Cincinnati Product Liability Lawyer reviewing defective Birth Control Devices and reports of sales of Essure Discontinued
Bayer AG announced it will discontinue the sale of its birth control product Essure in the United States, saying that a decline in sales of the device makes the product unsustainable. In September 2017, Bayer discontinued the sale of Essure in all countries outside the United States. Despite the company facing about 16,000 U.S. lawsuits over Essure, Bayer says the product is not discontinued due to safety concerns.
The U.S. Food and Drug Administration (FDA) has been alerted of the decision and patients implanted with the device will have to monitor their health as the product is phased out. Doctors will be able to perform Essure implant procedures until the end of next year.
Joe Lyon is a Cincinnati product liability attorney and Ohio Essure Device Lawyer investigating injuries related to the birth control device nationwide.
The Essure implant, consisting of two small coils made of a nickel alloy, is placed into the fallopian tubes, and is designed to create an inflammatory response that causes scar tissue to form, blocking the tubes.
In 2016, the FDA ordered a “black box warning” on the product package that warned of injury risk, including that the implant could travel into the abdomen and pelvic cavity. Sales of the device in the United States had declined by about 70 percent since the agency ordered Bayer to place the boxed warning and patient decision checklist on labeling. The FDA put its strongest safety warning label on the device after thousands of complaints and asked Bayer to conduct a post-market study. The FDA received nearly 12,000 adverse event reports in 2017 related to Essure.
Bayer has sold about one million Essure devices worldwide since the product was put to market in 2002—the majority of sales in the United States. The FDA has issued several warnings, saying some women were not being properly informed of the risks associated with Essure.
Women have claimed Essure, which is implanted in a woman’s fallopian tubes, could pierce the tubes, and that metal parts from the device could migrate to other parts of the body, causing pain, injuries and severe bleeding. Victims also claimed the device failed to prevent unwanted pregnancies and depression. Bayer has been accused in lawsuits of knowing the risks associated with Essure and failing to warn distributors, doctors, safety regulators, and patients.
If you or a loved one suffered an injury due to a defective Essure implant, and have questions about the legal remedies available to improve quality of life and medical care in Ohio, contact The Lyon Firm (800) 513-2403. You will speak directly with Mr. Lyon, and he will help you answer critical questions regarding Essure discontinued devices.