Women all over the United States are fighting against Bayer AG because of their Essure permanent birth control device. Essure, a non-surgical sterilization device for women, has been the subject of severe scrutiny as thousands of women have reported a multitude of adverse events as a result of the device. This past summer, there were a total of 20,000 documented adverse events that were reported by women. Women are even suing the device’s manufacturer after suffering extreme complications while using the device.
Originally marketed as an easy, non-surgical method of sterilization, Essure was designed to have women return to their normal daily lives within the same day. However, the device, which consists of metal coils that are inserted into the fallopian tubes, caused severe injuries for many users. Thousands of reports claim the device perforated the uterus and surrounding organs. Other women revealed that the device traveled from the implantation location to the pelvic region or abdomen.
One of the biggest reasons the device is under fire is the alarming rate of sterilization failures associated with the device. In an initial study of the device following more than 70,000 women, almost 10,000 experienced sterilization failure within the first 5 years of implantation, resulting in unplanned or unsafe pregnancies. Some of these women carried these children to term, while most suffered from miscarriages or stillbirths. Bayer claims that these reports are simply a result of these women failing to show up to their 3-month check-in and not using another form of birth control in the first 3 months of implantation, as recommended.
In 2016, the U.S. Food and Drug Administration (FDA) stepped in in an attempt to regulate some of these adverse events. The first step was to enforce label changes including the addition of a black box warning to make consumers and health care providers are aware of the risks involved. Another major step towards regulation was the creation of the patient decision checklist. This additional pre-implantation step was intended to make consumers better understand the risks that are associated with Essure. Consequently, in 2018, the FDA restricted sales of the device solely to those who reviewed this checklist with their physicians.
Following the decision to restrict sales of the device to only those who reviewed this checklist, Bayer announced that they would be voluntarily halting sales of the device by the end of 2018. America was the last country to discontinue this product, while all other countries banned the product or Bayer themselves pulled the device off the shelves by 2017. This announcement by Bayer came after it was revealed that sales of the device had dropped 70% in just a few months. Even after this announcement, Bayer continued to stand by the safety of their product and claimed that the benefit-risk profile still stands.
During the time that the FDA was getting involved, it prompted a post-market study with Bayer to further assess the risks and benefits of Essure. Originally, this study was supposed to be conducted over the course of 3 years. After the device was discontinued, it was announced that the study would be extended to 5 years with a smaller pool of participants. The reasoning for this extension was due to the lack of women choosing the Essure medical device. The hope of this study is to compare the complications between Essure users and patients who chose traditional tubal ligation procedures.
Women all over the world have been harmed as a result of Essure. Medical Writer Katy Moncivais, PhD, says, “Essure fails every test - it’s less safe, less effective, and more side effect prone than most other methods of birth control.” From exceedingly serious side effects to unplanned pregnancies, Essure has negatively impacted many of the women who were uninformed of the serious nature of the device. Had these women been warned earlier, or better overall, these great adverse events could have been avoided and women could have been spared the pain and suffering endured.
~ Here’s to Your Health & Wellness