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Essure Problems Will Continue For Decades to Come

Essure has been touted as permanent birth control but so is Bayer's liability

Saturday, December 22, 2018 - With millions of Essure devices implanted in women, it could be said that no matter what punitive actions the government takes against Bayer, the damage has been done. There is nothing that an Essure doctor can do to alleviate their patient's suffering other than to attempt to locate the device or the pieces of it that have wandered within a woman's reproductive system and to remove what can be removed. Essure is viewed by medical experts as a ticking time bomb that could fail millions of women in the years to come.

In spite of Bayer halting Essure sales effective December 31, 2018, The US Food and Drug Administration (FDA) has vowed to continue to monitor the situation with post-market studies. For millions of women, the FDA's sudden Essure concerns are too little and come too late. Along those lines, FDA commissioner Scott Gotlieb has issued a statement in writing regarding Essure going forward and stresses that just because Bayer has stopped selling the device they are still liable for completing post-market tests and monitoring the ongoing risks of the device. Gotlieb pledges the FDA's continued safety oversight of Essure. Gotlieb views the monitoring of the safety of the device as an extension of the FDA's initiative that placed restrictions on sales of Essure leading to its being pulled from the market. Essure birth control lawsuit attorneys provides information such as questions and answers to most commonly asked questions on their webstie.

Back in Apri of 2018, the FDA required physicians that recommend Essure to women seeking birth control to complete a questionnaire that listed many of the known risks of Essure. The patient brochure warned of patients experiencing acute and persistent pelvic pain. Also that Essure is known to cause conditions "unrelated gynecological (for example endometriosis, adenomyosis) or nongynecological (for example: irritable bowel syndrome, interstitial cystitis) conditions may result in pain."

The patient brochure went on to state that Essure can migrate to other parts of the body and if that happens will fail to prevent pregnancy and that surgery would be necessary to remove the device. Another adverse side effect included in the patient brochure is the fact that many women have metal allergies or hypersensitivity that can be activated by Essure. "Patients with known hypersensitivity to polyester fibers, nickel, titanium, stainless steel (iron, chromium nickel), platinum, silver-tin and/or any of the components of the Essure system may experience an allergic reaction to the insert."

The results of the FDA's restriction on Essure's sales resulted in sales falling by 70% according to Bayer and was the cause of the company's discontinuation of selling the device.

The FDA is to be commended for getting out ahead of the problems that are sure to surface in 2019. Even though Bayer has pledged to stop selling the device next year, Essure doctors will have at least one year's inventory of the device on hand and most likely will continue to recommend the device to their patients. The FDA requires Essure patients in 2019 and beyond to continue to be registered with the FDA that they have received and understand the patient brochure.

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OnderLaw, LLC 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. OnderLaw 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.