Essure is a medical device that has been marketed as a safe and efficient alternative to tubal ligation in women who are seeking permanent birth control. However, an Essure FDA warning and reports of the device being banned in other countries have women concerned who have already had the Essure device implanted.

Essure is a small, coil-like medical device that is placed within the fallopian tubes of a woman. This procedure does not need to occur surgically–it can be done vaginally through the uterus. This is one of the benefits, the device makers claim, of their medical device.

When the metal coils are placed into the fallopian tubes, tissue forms around the device and obstructs the fallopian tube. The sperm cannot meet the egg and conception does not occur.

Essure is made of nickel and titanium. After about three months, a doctor can determine whether or not the procedure has been successful and that conception will not occur in the female patient.

Essure is now manufactured by Bayer HealthCare. It was released in 2002 and was approved by the U.S. Food and Drug Administration that year.

However, many women have reported severe adverse side effects including cramping, dizziness, perforation, device migration, vomiting, device expulsion, fainting and hypervolemia.

Essure FDA Warning

In 2016, following many adverse event reports, the FDA released a warning about Essure. According to the Essure FDA warning released on Feb. 29, 2016, stating that “some women may be at risk for serious complications. These may include persistent pain, perforation of the uterus or fallopian tubes from device migration, abnormal bleeding and allergy or hypersensitivity reactions.”

This Essure FDA warning encourages doctors to completely discuss the risks and options with their patients before moving forward with the procedure.

Later that year, in November 2016, the FDA added another Essure FDA warning to the growing list. A black box warning was added to the device explaining the possible risks and side effects. Black box warnings are reserved for those devices that carry the highest potential for complications.

The black box Essure FDA warning states that, “some patients implanted with the Essure System…have experienced and/or reported adverse events including perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity…”

It also says that “if the device needs to be removed… a surgical procedure will be required.”

From the time that Essure was approved in the United States in 2002 until 2015, the FDA received over 5,000 severe adverse event reports from women who experienced complications with Essure. Some women have had to undergo removal of the Essure devices or hysterectomy, and some women have even experienced miscarriage or ectopic pregnancy.

Studies report as many as 300 fetal deaths and as many as 10,500 other adverse events have been linked to Essure.

If you have had an Essure device implanted and have experienced severe complications such as pain, migraines, vomiting or other side effects, you may benefit from speaking with an experienced attorney.