Thousands of women throughout the United States have suffered life-altering complications through the use of a permanent contraceptive device called Essure®, manufactured by Bayer AG. These reports of injury have included severe health complications, including chronic pain and bleeding as well as organ perforation requiring surgical removal.
In August 2020, Attorney Erin Copeland of Fibich, Leebron, Copeland & Briggs helped negotiate a settlement with Bayer for $1.6 billion to resolve the majority of Essure® cases in the U.S., which totaled about 30,000. After many years of advocating for women who were harmed by this dangerous product, Attorney Copeland is proud to see this lawsuit come to a successful close. Read more on our blog: “Erin Copeland Helps Negotiate Essure® Settlement for $1.6 Billion“
The device, originally marketed as a safe and effective non-surgical alternative to tubal ligation, first received clearance from the FDA in 2002. Since then, however, there has been enormous cause for concern that the product may not be as safe as previously thought. The FDA is currently weighing the risks and benefits of this defective medical device to further investigate the potential to harm users.
More than 5,000 adverse side effects have been reported to the FDA in connection with the device. While the exact cause of the device’s failure has yet to be determined, it has been conjectured that a latent manufacturing issue could be responsible for a large number of reported problems. Another theory has suggested that nickel and other metals that the device is made from could potentially cause an allergic reaction leading to the onset of symptoms.
Bayer and the FDA should never have allowed a dangerous product into the market without fully understanding and disclosing the risk of serious side effects. This failure to warn the public is not only deceptive, but it has proven unacceptably dangerous.
In 2015 the FDA issued a black box warning for Essure® regarding the risk of organ perforation; in 2018 doctors were required to receive written confirmation from patients that they accept the risk involved with the device.
In 2018, Bayer removed Essure® from the U.S. market due to declining sales after having already pulled it from the market in all other countries years prior. Even after arriving at the $1.6 million settlement agreement, Bayer has denied liability for the injuries connected with Essure®. Notwithstanding, the result of this lawsuit is a significant victory for both the plaintiffs and legal team involved.
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