Troubles for Bayer
Troubles are mounting for Bayer Pharmaceutical’s permanent female birth-control device, Essure. Amid allegations that Bayer falsified medical records and reports of adverse events related to Essure, United States Representative Mike Fitzpatrick (R-PA) will introduce the E‑Free Act, seeking FDA withdrawal of the device.
The Essure device is a contraceptive device that is inserted into the fallopian tubes in order to create a blockage, permanently preventing pregnancy. An estimated 750,000 women have received the contraceptive since 2002. The procedure involves two coils that get inserted into the fallopian tubes. The coils are made of nickel-titanium alloy, which can potentially cause allergic reactions in some patients.
Beginning in 2003, the Food and Drug Administration has received thousands of complaints from Essure users. Women cited pain and bleeding long after the initial procedure. Some potential complications of the device are bowel perforations, device migration, and the device breaking into pieces. This can lead to pain, bleeding, and unwanted pregnancies, among other things. For some women, the pain has become a constant in their everyday lives. Women who underwent a procedure to obtain Essure are ten times more likely to go in for another surgery within the first year.
At Fleming | Nolen | Jez, L.L.P., we believe that you should not have to suffer for someone else’s negligence or inattention. Medical device manufacturers have a responsibility to provide quality products. Devices should not be made available to the public if they cause lasting harm and injuries. If you or a loved one has had an Essure device implanted and are experiencing complications, contact our Houston product liability attorneys today. You can also call toll free 1-866-977-6671 for a free consultation and case evaluation by one of our defective product lawyers.