Inadequate Study Of Essure

Study Not Published For Eight Years

Essure, marketed as a permanent birth control method, was approved by the U.S. Food and Drug Administration in 2002. As a requirement of approval, the FDA ordered Conceptus to complete a study of the effectiveness and safety of Essure within the first five years of approval. However, the results of this study were not published until eight years later in 2015. Additionally, the study itself was marred with issues, with only 70 percent of patients being followed for the full five years.

Study Results Show Problems With Essure

The study showed that complications caused by Essure are numerous and include:

  • Autoimmune responses
  • Abdominal pain
  • Heavier menses/menstrual irregularities
  • Bleeding
  • Headache
  • Fatigue
  • Weight fluctuation
  • Device incompatibility
  • Device migration or breakage
  • Allergic reaction to nickel
  • Device malfunction
  • Malposition of the device
  • Unintended pregnancies, including ectopic pregnancies
  • Fallopian tube, uterus and colon perforation

Additionally, three deaths have been reported: one from Group A strep infection post-procedure, another from a uterine perforation and a third from an air embolism when the device was removed.

What To Do If You Have Been Injured

If you or a loved one has been injured by Essure, the dedicated attorneys at Reich & Binstock are here to help. Our attorneys have over 30 years of experience and will help you get the recovery you deserve. Call us at 713-352-7883 or 877-643-3099 toll free. You can also reach out online for more information.