The agency is reviewing information from an advisory panel meeting on September, as well as additional adverse event reports and medical literature published since the meeting.
The FDA said patient health and well-being is its first priority regarding this device and all medical devices:
“This is a high priority issue for the Agency, and we are working expeditiously to conduct an evidence-based review of the available information and identify appropriate next steps.”
The FDA has received over 5,000 reports of women who experienced persistent pain, perforation of the uterus and/or fallopian tubes, pregnancy, device migration into the abdomen, abnormal bleeding, allergic reactions, device removal, and more.
The panel expressed a general desire for additional safety information, especially regarding metal sensitivity and allergic reactions. They also discussed the need for additional physician training.
The panel suggested that Essure might pose risks for women with known hypersensitivity to metal, autoimmune disease, history of pelvic inflammatory disease, or those with abnormal uterine bleeding. However, they also agreed that Essure is an important option for women who cannot have laparoscopic or surgical sterilization, so long as they are warned about the risks.