Essure is intended to be a permanent birth control system. It’s a flexible tube inserted through the vagina and cervix and placed in the uterus. The fiber coils of the device are placed in the fallopian tubes, blocking the release of eggs and preventing sperm from reaching the eggs by causing scar tissue to form around the coils. Once in place, the system takes at least three months to become effective, but is ultimately intended to offer permanent prevention of pregnancy.
Essure has created cause for concern since it was first approved and in 2016, the FDA issued its most stringent warning for the device, requiring its manufacturer to put a black box warning on its label. The warning is intended to alert doctors and patients to potential risks associated with the device.
In response to the more than 5000 adverse event reports the FDA has received concerning Essure, the agency convened a panel of experts to review data. They ultimately recommended there is not enough information available to consider Essure a safe device and they recommended that the black box warning be added to packaging.
In September 2017, Bayer announced it would take the device off the market in all areas it is sold outside of the United States. According to the company, it’s doing this because the device is unpopular and not because of any potential side effects linked to the device.
The year before, the FDA ordered Bayer to conduct post-market surveillance and gather additional information about Essure in an effort to better understand the complications that have been reported to the agency by users.
Side Effects and Complications Linked to Essure
Despite the FDA calling Essure an “appropriate treatment for the majority of women seeking permanent birth control,” implantation of the device comes with risks, including:
- Unbalanced tubal blockage (scar tissue forms on only one side)
- Unintended pregnancy
- Pelvic pain
- Perforation of the uterus or fallopian tubes due to device migration
- Need for follow-up surgery to have the device removed
These are in addition to the common side effects that occur after Essure implantation, including mild to moderate pain, vaginal bleeding, cramping, nausea and vomiting, lightheadedness, and pelvic or back discomfort.
Essure Birth Control Lawsuit
Numerous lawsuits have been filed against Bayer, maker of Essure, after women have experienced serious complications. In 2016, a California court allowed a dozen Essure lawsuits to proceed alleging the device seriously injured users. Bayer asked the case to be thrown out, but the judge ruled the company could be held liable for the problems caused by its device.
There are more than 200 additional lawsuits concerning Essure in the California court system and more throughout the country in federal court.
Plaintiffs in the cases have a variety of allegations, including fraud, negligent misrepresentation, and negligence. They claim Bayer failed to properly test Essure and to monitor it once it was on the market. Claims also state that doctors were not properly educated by the company to be able to provide patients with the appropriate information to allow them to make a decision about the device.
Patients or family members of those who have been injured by Essure may be eligible for compensation for their injuries or loss through an Essure lawsuit. Each case is unique and should be evaluated separately by a legal expert.