The permanent sterilization device Essure is supposed to prevent pregnancy, but studies have found that up to 9.6% of women get pregnant within 10 years. When pregnancies occur, they can be ectopic (outside the uterus) or end in miscarriage.
Woman Needs Emergency Surgery After Ectopic Pregnancy
ABC 15 talked to Jennifer Gabledon, a woman who got pregnant after getting Essure. One day, she woke up with unimaginable pain that caused her to faint and hit 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.”
Women choose Essure because they don’t want to get pregnant. Essure is a birth control device that is implanted in the fallopian tubes, where it causes scar-tissue growth and inflammation that is supposed to prevent fertilization of egg and sperm.
Essure is over 99% effective at preventing pregnancy when used correctly. Unfortunately, Essure doesn’t always work, often because it was implanted improperly or failed to cause the fallopian tubes to completely scar over.
Pregnancies that occur despite Essure are very serious. Metal coils that extend into the uterus can puncture the amniotic sac or the uterus, causing miscarriage. Essure implants that fail to close the fallopian tubes increase the risk of a life-threatening ectopic pregnancy.
Essure vs. Tubal Ligation
In August 2014, the journal Contraception published a study estimating that 96 out of 1,000 women who get Essure (9.6%) will get pregnant within 10 years — 4X the estimated risk of pregnancy associated with tubal ligation (getting one’s “tubes tied”).
FDA Receives Hundreds of Reports of Pregnancy
Between 2002 and June 2015, the FDA received over 5,000 reports of Essure side effects, including 337 reports of women who got pregnant. The cases include 21 reports involving more than one pregnancy post-Essure placement, 69 involving ectopic pregnancy, 32 reporting a miscarriage, and 19 reporting elective termination of the pregnancy. The FDA has received 5 reports of pre-term fetal deaths caused by a perforation of the amniotic sac or uterus.
Essure increases the risk of having a ectopic pregnancy, which occurs when a fertilized egg starts growing outside the uterus, often inside the fallopian tube. This pregnancy is life-threatening and cannot be continued to birth. If the fallopian tube bursts, a woman will need emergency surgery to stop blood loss.
Ectopic pregnancy symptoms may include:
- Abnormal vaginal bleeding
- Nausea and vomiting
- Lower abdominal pain
- Dizziness or weakness
- Low blood pressure
- Intense pressure in the rectum
- And more