Conceptus Inc., a subsidiary of Bayer AG, developed Essure which is a Class III device for permanent surgical sterilization in women. Essure was approved by the Food and Drug Administration (FDA) on November 4, 2002. The device has two metal coils made from polyester fibers, nickel-titanium, stainless steel, and solder which are placed in fallopian tubes to induce fibrosis and block the fallopian tubes to prevent fertilization. Since 2002, it is estimated by Bayer that 750,000 women have received the Essure IUD.
Advantages of Essure as marketed by Bayer
Less Time Procedure
Essure's warning label had noted that the device's nickel can result in allergic reactions, such as itching and hives but in reality, women were found to suffer permanent injuries including autoimmune diseases, perforated organs, and severe pelvic pain. From November 4, 2002, through May 31, 2015, around 5,093 reports of problems connected to Essure were filed with FDA.
While the device’s manufacturer claims Essure is safe and effective, thousands of women disagree. They say the metal coils caused them injuries such as perforation of the fallopian tube, neurological damage, and severe pain. In some cases, women died from complications.