfort, itchy skin, and more.
Essure has also been associated with more severe side effects, including device migration, perforation of the uterus and the fallopian tubes by the device, severe allergic reactions, unplanned pregnancies, dangerous ectopic pregnancies, and even death.
Tens of thousands of adverse event reports have been submitted to the U.S. Food and Drug Administration regarding these side effects. Both women who use Essure and doctors who see women for their symptoms have sent these reports. Because Essure is meant to be permanent, there is no way to remove the device without surgery. Many women have opted to have full or partial hysterectomies to get the Essure implant out and relieve their symptoms.
The side effects of Essure have caused so many problems in so many women the FDA added a black box warning to the device’s label. In February 2016, the FDA announced it intended to add the notice and by the following November, the agency had approved the new label. Boxed warnings are the FDA’s strongest warning short of a recall.
In addition to the black box warning, the FDA also required Bayer to include a patient-doctor decision checklist that women and their doctors must read and sign before continuing with the Essure procedure. The checklist provides essential safety information regarding the potential risks of Essure, including possible side effects.
In spite of these labeling changes, the FDA announced in April 2018 it would be restricting sales of Essure in the United States. The regulatory agency said the restrictions were necessary because some women were still not receiving adequate information about the risks of the device before getting Essure. The FDA’s decision puts further restrictions on who can get the device, limiting sales of Essure to only those health care providers who read and sign the patient-doctor discussion checklist with their patients.
Sales of Essure were already down about 70 percent in the U.S. before the FDA’s announcement. With restrictions in place, those sales could drop even further.
Women injured by the permanent birth control Essure are filing lawsuits against its manufacturer, Bayer. The first Essure lawsuits were filed in late 2015 and early 2016, but it has been a difficult road because of one major obstacle: federal preemption.
Essure received federal preemption when the FDA approved it through its Premarket Approval Process. Essure and other class III medical devices are subject to more rigorous premarket clinical studies, which grants them federal preemption and shields them from product liability lawsuits.
Attorneys are working to bring Essure claims to court despite these obstacles and have made significant progress in state courts, where judges have allowed Essure lawsuits to proceed. Women harmed by Essure deserve to see their day in court. Filing an Essure claim can bring you one step closer to yours.
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