The US Food and Drug Administration (FDA) has ordered restrictions to the sale and distribution of the permanent contraceptive device Essure (Bayer) in an effort to ensure that all women who are considering the device be provided with adequate information to make informed decisions — something that is currently not happening, the agency said today. "Despite previous efforts to alert women to the potential complications of Essure, we know that some patients still aren't receiving this important information. That is simply unacceptable. Every single woman receiving this device should fully understand the associated risks," FDA Commissioner Scott Gottlieb, MD, said in a news release. More Meaningful Safeguards The new Essure labeling that was announced today restricts the sale and distribution of Essure only to healthcare providers and facilities that provide information to patients about the risks and benefits of this device. The FDA now requires that the Essure patient brochure, titled "Patient-Doctor Discussion Checklist — Acceptance of Risk and Informed Decision Acknowledgement," be reviewed with the prospective patient by the healthcare provider to ensure that the patient understands the risks, benefits, and other information about Essure implantation. The patient must be given the opportunity to sign the acknowledgment, and it must be signed by the physician who implants the device. Bayer is required to implement the restrictions immediately and to make sure that healthcare providers comply with them. Marketed as a nonsurgical alternative to tubal ligation, Essure is a small, flexible metal coil that fits into each fallopian tube through the cervix and uterus. The ensuing inflammation and scarring permanently seal each tube within 3 months. Since its approval in 2002, the FDA has received reports of adverse events with the device. This led the agency to add a boxed warning to the Essure label about the risk for implant perforation, device migration, allergic reaction, pain, and other possible adverse events. A patient decision checklist was also added to the label, which led to a decline of about 70% in sales of Essure in the United States. However, some women are still not receiving information about the known risks associated with Essure before undergoing implantation of the device, the FDA said today. "We've been closely evaluating new information on the use of Essure, and based on our review of a growing body of evidence, we believe this product requires additional, meaningful safeguards to ensure women are able to make informed decisions about risk when considering this option," Gottlieb said. "Ensuring informed decision making is just one important step in our ongoing efforts to monitor this device. We remain committed to carefully and thoroughly considering all new data and evidence and will continue to work with patients affected by this device as part of our process," Terri Cornelison, MD, PhD, assistant director for the health of women in the FDA's Center for Devices and Radiological Health, said in the release. "While some women may continue to choose Essure as their birth control option based on current information, as new information becomes available, the FDA will continue to keep the public informed of the agency's evaluation and findings, and consider regulatory options that appropriately balance benefits and risks for Essure," Cornelison said. On March 7, the FDA provided an update on its ongoing safety review of Essure. As reported by Medscape Medical News, the FDA said it was actively evaluating a "significant collection" of new medical device reports that had been submitted to the agency regarding the device. Of the nearly 12,000 reports received in 2017 for Essure, the majority were sent to the FDA in the last quarter of the year. In September 2017, Bayer announced that it was halting sales of Essure outside the United States. It said its decision was based on commercial, not safety, reasons. Source
