Essure Banned Outside U.S.
Bayer says global market withdrawal unrelated to Essure problems
Tuesday, October 31, 2017 - Bayer HealthCare of Berlin recently announced a global withdrawal of the medical device Essure, in all markets except the United States. The announcement comes after several governments have issued stringent Essure warnings and bans, yet the company insists its decision is not equivalent to an Essure recall. Thousands of American women have lodged complaints about Essure problems to the FDA and have filed Essure lawsuits against Bayer, yet the device remains available in the United States.
Essure is a medical device implanted in women to achieve permanent sterilization. To date, the FDA has received thousands of adverse event complaints from American women who assert they were not aware of the potential for serious side effects from the device or who have become pregnant. While Essure is currently the subject of an FDA investigation, the controversial device is still available in the U.S. and the agency states it believes the benefits of the device outweigh the risk of Essure problems. A Black Box warning, added in 2016, began alerting patients to the potential for severe side effects 14 years after the product was first approved for use in the United States.
Essure Warnings Issued by Brazil, Canada, Australia and EU
In February of 2017, the Brazilian health service took the bold step of issue an Essure recall and ban. Brazilian law permits the government to take such action when the safety of a medical device is called into question. Essure defects that put patients at risk constitute such an event; reports of Essure side effects including persistent abdominal and pelvic pain, device perforation of internal organs, uterine bleeding, and allergic reactions prompted the Essure recall. The overall effectiveness of the device at preventing pregnancy has also been called into question. Women suffering from one or more Essure side effects have in some cases been required to undergo one or more gynecologic surgery to remove the device.
The Australian health service, Australasian Medical and Science Limited, followed suit with an Essure recall and warning in August of 2017. This agency warned that patients had not been made aware of the potential for serious Essure side effects and the potential need for surgery to resolve resulting medical conditions. That same month, the EU retracted Bayer‘s license to market Essure in Europe during August, September and October.
Back in May of 2016, Health Canada was the first government to take a stance to protect its citizens with an Essure warning, adding a Black Box label to the medical device. This new label included a checklist for women considering Essure as a means of sterilization, and served as an example for the Black Box warning eventually adopted by the FDA in November of 2016.
Bayer Announces Essure Ban
In October of 2017, Bayer HealthCare announced Essure would no longer be marketed in countries outside the United States. In its announcement, the company insisted the decision was based on cost/benefit analysis rather than the device‘s safety profile or any new Essure side effects information. Indeed, as countries around the globe have issued Essure bans and warnings, sales would undoubtedly flag in markets worldwide. Only in the United States, where the device is ‘under surveillance‘ but still widely available, will Bayer continue to market Essure.
Women and the family members of women who have experienced serious Essure side effects including pain, perforation, the need for gynecologic removal surgery, abnormal bleeding, and hypersensitivity reactions may be eligible for compensation through filing Essure lawsuits. Our attorneys are offering no-cost, no-obligation Essure lawsuit case review to anyone who matches this description. Complete the contact form on this site to access your free case review with an experienced Essure attorney today.
Information Provided by The Onder Law Firm
The Onder Law Firm 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. Onder, Shelton, O‘Leary & Peterson 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. The firm has represented thousands of persons in these and other products liability litigation, including DePuy hip replacement systems, which settled for $2.5 billion and Pradaxa internal bleeding, which settled for $650 million. The Onder Law Firm has won more than $300 million in four talcum powder ovarian cancer lawsuits in St. Louis. Law firms throughout the nation often seek its experience and expertise on complex litigation.
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