On April 9, 2018, the United States Food and Drug Administration issued an order restricting the sale and distribution of the Essure permanent contraception device. The FDA took this step once it became awarethat some women were not “adequately informed” of the risks that come with the device prior to its implantation, despite “previous significant efforts to educate patients and doctors” about the risks associated with the device. Essure is the only permanently implanted birth control device for women on the market that does not require a surgical incision. Some patients implanted with Essure have experienced adverse events, including perforation of the uterus and/or fallopian tubes, migration of inserts to the abdominal or pelvic cavity, persistent pain and suspected allergic or hypersensitivity reactions. In addition, women have also reported experiencing headache, fatigue, weight changes, hair loss and mood changes, such as depression. It is unknown whether these symptoms are related to Essure.
Here, the FDA is requiring a unique restriction by using its authority to restrict the sale and distribution of a device to impose additional requirements needed to provide a reasonable assurance of its safety and effectiveness.
The new Essure labeling will now be required when this product is offered to a patient, including a review and acceptance of the patient brochure, Patient-Doctor Discussion Checklist – Acceptance of Risk and Informed Decision Acknowledgement. The labeling will now restrict the sale and distribution of the device only to healthcare providers and facilities that provide the required information to the patient. The patient must also be given the chance to review and sign the acknowledgement, as well as the physician implanting the device.
Bayer, the device manufacturer, is required to implement the restrictions immediately and ensure that the process going forward results in health care provider compliance with the sales restriction. The FDA will review and monitor Bayer’s plan to ensure the company complies with the restriction. The FDA plans to enforce these requirements and will take appropriate action for a failure to comply, including applicable criminal and civil penalties.
FDA Commissioner Scott Gottlieb, M.D., stated,
“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. We take the concerns of all women affected by Essure very seriously. I’ve personally had the opportunity to meet with several women and hear their important concerns about this product. 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.”
“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,” said Terri Cornelison, M.D., Ph.D., assistant director for the health of women in the FDA’s Center for Devices and Radiological Health. “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.”