April 12, 2021: The FDA posted the eighth spreadsheet of reportable adverse events for the reporting period of January 2021 that Bayer is required to submit as outlined in the April 24, 2020 variance from MDR reporting requirements. As stated there, the FDA requires Bayer to process all reportable adverse events it becomes aware of in social media in connection with litigation within one year of the date of the variance. The variance is limited to MDR-reportable events for Essure that Bayer is or becomes aware of for the period between November 2016 through November 2020.
As this information is based on social media posts, these reports may reference information already reported to the FDA and do not necessarily represent new adverse events. The FDA will continue to make the adverse event information submitted under the variance publicly available on this web page after spreadsheets are received from Bayer and reviewed by the FDA. Summary information about the events in each spreadsheet is also accessible in the FDA's MAUDE database.
March 15, 2021: Bayer posted the second quarterly analysis report of the adverse event information included in the fourth, fifth, and sixth variance reporting spreadsheets for the reporting time period of September 2020 through November 2020. The second quarterly analysis report includes a total of 11,884 reportable events with the following report type: 11,830 serious injury reports, 45 malfunction reports, and 9 death reports. Reports do not necessarily represent unique cases, but rather events identified in comment threads from social media posts, sometimes by the same individual. The most common patient problems reported were pain, perforation, foreign body/device fragment in patient, pregnancy (including ectopic), heavier periods (menses/hemorrhage), and hypersensitivity. The majority of reports (94%) are related to potential device removal which is consistent with the MDRs for Essure since 2017. For the 9 death reports, the social media posting dates (when provided) ranged from the year 2013 to 2015. None of the death reports provided a date for the reported death event. Based on the limited information in the event descriptions for the reports and the nature of the information, it is difficult to identify duplicate reports within the spreadsheet of events, as well as duplicate reports previously submitted to the FDA. The limited information prevents the ability to draw any conclusions as to whether the device, or its removal, caused or contributed to any of the reported deaths or other events in the reports.
Bayer will continue to provide quarterly analysis reports and a final analysis report of the adverse event information submitted under the variance, which Bayer will make publicly available.
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 reviews the available information about Essure and the experiences of patients who have or had Essure implants. This includes experiences of patients who had positive outcomes with Essure as well as those who experienced problems.
Even though Essure is no longer being sold or distributed in the United States, the FDA will continue to evaluate medical device reports related to Essure and will keep the public informed if new information becomes available.
Adverse event and product problem reports submitted to the FDA are one source the FDA uses to monitor the safety profile of 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 FDA 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, the FDA may receive multiple reports related to the same event, making it difficult to determine actual numbers of events.
Medical Device Reports Received by the FDA Related to Essure (2002-2020)
The FDA conducted a search of the Manufacturer and User Facility Device Experience (MAUDE) database on January 6, 2021. From November 4, 2002, Essure's approval date, through December 31, 2020, the FDA received 63,942 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 2020, Bayer submitted 99% of the reports received by the FDA.
The total number of medical device reports received related to Essure in 2020 is 16,086. In 2019, the FDA received 15,083 medical device reports related to Essure, followed by 6,000 reports received in 2018 and 11,854 reports received in 2017. The nature and severity of the reports in 2020 remain consistent with prior years. In 2020, 91% of all submitted reports cited litigation. In 2019, 95% of submitted reports cited litigation, followed by 73% of all submitted reports citing litigation in 2018 and 2017. Litigation reports may reference information previously submitted to the FDA.
In 2017, 2018 and 2019, 92.7%, 87.5% and 91%, respectively, of all reports received used terms related to device removal. In 2020, 93.5% of reports received used terms related to device removal. Some of these reports may not indicate that the device was removed or the date of removal. The FDA continues to evaluate other sources of postmarket data, including results from mandated postmarket studies, in addition to medical device reports to gather more information about device removals.
