Dozens of women have are suing Bayer and its related companies over injuries they say were caused by the companies’ “defective” permanent birth control Essure.
Christy Rios, Kelly Straley, Crystal McManamon, and Michelle McKay are just some of the women who filed a lawsuit on July 25 in Madison County Circuit Court against Bayer Corp., Bayer Healthcare LLC, Bayer Essure Inc., and Bayer Healthcare Pharmaceuticals. They allege the companies are guilty of breach of duty by manufacturing actual Essure contraceptives that are different from those detailed in federal specifications.
The women say that as a result of using Essure they have suffered and will continue to suffer severe physical injuries, emotional distress, economic losses and other damages. They claim that Bayer is liable for their injuries because they defectively manufactured Essure, failed to warn of the risks associated with use, failed to properly inform and train physicians of proper management of post-implant complications, failed to report complaints involving device migration and expulsion to the FDA, and failed to document corrective and preventive and corrective actions.
Essure was approved by the Food and Drug Administration (FDA) in 2002 and remains the only non-surgical permanent birth control device on the market. Essure consists of two nickel alloy coils that are inserted into the fallopian tubes where over a period of about three months they build up scar tissue, creating a barrier that prevents pregnancy. The plaintiffs allege that the devices have been linked to tens of thousands of adverse event reports that include allergic reactions, autoimmune reactions, chronic pain and unusual bleeding. The coils can also migrate and puncture the fallopian tube or uterine wall, or expel from the body.
In February, the FDA conducted a safety review and fell short of banning the device, opting instead to place a black box warning on the device and requiring Bayer to collect “real world” safety data.
Source: Madison Record