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Bayer Essure Warning May Have Come Too Late

Thousands of women are suing Bayer Pharmaceuticals claiming that the new warnings on their Essure birth control coil are for them, too little, too late

Wednesday, December 27, 2017 - Bayer Pharmaceuticals markets the Essure birth control coil as, "A minimally invasive procedure, Essure placement requires no cutting, leaves no visible scars, and can be performed in your doctor's office," yet issues the following warning: "WARNING: Some patients implanted with the Essure System for Permanent Birth Control have experienced and/or reported adverse events, including perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions. If the device needs to be removed to address such an adverse event, a surgical procedure will be required." Bayer also warns women to be sure that they are sure that they are finished with having children as the device is permanent and irreversible birth control. The company states to make sure to use other birth control methods during the first three months after being implanted with Essure as it takes time for the device to take effect, i.e., scar tissue to build up. Essure is a titanium coil that is inserted into each fallopian tube, creating inflammation which the body reacts to naturally by creating scar tissue. The scar tissue is designed to encase the device in place and to form a barrier preventing a man's sperm from reaching a woman's eggs. Essure has been implanted successfully in hundreds of thousands of women, yet thousands have reported experiencing complications such as infections that cause chronic pain, allergic and immune system reactions, irregular and excessive bleeding. In some women, the device has not affixed to the fallopian tubes and has migrated to and punctured completely through the uterus. Doctors attempting to remove the device have found the coil as far away from the fallopian tubes as in the woman's pelvic cavity and abdomen. And they may be the lucky ones. Women wishing to have the device removed very often require a complete hysterectomy as the device has become embedded in the fallopian wall and unremovable.

Critics of the device, normally women who are experiencing the adverse effects from the coil, say that inadequate pre-market testing by the Food and Drug Administration has led to women being ill-advised to its adverse side effects beforehand and that they were denied their right to make an informed decision. Since its approval in 2002 over a decade passed before Bayer was forced to include a "Black Box" warning on packages of the product. A black box warning is the most severe and is reserved by the FDA for drugs and medical devices that have the potential to cause serious bodily injury or even death.

According to Bayer's annual report, expenses related to Essure birth control lawsuits have cost the company close to $500,000 in 2016. That number is certain to increase in the years to come as over 3700 women have filed suit against the German pharmaceutical company alleging a multitude of sins including failing to warn women of the array of serious, painful and potentially life-altering complication that the device causes in women.

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Onder Law is a St. Louis personal injury law firm handling serious injury and death claims across the country. Its mission is the pursuit of justice, no matter how complex the case or strenuous the effort. The Onder Law Firm has represented clients throughout the United States in pharmaceutical and medical device litigation such as Pradaxa, Lexapro and Yasmin/Yaz, where the firm's attorneys held significant leadership roles in the litigation, as well as Actos, DePuy, Risperdal and others, and other law firms throughout the nation often seek its experience and expertise on complex litigation.