From 2002 through 2020, the most frequently-reported patient problems were pain/abdominal pain (37,413), heavier menses/hemorrhage/menstrual irregularities (17,332), foreign body/device fragment in patient (9,855), perforation (8,943), headache (8,676), fatigue (7,182), weight fluctuations (6,068), depression/anxiety (5,731), hypersensitivity/rash (5,291), and hair loss (5,084). Most of the reports received listed multiple patient problems in each report. The most frequent device problems reported were patient-device incompatibility/biocompatibility (for example, possible nickel allergy or patient’s anatomy related to failure) (8,283), migration of the device or device component (5,311), device breakage/material fragmentation/fracture (2,704), dislodged or dislocated device (2,577), device operating differently than expected, for example, implant failure or pregnancy (1,058), malposition of the device (401), device difficult to remove (343), and device difficult to insert (335). Multiple device problems can also be listed in each report.
Through December 31, 2020, there have been 94 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 86, 25 reports relate to 23 adult deaths; 25 reports relate to 22 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 28 reports reference information on 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 4,328 reports of pregnancies in patients with Essure from 2002 through 2020. Some reports contained information on multiple pregnancies or more than one pregnancy loss. Of the total reports: 1,010 live births were reported; 1,598 did not indicate whether the pregnancy resulted in a live birth or pregnancy loss; and 2,169 pregnancy losses were reported.
Among the 2,169 pregnancy losses reported: 566 were reported as ectopic pregnancies; 266 were reported as elective terminations of pregnancies, and 1,068 were reported as other pregnancy losses. Due to the limited information provided in the reports, the FDA cannot determine whether pregnancy loss is due to the device.
Prior to interim results being available from the Essure postmarket surveillance (“522”) study, the FDA completed an extensive evaluation of medical device reports submitted in 2017 and 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 17,000 medical device reports submitted to the FDA in 2017 and 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 January 2017 through December 2018, there were 11,854 medical device reports related to Essure in 2017 and 6,000 reports in 2018. Of those reports, 85% referenced an instance in which the device was removed from a patient (referred to as "device removal reports" from here after).
- 80% of the device removal reports cite litigation.
- The top six reported reasons in the device removal reports were:
- Pain: 60%,
- Genital hemorrhage: 14%,
- Device dislocation/migration/expulsion: 12%,
- Perforation: 11%,
- Suspected allergy to metals: 4%, and
- Device breakage: 3%.
Most individual reports included more than one reason for device removal.
- 66% of the device removal reports did not provide information regarding patients' outcomes after device removal (or the outcome was unknown).
- Of the 34% device removal reports that did provide information about patients' outcomes:
- 43% stated patient symptoms resolved after device removal;
- 45% stated patient symptoms partially resolved (meaning only some of the symptoms resolved or symptoms were in the process of resolving); and
- 12% stated patient symptoms were not resolved or improved.
- 10% of the device removal reports suggest complications directly related to device removal. The most commonly reported complications related to Essure device removal were:
- Device breakage,
- Coil migration,
- Device fragments remaining in the patient,
- Procedural or post-procedural hemorrhage, and
- Uterine or fallopian tube perforation.
- 60% of the device removal reports specified a date in which the device was removed. Device removal reports included explant dates ranging from the year 2003 to 2018.
- 50% of the device removal reports provided both an implant and an explant date. In these reports, the mean and median time from implant to explant were both approximately 4.5 years.
The FDA continues to evaluate other sources of postmarket data, including results from mandated postmarket studies, in addition to medical device reports to gather more information about device removals.
- ESSURE Medical Device Reporting Variance Spreadsheet - January 2021
- ESSURE Medical Device Reporting Variance Spreadsheet - December 2020
- ESSURE Medical Device Reporting Variance Spreadsheet - November 2020
- ESSURE Medical Device Reporting Variance Spreadsheet - October 2020
- ESSURE Medical Device Reporting Variance Spreadsheet - September 2020
- ESSURE Medical Device Reporting Variance Spreadsheet - August 2020
- ESSURE Medical Device Reporting Variance Spreadsheet - July 2020
- ESSURE Medical Device Reporting Variance Spreadsheet - June 2020