Essure Sterilization Lawsuit Filed By 32 Women, After FDA Requires Black Box Warning About Risk of Problems
Less than a month after the FDA required a new “black box” warning about the risk of problems with Essure sterilization procedures, a group of 32 women have filed a product liability lawsuit against Bayer claiming that they suffered permanent and debilitating injuries after receiving the birth control implant.
The complaint was filed earlier this month in St. Louis Circuit Court, indicating that Bayer knew or should have known about the risks associated with Essure sterilization, yet failed to adequately warn women and the medical community for years.
Essure is a permanent sterilization procedure, which involves the implant of bendable coils into the fallopian tubes, which causes scar tissue to form around the coils and block the tubes. However, thousands of women have reported suffering complications following Essure procedures, including migration of the coils, allergic reactions, infections and other problems.
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The case joins a growing number of Essure sterilization lawsuits filed in recent months, each involving similar claims that Bayer intentionally hid evidence of problems with their device. In many cases, women have required a total hysterectomy to remove Essure coils after experiencing painful and life-changing problems.
Amid mounting reports of problems experienced by women who underwent an Essure procedure for sterilization, the FDA held advisory panel meetings last year, to review the safety of the device and evaluate whether an Essure recall should be issued.
After considering recommendations from the panel of outside experts, the FDA announced late last month that the product will be allowed to remain on the market, but Bayer was required to place much stronger Essure warnings in a prominent black box on the label, to make sure doctors and women are informed of the potential risks.
Bayer has also been ordered to conduct additional studies to better understand the safety of the Essure implant, raising questions about why the manufacturer failed to take these steps years ago after receiving complaints.
An estimated 750,000 women worldwide have undergone Essure sterilization procedures since the device was introduced in 2002. Bayer purchased the Essure product from the original developer, Conceptus, for about $1.1 billion in 2013.
As Essure injury lawyers continue to review and file potential cases for women nationwide, it is ultimately expected that Bayer could face several thousand lawsuits in courts throughout the U.S.
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