Essure birth control users have continue to file lawsuits against the device’s manufacturer, Bayer, and recently, a California judge ruled several cases will be allowed to advance, despite claims of immunity from Bayer. The company believes it should be immune to the lawsuits because FDA approval came in 2002, prior to Bayer’s acquisition of Conceptus and the right to manufacture the device.
Bayer further claimed the statute of limitations had expired regarding problems for Essure users, and that California was not the proper location for filing the lawsuits because not all of the plaintiffs were from the state.
All three claims were rejected by the court, opening the door to what could result in thousands of lawsuits against the company, at least 200 of which are expected to be filed in California.
Mounting Complaints Related to Essure
In recent months, many Essure users and their doctors have come forward with complaints to the FDA regarding their birth control devices. They claim the implants have created a number of health issues, ranging in severity from bloating and pain to the need for surgery to retrieve devices that have migrated to other parts of their bodies.
Since Bayer added updates to its product label regarding issues with abdominal pain and device migration, an additional 1500-plus complaints were received by the FDA. Some believe women did not realize Essure was related to their health issues and assumed the device was safe and effective until the warnings were issued. There are many in the medical industry who believe this is just a small fraction of those injured by Essure – possibly as little as 10 percent – and there are actually far more women affected than has been reported so far.
Bayer and Previous Manufacturer Conceptus Likely Knew of Essure Risks
Investigations have now revealed that Conceptus and Bayer likely knew of the issues with Essure, but failed to warn doctors and users of the device. As complaints about Essure continued to roll in, the FDA discovered clinical trials performed by Conceptus had shown issues with pain and device migration. Some additional issues with the device, such as weight gain and depression, uterine perforation, migraines, and ectopic pregnancy were not revealed during clinical trials, but have since arisen for users.
The FDA began investigating the device in 2014 and continues to monitor complaints about the device. It issued an order to Bayer in February 2016 to begin clinical safety studies on the device and required a black box warning regarding the safety of the device be placed on Essure boxes. Despite the issues and severest warning, as of August 2016, the FDA has allowed Essure to remain on the market, claiming the benefits outweigh the risks of using the device.
At the moment, dozens of lawsuits have been filed against Bayer alleging the manufacturer failed to warn the public and doctors of the risks associated with the Essure device and thousands more are expected. Many of the plaintiffs involved in the lawsuits experienced medical issues severe enough to warrant follow-up procedures to remove the device.
If you or a loved one experienced complications after using Essure birth control, please contact us to learn more about what you can do.