Essure FDA Black Box Warning

According to the Food & Drug Administration (FDA), many of the Essure Problems and Essure Side Effects associated with the adverse patient reports and Medical Device reports were also present in the initial clinical studies.  The side effects and medical complications that were present in both the initial study and continuing studies were addressed on the Essure product labeling for both doctors and Essure patients.

However, many women have also experienced an ever-increasing number of Essure side effects and Essure complications like weight gain, depression, pelvic inflammation, metal allergies, abnormal uterine bleeding, and extreme fatigue.  The FDA admitted that these Essure side effects and Essure medical complications were not found in the initial clinical studies and not listed on the Essure product’s labeling.

Accordingly, the FDA held an advisory panel discussion on Essure in September 2015.  Although the FDA recommended that Essure remain an option for women, they called on Bayer to update the Essure product labeling. The FDA required that Bayer more prominently warm women not to get the Essure device if they have metal allergies, a history of pelvic inflammation, or experienced abnormal uterine bleeding. Ultimately, the FDA released its formal findings on Essure in the middle of November 2016.

On November 15, 2016 in a report entitled “Essure Permanent Birth Control System by Bayer Healthcare: FDA Announcement – Label Changes,” the FDA issued a statement instructing that “the Essure labeling now includes a black box warning and Patient Decision Checklist.”  The Essure Black Box warning includes new safety statements to clearly disclaim significant side effects, severe medical complications, and adverse outcomes linked to the Essure device. Bayer was also required to include a patient counseling section on the new labeling. Additionally, the new warning provides a disclaimer for the potential need for Essure removal.

Essure Black Box Warning: This is the FDA’s highest level of warning on a drug or device. The newly included Patient Decision Checklist provides both doctors and potential patients with detailed information about the device, its use, the procedure, as well as the safety and effectiveness of the Essure device.  This Patient Decision Checklist is intended to be utilized in a doctor-patient consultation, providing an opportunity for the potential Essure patient to discuss Essure and consider her sterilization sterilization options.

Essure Adverse Side Effects Reported

The original clinical studies on Essure found that 3% of women experienced some for of internal wall or organ perforation and nearly 3% of them expelled the device completely. In certain instances, doctors could not successfully insert the Essure device into one or both Fallopian tubes. Initially, it appeared that the 5-Year Post-Market Analysis (PMA) study showed that many of the adverse symptom and side effect began to decline after 1 year.  However, 32 women from these studies had to have the Essure device removed, which required surgery.  Some of the women had to have a full hysterectomy or partial hysterectomy to address uncontrollable bleeding, persistent pain, and various other complications.  Yet, the Food and Drug Administration (FDA) re-approved the Essure device after the PMA

In response to the influx of serious Essure side effect reports and serious Essure medical complication reports, the FDA was compelled to reexamine the Essure device.  One of the ways that the FDA collects information on medical devices is through mandatory and voluntary Medical Device Reports from both doctors and patients.  From 2002 to 2015, there were 5,093 Medical Device Reports. In 2013, the number of Essure Medical Device Reports jumped up from the previous trend (highest number of reports since 2004).  Since 2014, the number of adverse reports and Medical Device Reports have grown exponentially.