On December 31, 2018, Bayer stopped selling and distributing the Essure device in the United States. Health care providers can implant Essure up to one year from the date the device was purchased. Bayer will continue to implement the FDA’s restriction on sale and distribution of Essure from April 2018, to ensure women are fully informed of the risks associated with the device.
The FDA continues to take concerns about Essure very seriously; ensuring the safety and effectiveness of medical products is an agency priority and core part of our consumer protection role. Women considering permanent birth control should make fully informed decisions by getting information from their health care provider about the risks and benefits of all options. The FDA continues to believe that, for the majority of women, the benefits of the device, when placed by an experienced health care provider, outweigh the risks, and that Essure’s updated labeling and the sales restriction help to assure that women are appropriately informed of the risks.
The following is an overview of some of the FDA’s efforts to monitor the safety of Essure.
FDA Restricts the Sale and Distribution of Essure
The FDA wants to ensure that each and every woman who receives Essure has been informed of the risks and benefits before getting the device implanted. The FDA has taken steps, including labeling changes in 2016 adding a boxed warning and patient decision checklist, to better inform health care providers and patients about the risks.
The FDA is aware that some women have received the Essure device without being adequately informed of Essure’s risks. In order for this device to meet reasonable assurance of safety and effectiveness, all women considering Essure should receive this important information.
On April 9, 2018, the FDA restricted sales of the Essure device to only doctors and healthcare facilities who use the FDA-approved “Patient-Doctor Discussion Checklist – Acceptance of Risk and Informed Decision Acknowledgement”. Sale and distribution of Essure is limited to healthcare providers who agree to review this checklist with patients, and give them the opportunity to sign it, before Essure implantation. The FDA has approved this new safety measure to ensure that the device meets our standards for a reasonable assurance of safety and effectiveness.
The FDA also approved Bayer’s new labeling that includes:
- The following statement: “The sale and distribution of this device are restricted to users and/or user facilities that provide information to patients about the risks and benefits of this device in the form and manner specified in the approved labeling provided by Bayer.”
- Bayer’s Patient-Doctor Discussion Checklist – Acceptance of Risk and Informed Decision Acknowledgement, which is part of the patient information booklet, and has key items about the device, its use, and safety and effectiveness outcomes, which the patient should be aware of as they consider permanent birth control options.
Ongoing Clinical Study to Gather More Information on Essure Benefits and Risks
In February 2016, the FDA ordered Bayer, the company that makes Essure, to conduct a post-market surveillance (“522”) study to gather more data about Essure’s benefits and risks. The post-market study will provide data to help the FDA to better understand the risks associated with Essure and compare them to laparoscopic tubal ligation. This includes the rates of complications including unplanned pregnancy, pelvic pain and other symptoms, and surgery to remove the Essure device. The study will also evaluate quality of life measures after sterilization.
Following Bayer’s 2018 announcement that it planned to remove Essure from the market, the FDA worked with Bayer to best determine how to move forward to answer the critical questions we posed concerning certain patient complications that may be experienced by patients who have Essure since the company would not meet its expected enrollment numbers. In December 2018, the FDA approved changes to the study plan. The FDA approved a revised study plan that extends Bayer’s mandatory follow-up of women enrolled in the study from three years to five years and continues enrollment of women in the postmarket surveillance study as long as there are devices available in the U.S. The FDA will continue to monitor the performance of Essure in women and will make interim study results and updates available on the Essure Postmarket Surveillance Study page.
The FDA believes clinical data from this postmarket study will help to better understand certain patient complications that women who have Essure permanent birth control may experience when compared to women who undergo tubal ligation. Findings from the study may serve to inform future FDA actions.
Issued Final Guidance to Improve Labeling for Essure and Similar Devices
On October 31, 2016, the FDA issued the final guidance, “Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization” after carefully considering public comments. To view the comments received, go to the Public Docket and search Docket # FDA-2016-D-0435. Updated Essure Labeling Information for Patients and Health Care Providers is available online.
