Essure Birth Control Implant – Warning!

Essure Birth Control Implant – Warning! FDA warningEssure is a device sold as a permanent, non-surgical birth control solution for women. Manufactured by Bayer HealthCare Pharmaceuticals (Bayer) and approved by the Food & Drug Administration (FDA) in November, 2002, the Essure device consists of small, flexible coils that are placed into the fallopian tubes by a catheter. Once in place, the device is designed to elicit tissue growth in and around the coils to form blockage of the tubes. The tissue barrier formed prevents sperm from reaching an egg; thus, preventing conception. The FDA has received over 5,000 reports of severe complications and unwanted side-effects from patients implanted with Essure. These include pregnancy, ectopic pregnancy, miscarriage, perforation of the uterus or other organs, migration of the device or its components from the fallopian tubes to the lower abdomen and pelvis, severe menstrual cramps and abnormal and/or heavy bleeding, and even death, as some reports have claimed. Other reported effects include vaginal infection, bloating, fatigue, skin allergies, hair loss, chronic pain, headaches, weight gain, and depression, among others. Several women have reported persistent side-effects so severe that they required invasive surgery to remove the implanted device. It has been further reported that many women who have had adverse consequences are having trouble finding a doctor that will perform the complicated removal surgery. Others have experienced pain so severe that a hysterectomy was their only option for relief. Several lawsuits against Bayer are now pending in Courts across the United States alleging the pharmaceutical company intentionally misled women implanted with Essure regarding its safety and actively concealed negative reports about the adverse reactions reported about the device. On March 4, 2016, the FDA issued an update on the agency’s review of the Essure System. In that update, the agency ordered Bayer to conduct a post-market surveillance study to obtain more data about Essure’s benefits and risks. Additionally, the FDA gave notice of its intent to require an expanded warning with the product and provide a “Patient Decision Checklist” for the Essure System to help women understand the risks and benefits of the device. For now, though, the FDA will not consider removing the device from the U.S. market. If you or someone you love has developed side effects from the Essure Implant System, we would welcome an opportunity to review this situation and further discuss the status of these potential claims and cases. Call Attorney Knox Boteler toll free at 1 866 975-7766 or email: .


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