Essure Device Safety, What You Should Know

Spokane-OBGYN-Essure

By Dr. Eric Tyler

What is the Essure Device?

The Essure device is a form of tubal ligation that does not involve incisions on the abdomen.  A small scope is placed into the uterus through the cervix and small coils are placed into the fallopian tubes.  Over time, this causes growth of tissue in the tubes that leads to the tubes becoming closed.  Because this process takes time, a confirmatory test is performed at 3 months to ensure the tubes are no longer open.  The Essure cannot be reliably used for contraception without this confirmatory test.

Benefits of the Essure Device

Pregnancy rates are thought to be 0.2% with successful placement of the Essure, making it comparable to, if not superior to, other forms of tubal ligation. Other benefits include quicker recovery time, cost effectiveness, and avoidance of general anesthesia.  As a result, the Essure is a valuable option for women who do not want to undergo a surgical procedure because of the recovery or surgical risks.  There are also many women who simply cannot safely undergo a surgery.

Concerns About the Essure Device

The Essure was approved by the FDA in 2002.  To date, over 750,000 Essure procedures have been performed.  As estimated by reports received by the FDA, the adverse event rate is 0.7%. Unbiased research (not conducted by the manufacturer) indicates the Essure is both safe and effective.  However, many patients and patient groups have raised concerns about the Essure device including persistent pain, perforation of the uterus/tubes, abnormal uterine bleeding, allergic reactions, and unintended pregnancy following Essure placement.  This runs contrary to the wealth of research performed regarding the Essure device. These concerns have led to the FDA calling for further research to readdress the safety and effectiveness of the Essure device.  This research is currently being performed.

What to Make of This…

These contradictory views of the Essure device put both patients and providers in a difficult position, especially when further research is still underway. Because of the value of the Essure device, we cannot simply write it off.  However, it is important for physicians to have a detailed discussion with their patient and ensure they have the knowledge to make an informed decision.  If you are considering tubal ligation, we invite you to have this conversation with us, as our foremost goal is helping you make the decision that is best for you and your family.