Updated to include commentary from Bayer
The controversy around Essure, a small metal coil that’s placed in the fallopian tubes via catheter, has grown in recent years under an increasingly vocal patient advocacy campaign. As product liability lawsuits mounted so did the volume of Bayer’s self-reported adverse events; most of the reports filed last year came from the manufacturer, according to the FDA.
Last month, the federal safety watchdog said it was evaluating the nearly 12,000 adverse event reports it received last year about Essure, a 136% increase over the number of reports logged in 2016. Since its U.S. approval in 2002, the FDA has received a total of 26,773 adverse event reports on Essure.
In early 2016 the agency mandated a post-market study and new labeling for Essure, adding a patient checklist and boxed warning label in November of that year. Today the FDA said that, although Essure sales have fallen -70% in the U.S. since then, it has determined “that some women still are not receiving information about the known risks of Essure before implantation.”
To that end the bureau added another layer to the rules for Essure’s labeling, requiring healthcare providers to review a brochure with patients that both parties must sign.
“Bayer, the device manufacturer, is required to implement the restrictions immediately and ensure that the process going forward results in healthcare provider compliance with the sales restriction,” the agency said in a press release. “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.”
“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,” commissioner Dr. Scott Gottlieb said in prepared remarks. “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,” added CDRH women’s health assistant director Dr. Terri Cornelison. “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.”
The FDA also said it’s requiring Bayer to add clinical sites to the post-market surveillance study to make up for the decline in U.S. procedures, despite tripling its enrollment over the past six months.
Bayer responded to the news by announcing that the FDA had approved a label update for Essure which requires healthcare providers use a patient-doctor discussion checklist before they can sell the product to a patient.
The new labeling indicates that sale and distribution of the device is limited to “healthcare providers who counsel patients according to the approved label,” Bayer said, adding that the benefit and risk profile of the controversial birth control remains unchanged and “positive.”
Bayer said that the patient-doctor discussion checklist was originally added last November, but now includes a subtitle “Acceptance of risk and informed decision acknowledgement” to emphasize the importance of the device, according to a press release.
In September 2017, Bayer cited “commercial reasons” for halting Essure sales outside the U.S., denying that safety or product quality issues drove the decision.