Women looking to permanently prevent pregnancy typically have no option but to undergo surgery. For these women, the invention of the Essure implant, which offered a high rate of success without surgery, must have seemed like a perfect solution.
However, many patients soon discovered the device carried more complications than benefits, and may even have caused some to suffer an early death.
What is Essure?
Bayer developed Essure, and the U.S. Food and Drug Administration (FDA) approved its use in the United States in 2002. Marketed as a surgery-free and hormone-free form of irreversible birth control for women who have chosen not to have any future children. The Essure device is a small, flexible medical apparatus implanted into a patient’s fallopian tubes.
Over the course of three months, the body covers the implant with scar tissue, blocking the passage between the ovaries and the uterus and preventing eggs from becoming fertilized during intercourse.
Essure was designed to be an easier alternative to permanent female birth control, which typically required a surgery called a tubal ligation. Tubal ligation, commonly called “having your tubes tied,” is an invasive and complicated surgical procedure that requires anesthesia, prolonged recovery, and regular hospital visits during healing.
In contrast, Essure implantation can be performed in a doctor’s office and doesn't require a surgeon or a surgical team. A trained medical professional feeds a catheter past the uterus into the fallopian tube, dropping the device in place. The procedure takes only a few minutes and allows the patient to recover in just a few days with minimal pain.
Why Are People Filing Lawsuits About Essure?
Since 2002, the FDA has received more than 15,000 reports of adverse events associated with the Essure device—at least 30 of which have been fatal. Patients have even filed product liability lawsuits for the serious complications related to the device. Women are seeking legal remedies for:
- Severe injuries. Women report a wide range of complications from the Essure device, including chronic and severe back or pelvic pain; heavy and prolonged menstrual periods, unintended pregnancies, neurological damage, allergic reactions to metals in the device, and miscarriages. Many patients suffered injuries as the coils migrated from their placement or became embedded in other tissues, causing organ perforation or spontaneous ejection of the device.
- Chronic pain. Some women reported severe pain almost immediately upon receiving the device, and suffered additional painful adverse reactions that included migraines, joint pain, and overwhelming fatigue that prevented them from earning a living.
- Misleading marketing. Some women are claiming the makers of Essure focused on the benefits of the device while significantly downplaying the risk of danger to patients. The device, which was supposed to be minimally painful and maintenance-free, proved to be exactly the opposite for women who needed to undergo emergency hysterectomies or suffered chronic and debilitating pain.
- Improper warnings. The FDA approved Essure through an expedited review process, allowing it to be released onto the market without extensive testing. After receiving reports of injury and device migration, the FDA ruled the device should carry a “black box” warning on its label—the highest level of FDA warning of potential injury or death. The agency also issued a statement requiring manufacturer Bayer to perform additional post-market safety research.
The FDA has taken action to make sure the manufacturers of Essure know exactly how harmful the implant is, but the device is still implanted in patients every day.
Women who received the Essure device may have no recourse but to file an injury claim against Bayer, the manufacturer, to force the company to assume responsibility for creating a dangerous product. Our attorneys can listen to the facts of your case and determine if you're eligible to recover medical costs, lost wages, pain and suffering, and other damages. Simply fill out the contact form on this page today to set up your consultation with our Florida medical device injury attorneys.