Product News and Recalls

After Essure Case is Dismissed, Appeals Court Says Not So Fast

appeals court overturns essure lawsuit dismissalThe device caused such an outrage in countries around the world that Bayer removed it from the market. However, despite thousands of reports of injury and tens of thousands of women lobbying to have it pulled from US shelves, Essure is still available in the United States.

Injuries continue to mount as a result. In the meantime, a plaintiff in a previous Essure injury case; Jessica Williams of Boonville, Missouri, will have another chance to make her voice heard as an appeals court recently overturned the previous dismissal of her Essure lawsuit.

Williams, age 33, had an Essure device implanted in her fallopian tubes in 2013. Unlike an IUD, Essure is designed to bring about permanent sterilization in the patient. The coil-shaped device stimulates the production of scar tissue around the implantation site. This scar tissue eventually causes a blockage of the fallopian tubes and leads to permanent sterilization.

Like so many others, Williams began experiencing severe pain after her procedure and eventually opted to have the Essure removed. An x-ray conducted during the removal showed that a worst-case scenario had unfolded: Williams’ Essure had broken apart and pieces of the device had perforated her uterus. She would eventually have a hysterectomy as the only viable solution for dealing with the residual pain.

As unfortunate as Ms. Williams’ story may be, it is far from unique to those who have been watching the consequences of Essure use in the US. Thousands of Essure injuries have been reported to the United States Food and Drug Administration, up to and including perforation of organs and even death. Injury reports began coming into the FDA shortly after Essure was released to the public in 2002 and have continued to flood the agency since.

And, while populations around the world appear to have deemed the device too dangerous to use, the most severe reaction on the part of the US government has been the addition of a black box warning. No recalls have been ordered on Essure to date and Bayer is, for all intents and purposes, responsible for its own tracking and reporting of Essure-related safety issues.