Essure is an attractive option for women who want to be sterilized but don’t want surgery. Unfortunately, thousands of women have suffered from debilitating problems like chronic pain, organ damage, allergic reactions, ectopic pregnancy, and more.
Problems With Essure Birth Control
One of the most popular alternatives to tubal ligation (getting one’s “tubes tied”) is Essure, a non-surgical sterilization device that is implanted in a 10-minute outpatient procedure without needing anesthesia.
Essure may be easy to implant in a woman’s body, but it has been linked to devastating long-term problems that can significantly decrease quality of life. After 13 years on the market, the FDA issued a report (PDF) ahead of a meeting to discuss problems with Essure.
The FDA said it had received 5,093 side effect reports by September 2015, many involving the following problems:
- Chronic pain: Possible causes of chronic pain include improper positioning of Essure, organ perforations, allergic reactions, or migration into the abdomen.
- Heavy bleeding: More frequent, prolonged, and severe menstrual bleeding are common problems with Essure.
- Nickel hypersensitivity: Essure’s metal coils are made of Nitinol (nickel-titanium) and it can cause allergic reactions, itching, hives, and autoimmune disorders in rare cases.
- Organ damage: Essure can perforate the fallopian tube or uterus and move into the abdomen, where it can cause further organ damage to the bowel or bladder.
- Migration: Some women have needed emergency surgery after Essure migrated into their abdomen.
- Pregnancy: Essure increases the risk of having a life-threatening ectopic pregnancy. It can also cause a miscarriage by perforating the uterus or amniotic sac.
Essure Problems May Require Follow-Up Surgery
Essure is designed to become permanently embedded in a woman’s body. It cannot be removed the same way it was implanted. When problems occur, often the only way to remove Essure is with a hysterectomy — surgery to remove the uterus and reproductive organs.
In 2015, the British Medical Journal published a study involving 44,000 women who were sterilized in New York between 2005-2013. Researchers found that Essure was associated with a 10X increased risk of needing follow-up surgery compared to tubal ligation. The surgeries were commonly performed to relieve complications like device migration or incompatibility after surgery.
Pregnancy Risks Linked to Essure
Essure is over 99% effective at preventing pregnancy with “perfect use.” However, doctors sometimes implant Essure improperly or it fails to completely obstruct the fallopian tubes, allowing an egg to be fertilized.
A study published in the journal Contraception in August 2014 found that up to 9.6% of women could become pregnant within 10 years of getting Essure — 4X the risk for women who get a tubal ligation.
Pregnancy while Essure is still implanted can be life-threatening for both mother and fetus. Ectopic pregnancies are more likely to occur in women who have Essure. Miscarriage can also occur if Essure perforates the uterus or amniotic sac.
Did Conceptus Hide Problems With Essure?
Conceptus Inc., the manufacturer of Essure, got “fast-track” approval status because there were no other non-surgical sterilization devices on the market. Essure is a Class III (“high risk”) device, and Conceptus had to follow strict scientific protocols when studying its safety. In exchange, the FDA granted Pre-Market Approval (PMA) in 2002, which shields Conceptus from lawsuits under a federal law known as preemption.
Although thousands of women have been injured by Essure, it was not until 2013 that lawsuits began moving forward. Plaintiffs claim the approval for Essure is invalid because Conceptus violated terms of the PMA by falsifying medical records, failing to report side effects, making false claims about safety, and using defective materials.