Falling on Deaf Ears
Bayer is arguing it should be shielded from any liability since it received pre-market approval from the U.S. Food and Drug Administration (FDA). However, the FDA granted this approval based on the company’s claim that it had followed the proper research protocols to ensure the device was safe. Plaintiffs, however, are alleging that the research did not adhere to the proper protocols. As a result, they say, Bayer should be forced to face legal action for injuries linked to Essure.
The court ruling means that Bayer may not only be liable for injuries alleged in current lawsuits against the company but also potential future lawsuits. So far, approximately 200 lawsuits have been filed in California alone.
Problems Associated with Essure
The Essure device is a small coil that is inserted into the fallopian tubes in order to prevent eggs from being fertilized. It is designed to stimulate the development of scar tissue to block each tube. If you’ve ever heard someone use the term “getting your tubes tied” as a form of permanent birth control, that is what Essure is supposed to do.
Many women, however, have suffered severe complications and serious injury after having the Essure implanted. These include debilitating pain, organ perforation due to migration of the device, and more. About 5,000 adverse events have been reported to the FDA — the actual number of women suffering complications is more than likely much, much larger.