SILVER SPRING, Md.—The U.S. Food and Drug Administration (FDA) issued an order yesterday to restrict the sale and distribution of the Essure device, to ensure that all women considering use of the permanent contraception device are provided with adequate risk information so that they can make informed decisions.
The FDA became aware that some women were not adequately informed of Essure’s risks before getting the device implanted, despite previous significant efforts to educate patients and doctors about the risks associated with this device. The FDA is requiring a unique type of restriction to restrict the sale and distribution of a device and impose additional requirements needed to provide a reasonable assurance of its safety and effectiveness. The FDA is committed to continuing to use its full authorities to ensure the post-market safety of medical products.
Since the FDA ordered Bayer to conduct a post-market study, and add a boxed warning and a patient decision checklist to the labeling, there has been an approximately 70 percent decline in sales of Essure in the U.S. The FDA has determined, however, that some women still are not receiving information about the known risks of Essure before implantation.
“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,” said FDA Commissioner Scott Gottlieb, M.D. “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.”
The new Essure labeling, which will now be legally required when this product is offered to a patient, restricts the sale and distribution of the device to only health care providers and facilities that provide information to patients about the risks and benefits of this device. The patient must be given the opportunity to sign the acknowledgment, and it must be signed by 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.
In addition to the warning, the FDA also required a more comprehensive patient decision checklist be added to the device labeling to provide women considering Essure information about the benefits and risks of this device before deciding to use it. Although Bayer’s post-market study currently has demonstrated adequate progress, including tripling of the total number of enrolled patients over the past six months, the FDA plans to require Bayer to increase the number of participating study sites to account for the declining sales volume.
“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.”
