Thousands of women who used the Essure sterilization device have been injured by side effects like chronic pain, organ damage, ectopic pregnancy.
Essure is designed to be a permanent implant that blocks the fallopian tubes. The metal coil contains nitinol, which causes inflammation and scar-tissue growth. Essure cannot be removed by pulling it out through the vagina or with laparoscopy.
Women who experience side effects of Essure may need a hysterectomy to remove it from their body. This procedure involves surgical removal of the uterus, fallopian tubes, and ovaries.
In some cases, women can avoid a hysterectomy by undergoing excision surgery. However, because leaving fragments of Essure behind is not a desirable outcome, many doctors recommend a total hysterectomy.
Migration Outside the Fallopian Tubes
Essure is implanted inside the fallopian tube, which carries an egg from the ovary to the uterus in the female reproductive system.
Essure migration outside the fallopian tubes may increase the odds of getting pregnancy. The side effect typically involves one of two scenarios:
- Essure inserted too far: May perforate the fallopian tube and migrate into the pelvis or abdominal cavity due to normal muscle contractions in reproductive system.
- Essure not inserted far enough: May fall into the uterus and cause heavy bleeding and cramping. It may be expelled during menstruation or remain in the uterus.
In September 2015, the FDA issued a 90-page report (PDF) on Essure side effects, including chronic pain. One of the most current studies found that 4.7% of Essure patients reported pelvic pain, 2.7% reported abdominal pain, and 0.7% reported pain during sexual intercourse in the first year of treatment, according to the FDA.
The FDA listed several ways Essure could cause chronic pain:
- Malpositioned device in the fallopian tube
- Uterine or fallopian tubeperforation
- Migration with abdominal or pelvic organ damage
- Tubal pressure
- Nickel allergy with or without local inflammation
- And more
Heavy menstrual bleeding was reported by 16-22% of women in a 5-year follow-up study of Essure. However, few studies have thoroughly investigated the side effect. Longer follow-up studies and case reports suggest 20-30% or more women on Essure experience heavy, prolonged, or frequent bleeding. The FDA has received 867 reports of this side effect.
Essure is a delicate device that consists of a fragile plastic core about the width of pencil lead surrounded by two metal coils. All of these components can fracture and cause side effects like uterine perforation, fallopian tube perforation, internal bleeding, and chronic pain.
Bayer insists that Essure is more than 99% effective at preventing pregnancy with so-called “perfect use.” However, doctors don’t always insert Essure correctly and the fallopian tubes may not be fully blocked. Studies of “real world” use suggest that 9.6% of women could become pregnant within 10 years of getting Essure — nearly 4X the risk of “tube tying” (tubal ligation) procedures.
Miscarriage and Ectopic Pregnancy
Pregnancy on Essure is very serious because the coil could move or puncture the uterus. According to the FDA, there have been five reported fetal deaths (miscarriage) after Essure failed to prevent pregnancy.