The sterilization device Essure is not always effective at preventing pregnancy. The FDA has received hundreds of reports of women who got pregnant despite Essure, including dozens who had life-threatening ectopic pregnancies or a miscarriage.

Essure Pregnancy Ends in Emergency Surgery

Investigators with ABC 15 spoke to more than a dozen women in Arizona who experienced problems with Essure. One victim got pregnant even after doctors confirmed that her fallopian tubes were fully blocked. She awoke one morning in excruciating pain and fainted, hitting her head on the shower door:

“After fainting two more times, Jennifer’s husband rushed her to the emergency room. Doctors found she had an ectopic pregnancy that burst in her fallopian tube. She underwent emergency surgery that day.”

Essure and Pregnancy

Essure is a sterilization device for women who do not want to get pregnant. Once Essure is implanted in the fallopian tubes, it causes inflammation and scar-tissue growth that blocks the fallopian tubes and prevents conception. With “perfect use,” Essure is over 99% effective at preventing pregnancy.

The problem is that “real world” use is never perfect. Doctors sometimes implant Essure too far or not far enough, leaving metal coils dangling in the uterus. The fallopian tubes may not fully scar over, allowing an egg to pass into the uterus.

These complications may allow pregnancy to occur, sometimes with life-threatening consequences. Essure increases the risk of having an ectopic pregnancy (outside the uterus), which often requires emergency surgery. The metal coils from an Essure implant may also perforate the amniotic sac or the uterus, resulting in miscarriage.

Study of Essure Pregnancy vs. Tubal Ligation

Essure was associated with an increased risk of getting pregnant compared to tubal ligation (also known as getting one’s “tubes tied”) in a study published by Contraception in August 2014. Researchers estimated that up to 9.6% of women with Essure could get pregnant within 10 years, a 4-fold increased risk compared to tubal ligation.

FDA Reviews Pregnancy Risks of Essure

In September 2015, the FDA released a report on Essure side effects, including pregnancy. The agency received 337 reports of women who got pregnant despite having Essure between 2002 and June 2015, including 69 ectopic pregnancies and 32 miscarriages. The FDA has received five reports of fetal death linked to Essure perforating the fetal membrane.

What is an Ectopic Pregnancy?

An ectopic pregnancy occurs when a fertilized egg implants and begins to grow outside the uterus (womb). They can cause the fallopian tubes to burst open, cause life-threatening bleeding.

Symptoms of an ectopic pregnancy:

  • Abnormal vaginal bleeding
  • Nausea and vomiting
  • Lower abdominal pain
  • Dizziness or weakness
  • Low blood pressure
  • Intense pressure in the rectum
  • And more


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