In July 2018, Bayer announced that it would no longer sell Essure, the permanent birth control device. This decision to halt Essure sales came after thousands of women experienced adverse effects while they were using it. The FDA required Bayer to continue evaluating long-term safety data in women who were still using the device.
Bayer’s latest analysis covers the period between June 1, 2020, and August 31, 2020. More than 7,509 additional events related to the device were reported to the FDA, including 73 deaths, 104 malfunctions, and 7,332 serious injuries. The most common patient issues reported included heavier periods, pregnancy, foreign body/device fragments in the patient, perforation, and pain.
The limited information provided to the FDA by Bayer makes it challenging to draw any conclusions about whether the device itself or its removal contributed or caused any of the events mentioned in the reports.
The FDA says it will continue to evaluate medical device reports and inform the public of any new information as it becomes available, even though Essure is no longer distributed or sold in the United States.
Essure Adverse Events Reports
The sixth reportable adverse events spreadsheet was posted on January 11, 2020, by the FDA. As of April 2020, Bayer is required to submit these reports based on medical device reporting requirements. All reportable adverse events are to be processed by Bayer as the company becomes aware of them. This includes any information found on social media that relates to Essure lawsuits. All Essure medical device reporting events that Bayer was aware of from November 2016 to November 2020 are currently being shared with the FDA.
The information in these reports is only taken from posts on social media that reference information previously reported to the FDA – they do not represent new adverse reactions. Adverse event information will be made public on the FDA website once Bayer receives the spreadsheets and the FDA reviews them. The FDA’s MAUDE (Manufacturer and User Facility Device Experience) database includes summary information about the adverse events described in each spreadsheet.
Essure Medical Device Reports: 2002-2019
On January 8, 2020, the FDA used the MAUDE to search medical reports related to Essure. Essure was approved on November 4, 2002, and ceased production on December 31, 2019. In that time, over 47,856 medical device reports were submitted to the FDA. A majority of the Essure reports the FDA received between 2013 and 2015 were from women who received the implants. Most of the reports Bayer received were submitted to the FDA beginning in 2016. Bayer submitted 98.6% of the reports to the FDA in 2019.
In 2019, there were over 15,083 medical device reports related to Essure. The FDA received over 6,000 medical device reports in 2018 and 11,854 medical device reports in 2017. The severity and nature of the 2019 reports have remained consistent during the last several years. In 2018 and 2017, Essure lawsuits were mentioned in 73% of all submitted reports. In 2019, Essure lawsuits were mentioned in 95% of all submitted reports. Some information in Essure litigation reports may include information that the FDA already has.
In 2018 87.5 % of all reports featured terms related to Essure removal. This percentage increased to 91% in 2019. Many of the reports failed to indicate when the Essure device was removed or if it was even removed at all. The FDA says it will continue to evaluate any reports that mention issues related to Essure removal.
Essure Side Effects Reported by Patients
The most commonly-reported Essure side effects between 2002 through 2019 were:
- Abdominal pain/pain (32,901 reports)
- Anxiety/depression (5,366 reports)
- Fatigue (7,083 reported reports)
- Fluctuations in weight (5,980 reports)
- Foreign device/body fragments in patients (8,501 reports)
- Hair loss (4,999 reports)
- Headache (8,570 reports)
- Menstrual irregularities/heavier menses (14,573 reports)
- Perforation (7,825 reports)
- Rash/hypersensitivity (5,077 reports)
Essure Issues Reported by Patients
Numerous patient issues were mentioned in each report. The following is a list of the most frequent device problems many of the reports mentioned:
- The device was difficult to insert (335 reports)
- The device was difficult to remove (343 reports)
- Device malposition (381 reports)
- Device not operating correctly, such as unplanned pregnancy or implant failure. (1,058 reports)
- Dislocated or dislodged device (1,797 reports)
- Material fracture/fragmentation/device breakage (2,297 reports)
- Migration of a component of the device or the device itself (4,535 reports)
- Patient-device biocompatibility/incompatibility, such as a nickel allergy or failure related to a patient’s anatomy (7,515 reports)
Each report may also include multiple device problems.
Pregnancy While Implanted With Essure
From 2002 to 2019, 3,829 pregnancies were reported to the FDA from patients who received the Essure device. Some reports include information on pregnancy losses or multiple pregnancies. Of the total number of reports received, there were 1,929 pregnancy losses, 886 live births, and 1,486 pregnancies that did not indicate a pregnancy loss or live birth. Multiple pregnancies were mentioned in some reports.
The 1,929 pregnancy losses reported to the FDA include 481 ectopic pregnancies, 236 elective pregnancy terminations, and 940 other pregnancy losses.
Essure Removal Reports: 2017-2018
A complete evaluation of every medical report between 2017 and 2018 was submitted to the FDA. It mentioned problems that involved potential Essure removal so the agency could learn more about why women were removing the device, as it can only be done surgically. Over 17,000 Essure device reports were submitted to the FDA and then evaluated between 2017 and 2018. Reports regarding patients who had the device removed came from legal cases that were part of litigation against Bayer and were made available by plaintiff attorneys.
In 2018, there were 6,000 medical device reports related to Essure and 11,854 reports in 2017. Over 85% of the patients in the reports referenced instances where the device was removed.
- Litigation was cited in 80% of the device removal reports
- The top six reasons reported in the device removal reports included:
- Device breakages (3%)
- Allergies to metals (4%)
- Perforation (11%)
- Device expulsion/migration/dislocation (12%)
- Genital hemorrhage (14%)
- Pain (60%)
Complications related to Essure device removal were mentioned in 10% of the device removal reports. Among them include the following:
- Fallopian tube or uterine perforation
- Post-procedural or procedural hemorrhage
- Device fragments in the patient
- Coil migration
- Device breakage
Essure Birth Control Injury Lawyers
If you used Essure for permanent birth control and experienced any of the complications mentioned above, you should contact our experienced attorneys to discuss your potential legal options. We can help you get the settlement you deserve and will work with you every step of the way to ensure that the manufacturer is held accountable for your injuries.
Call (855) 551-1019 or fill out an online form for a free case evaluation.
- FDA. “Problems Reported with Essure,” U.S. Food & Drug Administration, https://www.fda.gov/medical-devices/essure-permanent-birth-control/problems-reported-essure. Accessed February 4, 2020.
- FDA. “FDA Activities Related to Essure,” U.S. Food & Drug Administration, https://www.fda.gov/medical-devices/essure-permanent-birth-control/fda-activities-related-essure. Accessed February 4, 2020.