Essure

Essure is a non-hormonal, permanent birth control option for women.It is marketed as the only permanent birth control accessible through a nonsurgical procedure.  Since the device became available in 2002, approximately 750,000 women have used it.  The U.S. Food and Drug Administration (FDA) has received a huge number of complaints regarding issues with Essure from patients and physicians.

In February, 2016, FDA announced that it had issued a brand new mandatory clinical research of Essure and that it might require a boxed warning on the device.

What is Essure and How Does it Work?

Essure is a nonsurgical alternative to tubal ligation.  It’s a permanent birth control.

The Essure insert is a small coil made of a nickel-titanium alloy, stainless steel, and polyester fibers. Rather than through an incision, one coil is placed in each fallopian tubes through the vagina.

The coils embed in the walls of the fallopian tubes. This causes irritation and the growth of scar tissues.  The scar tissue that blocks the tube, preventing sperm from reaching the eggs.  After three months, a confirmation test is used to establish whether the barrier is complete.

Essure Side Effects and Complications

The FDA has received a lot of complaints regarding Essure and there’s a large movement to have the device banned. According to the FDA, there have been four adult deaths and five fetal deaths caused by Essure.

Essure side effects and complications may include:

  • Allergic reaction to nickel released by the coil
  • Coil that migrates through the tubes
  • Migration to other organs
  • Hemorrhaging
  • Perforation of the fallopian tube or uterus
  • Vaginal bleeding
  • Severe cramping
  • Heavier periods
  • Vaginal discharge and infection
  • Abdominal pain
  • Nausea
  • Vomiting
  • Fainting
  • Pelvic pain
  • Back pain
  • Painful intercourse
  • Arm and leg pain
  • Headaches
  • Ectopic pregnancy, which can be fatal

FDA Actions

The FDA approved Essure on November 4, 2002.In September, 2015, the FDA convened an advisory committee interview to go over the security and effectiveness of Essure.  Bayer admitted to having obtained over 17,000 adverse event reports associated with Essure, from women around the globe.  As a consequence of the hearing, the FDA ordered Bayer to run a postmarket surveillance research to collect more information about the benefits and dangers of the device.  The agency also announced that intended to require a boxed warning and Patient Decision Checklist to be added to the Essure label.

In 2016, the FDA announced that it had issued a new mandatory clinical study of Essure and that it would require a boxed warning on the device.

If you were injured by Essure or if you have questions, please email us or call us toll-free at 1-800-HURT-NOW.  We will help you find answers to your questions and we can help you find an attorney who represents Essure victims.

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