Numerous women have had to undergo Essure removal due to post-procedure complications that could only be resolved through revision surgery. While the need for Essure removal is not a rare occurrence, it is not expected by any means and serves as an ideal permanent contraceptive for numerous women.

According to Tubal Reversal, a North Carolina physician’s practice that specializes in reversing permanent sterilization, their doctors performed 125 Essure removal procedures between January 2008 and January 2014. Out of the 125 cases of Essure removal procedures, 89 of these patients requested Essure reversal in order to allow pregnancy while 36 women asked for Essure removal due to adverse side effects.

For some of the women who had to have the Essure device safely removed, a hysterectomy may have been necessary due to the sensitive placement of the metal coils. However, the medical professionals from Tubal Reversal stated that it was fairly unusual for Essure removal to require a hysterectomy procedure.

This statistic is a handful of the thousands of Essure injury reports submitted to the FDA, from women needing to undergo Essure removal due to adverse reactions like inflammation or allergic reactions.

The Essure contraceptive device consists of two metal coils, which are directly implanted inside each of the patient’s fallopian tubes. These coils spur the growth of tissue in the fallopian tubes, which will ultimately block sperm to egg fertilization.

Overview of Essure Complications

The Essure contraceptive was approved by the FDA in 2002, and quickly became well known to the patient population and medical community. The Essure contraceptive is currently the only non-surgical form of female sterilization on the market, providing women a less invasive and more convenient alternative to traditional hysterectomy.

However, there have been reports of the Essure coils causing allergic reactions to patients, frequently blamed on the presence of the metal nickel. Generally speaking, the most frequently reported Essure adverse side effects include but not limited to:

• Abdominal Pain
• Headache
• Fatigue
• Back Pain
• Pain in Arms and Legs
• Vomiting
• Bloating
• Cramps
• Vaginal Infection and Discharge
• Unusual Menstruation
• Body Weight Fluctuations
• Painful Intercourse
• Autoimmune Complications

Patients have also reported the coils perforating the implant site and moving out place, often causing the patient to experience unusual menstruation, severe pain, and device failure.

It is important to note that when the coils move out of place, it could make the woman vulnerable to pregnancy once again. This has reportedly resulted in ectopic pregnancies in the worst cases, in which the fetus forms outside the uterus.

Since the Essure contraceptive’s approval, over 4,500 injury reports have been submitted to the FDA. Consumer advocates have called for the device’s removal from the market, due to the numerous Essure injury reports submitted.

Advocates have also stated the device should not have been allowed on the market because Bayer HealthCare allegedly had an incomplete safety profile. Women who have had to undergo Essure removal often have to contend with permanent alterations to their reproductive health, including the effects of hysterectomy.