Thirty-two women recently filed a lawsuit against Bayer AG in St. Louis, Missouri, claiming the Essure birth control device caused serious and permanent injuries. The FDA-approved Essure device implants two coiled springs in the fallopian tubes to cause scar tissue to build up around the springs. This process essentially closes off the tubes and prevents pregnancy. The first lawsuit against Bayer AG was filed in 2014. In that Essure lawsuit, the coils had been improperly implanted with three coils instead of two which caused them to migrate out of the fallopian tubes and lead to serious health problems.
The most recent suit claims that not only did the women experience injuries, but that Bayer AG and the original manufacturer of the device, Conceptus Inc., hid the risks from consumers. It also claims clinical trial results on the Essure device were altered to make them appear more favorable. Bayer AG hid research which suggested Essure could be a defective and dangerous medical device. Approximately 750,000 devices have been implanted in what is called a quick, nonsurgical procedure.
The FDA has recently asked Bayer for more data on the device. They may require the most restrictive type of warning possible on Essure's label to ensure potential consumers reliably receive and understand the risks associated with the device. According to the FDA, some patients have reported not only pain, but depression, weight gain, fatigue, allergic reactions and hypersensitivity.
If you or someone you know is having complications you think may be related to an Essure device, please contact our pharmaceutical injury lawyer in Raleigh today using the form on this page or call (919) 800-0919 to schedule a FREE consultation. Wilson Law, P.A. serves clients throughout North Carolina including Raleigh, Durham and Chapel Hill.