Essure is a permanent birth control device inserted into a woman's fallopian tubes for permanent sterilization. Healthcare providers insert soft, flexible coils into each fallopian tube and over a three-month period, tissue forms around the inserts. The build-up of tissue creates a barrier that keeps sperm from reaching the eggs, thus preventing contraception. Each Essure insert is comprised of a stainless steel inner coil; nickel titanium (Nitinol) expanding, elastic outer core; and polyethylene terephthalate (PET) fibers.
The FDA cleared the Essure system in 2002 through the PMA process. Since that time, thousands of women have registered complaints with the FDA and Bayer concerning serious, life altering complications associated with the device.
Essure presents unique legal and factual issues, including issues related to manufacturer immunity, manufacturing defect, negligent failure to warn, failure of comply with the FDA post-marketing regulations for a PMA device, and unique medical issues related to specific causation.
The Essure Litigation Group is sponsored by Stratos Legal.
The Litigation Group will educate members about Essure and keep them apprised of the status of litigation through litigation group meetings, the group’s list server, and the sharing of materials.