Bayer’s sterilization device Essure has been linked to thousands of adverse events, including side effects like chronic pain, allergic reactions, organ damage, pregnancy, and more..
FDA Report on Essure Side Effects
In September 2015, the FDA published a 90-page report (PDF) summarizing studies of Essure side effects, including:
- Chronic pain
- Vaginal bleeding
- Nickel allergy and hypersensitivity (allergic reaction)
- Perforation (fallopian tubes, uterus, organs, etc.)
- Migration in the abdomen
Essure is easy to implant, but it is not easy to remove. Essure is designed to be permanently embedded in the body by causing inflammation and scar-tissue growth. It cannot be pulled out through the vagina. Due to the risk of leaving fractured pieces behind, many doctors recommend a total hysterectomy to relieve side effects.
Essure is supposed to remain inside the fallopian tubes, which connect the uterus and ovaries. Muscle contractions in a woman’s reproductive tract can move Essure out of position, usually for one of two reasons:
- Inserted too far: The fallopian tube bends sharply, and when Essure is pushed too far it can perforate the fallopian tube and migrate into the abdominal cavity.
- Not inserted far enough: Essure can migrate into the uterus and cause severe cramping and heavy bleeding. It may also fail to prevent pregnancy and cause a miscarriage.
Abdominal and Pelvic Pain
One of the most debilitating side effects linked to Essure is chronic pain in the abdomen, back, and pelvis. Recent studies have found that 4.7% of women who get Essure report pelvic pain during the first year. Another 2.7% reported abdominal pain and 0.7% reported pain during sexual intercourse.
How Could Essure Cause Chronic Pain?
- Positioned wrong in the fallopian tube
- Perforation of the uterus or fallopian tube
- Migration into the abdomen
- Organ damage
- Pressure on the fallopian tube
- Allergic reaction to nickel with or without inflammation
- And more
Severe Menstrual Bleeding
The FDA has received 867 reports of women who experienced heavier menstrual bleeding after getting Essure, though the actual number of cases may be even higher. Recent studies suggest that 20-30% or more women who get Essure experience heavy, prolonged, or frequent bleeding.
Fractured or Broken Essure
Essure is a very delicate device with several fragile components. The plastic core is only about the width of pencil-lead and it is surrounded by two metal coils. If any of these components fracture, they can migrate, perforate organs, or cause bleeding and chronic pain.
Essure is advertised as more than 99% effective at preventing pregnancy, but only with so-called “perfect use.” In the real world, doctors sometimes insert Essure incorrectly or it fails to fully block a woman’s fallopian tubes.
Studies have found that up to 9.6% of women get pregnant in the first 10 years of getting Essure — 4X the risk of pregnancy after “tube tying” procedures.
Ectopic Pregnancy & Miscarriage
According to the FDA, five fetal deaths (miscarriages) have been linked to Essure, including several late-term miscarriages. Uterine perforations resulting in miscarriage have also been reported.
Women who get Essure are more likely to have an ectopic pregnancy, where an egg is fertilized and starts to grow in the fallopian tubes. It is life-threatening and often requires surgery.
ABC 15 talked to a woman who had an ectopic pregnancy just four weeks after her doctor confirmed Essure was working properly. She awoke in excruciating pain:
“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.”