In issuing this guidance, the FDA considered feedback from the 2015 Advisory Committee meeting, as well as comments FDA received through open public dockets. Panel members and the public indicated that medical device labeling for permanent birth control methods, including Essure, is not clear and many patients do not receive enough information before making a decision. Panel members recommended changes to the patient and physician labeling and more aggressive methods to ensure patients are well-informed of risks before choosing a permanent birth control method.
To help address these concerns, the FDA identifies content and format for certain information to be included in the patient and physician labeling to guide conversations between women and their health care providers about the benefits and risks of this type of device:
- A boxed warning with safety statements to better communicate to patients and providers the significant side effects or complications associated with these devices and information about the potential need for removal;
- A Decision Checklist with key items about the device, its use, and safety and effectiveness outcomes, which the patient should be aware of as they consider permanent birth control options.
Completed Evaluation of the Trade Complaint Regarding Allegations Initially Made in a Citizen Petition
The Citizen Petition, which included allegations related to Essure, was referred to the Office of Compliance within the Center for Devices and Radiological Health (CDRH). CDRH closed the Citizen Petition, and the Office of Compliance has completed its investigation of the trade complaint.
Allegations in the trade complaint included clinical trial misconduct, notably that clinical trial participants’ medical records were altered to reflect more favorable data about participants’ experiences. Additionally, the complaint alleged that the sponsor violated the terms of the Premarket Approval (PMA) order and violated laws that relate to the manufacturing and marketing of Essure.
The FDA inspected Bayer as part of the complaint investigation. In addition, Bayer provided the FDA with the available case report forms that documented patient experiences during Essure clinical trials.
The FDA analyzed these forms to evaluate the incidence of cross-outs and discrepancies regarding patient-reported pain, comfort and satisfaction ratings to assess whether modifications favored Essure safety and effectiveness. The Agency found that less than 1 percent of case report form data pertaining to pain, bleeding, device placement/movement and pregnancy were changed during the clinical trials. Although modifications to the case report forms were identified, our analysis did not find evidence the sponsor purposefully modified patient responses to reflect more favorable data for Essure. More information about the Agency’s case report form analysis can be found in the Summary and Key Findings document.
Also as part of the Agency’s complaint investigation, CDRH evaluated Bayer’s labeling of the device, taking into account the allegations in the complaint, as well as the feedback received during the September 2015 Advisory Committee meeting and from public comments received in response to the public docket. With the issuance of the final guidance and the subsequent approval of Bayer’s labeling changes that are consistent with the recommendations in the guidance, the Agency considers its investigation of the trade complaint completed. CDRH Office of Compliance will ensure that Bayer’s revisions to their marketing and promotional materials are consistent with the updated labeling.
Continued Reviews of Reported Problems with Essure
The FDA relies on adverse event and product problem reports, FDA-mandated postmarket studies, and published literature to monitor the safety and effectiveness of medical devices. The FDA continues to review the available information about Essure and the experiences of patients who have had Essure since the FDA approved it in 2002. This includes experiences of patients who have had positive outcomes with Essure as well as those who have experienced problems. Postmarket surveillance activities for Essure include:
Analyzing Essure patient reports of problems (including Web-based testimonials) and reports of problems submitted to the FDA from other sources, including doctors, patients, and the manufacturer of Essure
Adverse event and product problem reports submitted to the FDA are one source the FDA uses to monitor marketed medical devices. These reports may contribute to the detection of potential device-related safety issues as well as to the benefit-risk assessments of these devices. While such reports are a valuable source of information, this type of reporting system has notable limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. This can make it difficult for the agency to confirm whether a device caused a specific event based only on the information provided in a medical device report. Complaints or adverse event reports do not necessarily directly indicate a faulty or defective medical device, and adverse event reports alone cannot be used to establish or compare rates of event occurrence. Additionally, we may receive multiple reports related to the same event, making it difficult to determine actual numbers of events.
The FDA conducted a search of the Manufacturer and User Facility Device Experience (MAUDE) database on February 19, 2019. From November 4, 2002, Essure’s approval date, through December 31, 2018, the FDA received 32,773 medical device reports related to Essure. Most reports received between 2013 and 2015 were voluntary reports submitted from women who received Essure implants. Beginning in 2016, Bayer submitted most of the reports received by the FDA. In 2018, Bayer submitted 89.8 percent of the reports received by the FDA.
