Woman Dies During Essure Implant Procedure, FDA Investigates Complaints

An adverse event report suggests that a woman’s death may be linked to Essure birth control, indicating that she died while the controversial implant was being inserted. 

The report was submitted to the FDA’s Adverse Event Reporting System by Bayer, the manufacturer of Essure.

The company reportedly received information about the potential Essure death from a doctor, and it is at least the fifth fatality associated with the complications from Essure birth control.

Essure is an implant offered as an outpatient procedure by many medical facilities to provide long-term birth control. During the surgery, a doctor inserts bendable coils into the fallopian tubes, passing through the vagina, cervix and uterus. The process thus causes scar tissue to form around the coils over several months, which blocks the tubes, preventing insemination.

According to the adverse event report, a female patient died while the Essure was being inserted into her fallopian tube. The reason for her death is unknown, but she appears to have suffered a 5 mm puncture to her uterus. The puncture was found during the autopsy and it is unclear whether it occurred during the procedure or how it could be linked to her death.

During the procedure, the surgeon noted having a problem finding the fallopian tube opening.

“The operator gently pushed against the side of the uterus (described by the surgeon as probing) adjacent to the opening of the right fallopian tube with the tip of the essure catheter and advanced the catheter up to the black line,” the report indicates. “The patient suddenly coded. Prior to coding the patient was noted to be shaking a lot and experienced generalized seizure activity.”

The company’s analysis noted that a link to the Essure placement procedure cannot be ruled out, though no definitive causal link could be made.

“Preliminary autopsy results showed a perforation in the cornual region of the uterus near the right tube and 500 cc of blood in abdomen,” Bayer officials noted. “The reported uterine perforation was considered serious due to medical importance and is listed according to essure’s reference safety information.”

The report was filed in February, just after a citizen’s petition for an Essure recall was filed with the FDA, noting multiple reports of severe and debilitating problems associated with the implant, including extreme abdominal pain, excessive bleeding and internal organ injuries.

Late last month, the FDA Center for Devices and Radiological Health rejected the petition, saying it was misfiled. However, the petition and its details were forwarded to the FDA’s Office of Compliance, which reportedly will conduct an investigation of the complaints.

Essure Complications

Although the procedure has become increasingly popular, the FDA has received hundreds of adverse event reports over the past year involving side effects of Essure birth control, including instances where women had to undergo a hysterectomy due to complications that may have been experienced.

Concerns over the birth control implant gained substantial media attention over the summer, following Congressional testimony involving an Essure injury during a briefing by the National Center for Health Research that called for legislation to improve the FDA approval process.

Bayer, which bought the original company that designed the Essure implant and now markets the device worldwide, has downplayed the complaints, maintaining that there are relatively few cases out of the Essure implants used worldwide.