October 15, 2020: The FDA posted the third spreadsheet of reportable adverse events that Bayer submitted under the variance from MDR reporting requirements. 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 webpage after spreadsheets are received from Bayer and reviewed by FDA. Additionally, summary information about the events in each spreadsheet will be accessible in the FDA’s MAUDE database. Bayer will provide quarterly and final analysis reports of the adverse event information, which Bayer will make publicly available.
August 11, 2020: The FDA is providing an update on the adverse event information from the first monthly spreadsheet 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 information in connection with litigation within one year of the date of the variance, unless an extension is granted. 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.
Today, the FDA posted the first spreadsheet of reportable adverse events from Bayer under the variance. The first spreadsheet included a total of 1453 reportable events with the following report type: 53 death reports, 1376 serious injury reports, and 24 malfunction reports. Reports do not necessarily represent unique cases, but rather events identified in comment threads from social media posts, sometimes by the same individual. Among the specific event descriptions reported are pain, pregnancy, foreign body/device fragment in patient, and perforation. The majority of reports (80%) in the spreadsheet are related to potential device removal which is consistent with the MDRs for Essure since 2017. For the 53 death reports, the social media posting dates provided range from the year 2013 to 2019, but none of the death reports provide dates for the reported death events. 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.
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 U.S., 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 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.
Medical Device Reports Received by the FDA Related to Essure (2002-2019)
The FDA conducted a search of the Manufacturer and User Facility Device Experience (MAUDE) database on January 8, 2020. From November 4, 2002, Essure's approval date, through December 31, 2019, the FDA received 47,856 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 2019, Bayer submitted 98.6 percent (98.6%) of the reports received by the FDA.
The total number of medical device reports received related to Essure in 2019 is 15,083. In 2018, the FDA received 6,000 medical device reports related to Essure. In 2017, the FDA received 11,854 medical device reports related to Essure. The nature and severity of the reports in 2019 remain consistent with prior years. In 2017 and 2018, 73 percent (73%) of all submitted reports cited litigation, and in 2019, 95 percent (95%) of submitted reports cited litigation. Litigation reports may reference information previously submitted to the FDA.
In 2017 and 2018, 92.7 percent (92.7%) and 87.5 percent (87.5%), respectively, of all reports received used terms related to device removal. In 2019, 91 percent (91%) 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 medical device reports that mention issues involving potential device removal.
From 2002 through 2019, the most frequently-reported patient problems were pain/abdominal pain (32,901), heavier menses/menstrual irregularities (14,573), headache (8,570), foreign body/device fragment in patient (8,501), perforation (7,825), fatigue (7,083), weight fluctuations (5,980), depression/anxiety (5,366), hypersensitivity/rash (5,077), and hair loss (4,999). 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) (7,515), migration of the device or device component (4,535), device breakage/material fragmentation/fracture (2,297), dislodged or dislocated device (1,797), device operating differently than expected, for example, implant failure or pregnancy (1,058), malposition of the device (381), device difficult to remove (343), and device difficult to insert (335). Multiple device problems can also be listed in each report.
Through December 31, 2019, there have been 65 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 57, 24 reports relate to 22 adult deaths; 24 reports relate to 21 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 3,829 reports of pregnancies in patients with Essure from 2002 through 2019. Some reports contained information on multiple pregnancies or more than one pregnancy loss. Of the total reports: 866 live births were reported; 1,486 did not indicate whether the pregnancy resulted in a live birth or pregnancy loss; and 1,929 pregnancy losses were reported. Some reports contain information on multiple pregnancies.
Among the 1,929 pregnancy losses reported: 481 were reported as ectopic pregnancies; 236 were reported as elective terminations of pregnancies, and 940 were reported as other pregnancy losses. Due to the limited information provided in the reports, FDA cannot determine whether pregnancy loss is due to the device.
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, eighty-five percent (85%) referenced an instance in which the device was removed from a patient (referred to as "device removal reports" from here after).
- Eighty percent (80%) of the device removal reports cite litigation.
- The top six reported reasons in the device removal reports were:
- Pain: 60 percent (60%),
- Genital hemorrhage: 14 percent (14%),
- Device dislocation/migration/expulsion: 12 percent (12%),
- Perforation: 11 percent (11%),
- Suspected allergy to metals: 4 percent (4%), and
- Device breakage: 3 percent (3%).
Most individual reports included more than one reason for device removal.
- Sixty-six percent (66%) of the device removal reports did not provide information regarding patients' outcomes after device removal (or the outcome was unknown).
- Of the 34 percent (34%) device removal reports that did provide information about patients' outcomes:
- Forty-three percent (43%) stated patient symptoms resolved after device removal;
- Forty-five percent (45%) stated patient symptoms partially resolved (meaning only some of the symptoms resolved or symptoms were in the process of resolving); and
- Twelve percent (12%) stated patient symptoms were not resolved or improved.
- Ten percent (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.
- Sixty percent (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.
- Fifty percent (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.