The total number of medical device reports received related to Essure in 2018 is 6,000. In 2017, the FDA received 11,854 medical device reports related to Essure. The nature and severity of the reports remain consistent with prior years; however, in 2017 and 2018, 73 percent of all submitted reports cited litigation, and may be referencing reports previously submitted to the FDA.
In 2017 and 2018, 92.7 percent and 87.5 percent respectively of all reports received used terms related to device removal, but some of these reports may not indicate that the device was removed or the date of removal.
On December 20, 2018, the FDA provided an update on the number of device removal reports received between January 2017 to June 2018, the reported reasons for device removal, and reported patient outcome information. The FDA completed an extensive evaluation of medical device reports submitted in 2017 and the first half of 2018 that mentioned issues involving potential device removal to learn more about why women were choosing to have the device removed, which usually requires a surgical procedure. This involved evaluating more than 15,000 medical device reports submitted to the FDA in 2017 through June 2018 on the Essure device. Most of these reports referenced an instance in which the device was removed from a patient, and most came from cases that were made available by plaintiff attorneys as part of litigation against the manufacturer Bayer.
From 2002 through 2018, the most frequently-reported patient problems were pain/abdominal pain (26,244), heavier menses/menstrual irregularities (13,114), headache (8,398), fatigue (6,912), weight fluctuations (5,853), depression/anxiety (5,175), hair loss (4,880), and hypersensitivity/rash (4,807). Most of the reports received listed multiple patient problems in each report. The most frequent device problems reported were patient-device incompatibility (for example, possible nickel allergy) (5,206), migration of the device or device component (3,410), dislodged or dislocated device (1,632), device breakage/material fragmentation/fracture (1,533), device operating differently than expected, for example, implant failure or pregnancy (1,058), malposition of the device (336), device difficult to remove (341), and device difficult to insert (335). Multiple device problems can also be listed in each report.
Through December 31, 2018, there have been 57 reports coded by the submitter as death. Eight of these were incorrectly coded, as there was no indication of death in the report. Of the remaining 49, 17 reports relate to 15 adult deaths; 23 reports relate to 20 incidences of pregnancy loss; five reports relate to five incidents of a death of an infant after live birth; two reports relate to two incidences of ectopic pregnancies (a complication of pregnancy in which the fertilized egg attaches outside the uterus); one report specifies a death but does not indicate whether the death was before or after birth; and one report references an unknown number of deaths posted in social media. It is difficult for the FDA to determine whether the device caused the death with only the information provided in the report.
The FDA has received a total of 2,230 reports of pregnancies in patients with Essure from 2002 through 2018. Some reports contained information on multiple pregnancies or more than one pregnancy loss. Of the total reports: 454 live births were reported; 704 did not indicate whether the pregnancy resulted in a live birth or pregnancy loss; and 1,055 pregnancy losses were reported. Some reports contain information on multiple pregnancies.
Among the 1,055 pregnancy losses reported: 411 were reported as ectopic pregnancies; 145 were reported as elective terminations of pregnancies, and 564 were reported as other pregnancy losses.
Reviewing Results from Post-Approval Studies
Even though Essure is no longer sold in the U.S., the FDA expects Bayer to meet its mandated postmarket obligations concerning this device, which includes two ongoing post-approval studies.
Both ongoing studies are conditions of approval for premarket application supplements in support of labeling modifications. Details on the study protocols and status are posted on the Post-Approval Study Status web page.
Convened FDA Advisory Committee to discuss Essure Safety and Effectiveness
As part of examining safety concerns about Essure raised by patients and cited in Medical Device Reports (MDRs), the FDA convened a meeting of the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee on September 24, 2015 to:
- discuss currently available scientific data pertaining to Essure’s safety and effectiveness,
- hear expert scientific and clinical opinions on the risks and benefits of the device, and
- hear concerns and experiences of women implanted with Essure.
The Advisory Committee meeting summary provides a comprehensive overview of Essure and the FDA’s review, including post-market information, clinical literature and information from ongoing studies.
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