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Study Shows Essure Makers Used Flawed Data to Gain FDA Approval
Bayer, the maker of the Essure contraceptive device, is claiming that it cannot be sued for Essure-related complications because the device gained U.S. Food and Drug Administration (FDA) approval. A recent study from Northwestern University, however, could seriously damage that argument.
Problems Associated With Essure
Many women who have used Essure have reported severe complications. These include migration of the device, extreme pain during intercourse, perforation of the fallopian tubes, expelled devices, and more. Some women have endured pain for several years before their doctors finally found that Essure was likely to blame. In many cases, women have had to undergo hysterectomies in order to finally find relief.
For many women suffering from these horrific complications, now is the time to file a lawsuit for Essure problems.
A Potential Game Changer?
Northwestern researchers looked at how the FDA has regulated women’s medical devices from 2000-2015. According to the authors of the study, the FDA’s current approval process is not rigorous enough. They pointed to Essure as an example. The researchers say that Essure gained approval in 2002 based not only on questionable evidence, but also on an insufficient amount of post-market follow-up to ensure it was safe.
Plaintiffs in many Essure cases are alleging that Conceptus (the original manufacturer of Essure that Bayer later purchased for about $1.1 billion in 2013) fraudulently withheld information from the FDA during the pre-market approval process. They claim that because of this fraud, Bayer should not be protected from legal action.