March 9, 2017 | Thornton Law Firm What is Essure? Essure is a permanent form of birth control. Bayer HealthCare’s Essure System for female sterilization is a spring-like pair of metal coils wound with synthetic fibers (polyethelene terephthalate) that is implanted into a woman’s fallopian tubes. The metal part consists of a stainless steel core and an expanding nickel titanium outer coil. The fibers encourage the body to form scar tissue around the device, blocking the fallopian tubes (bilateral occlusion), and thus preventing pregnancy. Years of complaints about Essure There have been thousands of complaints from women who have suffered adverse effects after being implanted with the Essure device. There is an Essure Facebook group – Essure Problems – with over 31,000 members. Thousands of women petitioned the FDA to investigate the dangers of the Essure implant. As of December 31, 2015 the FDA had received 9,900 complaints about Essure from patients and doctors. In November 2016, after many years of complaints from consumers, the FDA required Essure to carry a black box warning. Black box warnings are the FDA’s highest level of warning, indicating that the product may cause serious injury or death. The FDA also requires the patient and her physician complete a “Patient Decision Checklist” before the Essure device is implanted. History of Essure The Essure system was developed by Conceptus, Inc. (now a subsidiary of Bayer). From 1998 to 2001 clinical trials were performed. 745 women received the Essure device. At the conclusion of these trials, the FDA approved Essure through the PreMarket Approval Process (PMA) in November of 2002. In 2013 Conceptus was purchased by Bayer AG and is now a fully-owned subsidiary of Bayer. Some of the original clinical trial participants have complained that their clinical trial reports of side effects from Essure were altered by the original manufacturer, Conceptus. Injuries Associated with Essure permanent birth control implant Allergic or hypersensitivity reactions to the device Autoimmune response, including fatigue, hair loss, rashes, swelling, itching, and weight gain Chronic, severe pelvic pain Expulsion of the device Fetal death Hysterectomy Life-threatening ectopic pregnancy Migraines Migration of the device or a device component in the abdominal or pelvic cavity Perforation or tearing of pelvic organs, including fallopian tubes or uterus Surgeries to remove the device and to repair internal organs What can you do? If you or a loved one been injured as a result of receiving an Essure permanent birth control device, you may have a claim for damages. Contact the defective medical device attorneys at Thornton Law Firm for a free, confidential evaluation of your legal rights at 1-888-341-1405. Or tell us your story using our online contact form for a free and thorough evaluation of your legal rights. Trust our Massachusetts defective drug attorneys to help you Contact Attorney Marilyn McGoldrick online or call 1-888-341-1405 for a free consultation with a recognized leader in Massachusetts defective drug and medical device litigation. You have nothing to risk. We offer a fair and accurate assessment of your case.