Answers to Frequently Asked Questions (FAQ) about Essure, a permanent sterilization implant that has been linked to 10,000 reports of serious side effects.
Frequently Asked Questions (FAQ)
Essure Side Effects
Essure is a permanent sterilization device that was created by Conceptus Inc., which is now a subsidiary of Bayer. It is the only non-surgical sterilization device on the market.
Essure looks like a metal spring. It actually consists of two flexible metal coils. The outer coil is made of nickel-titanium alloy and it expands to anchor Essure in the fallopian tube. The inner coil is made of stainless steel covered in irritating fibers of polyethelene (PET).
Essure sterilizes a woman by blocking the fallopian tubes, which prevents an egg from traveling from the ovaries to the uterus. Each woman receives two Essure implants, one in each fallopian tube. The PET fibers cause irritation and promote scar-tissue formation, which permanently blocks the fallopian tubes within about three months.
Conceptus got approval for Essure in 2002 with a Pre-Market Approval (PMA) clearance. This means the FDA fast-tracked Essure to the market because it was the only non-surgical sterilization device.
PMA clearance gives manufacturers immunity from lawsuits, which is why Bayer has mostly avoided Essure lawsuits. However, PMA can be invalidated if the manufacturer does not meet requirements.
The FDA ordered Conceptus to complete a study on Essure within 5 years of approval. The study was not published until April 2015, nearly eight years after it was due, and it was missing data on 30% of patients. Conceptus also changed medical records. For example, one woman who had extreme pain said the word “extreme” was crossed out and her comfort level was rated as “excellent.”
Essure is less painful and has a faster recovery time than tubal ligation (“having your tubes tied”), but it may have higher long-term risks. A recent study of 52,000 women in New York linked Essure to a 10X increased risk of follow-up surgery — 2.4% of Essure patients needed another surgery compared to 0.2% of tubal ligation patients.
The FDA received 9,900 injury reports between November 2002 (when Essure was approved) through December 2015. Most reports listed multiple injuries, commonly including:
- Pain/abdominal pain (6989)
- Heavier menses/menstrual irregularities (3210)
- Headache (2990)
- Fatigue (2159)
- Weight fluctuations (2088)
- Nickel allergy or patient-device incompatibility (2016)
- Migration of Essure (854)
- Essure breakage (429)
- Essure difficult to remove (280)
- Improper position of ESsure (199)
- Essure difficult to insert (187)
- Pregnancy (631)
- Death (4)
Yes. In February 2016, the FDA placed a Black Box warning label on Essure to warn about persistent pain, perforation of the uterus or fallopian tubes, abnormal bleeding, allergic reactions, and other side effects. The agency also ordered Bayer to conduct new safety studies.
Four deaths have been linked to Essure complications like infection, uterine perforation, and blood clots after a hysterectomy. Furthermore, 294 fetal deaths occurred in women who got pregnant despite Essure.
No. The FDA refused to recall Essure in the United States in 2016. Instead, the FDA updated Essure’s label with a “Black Box” warning, created an optional “Patient Decision Checklist,” and ordered new safety studies.
It is unlikely the FDA will recall Essure, despite over 9,900 reports of injuries and deaths, hundreds of pregnancy losses, and the largest grassroots campaign since the 1990s to get a device off the market. The FDA says Essure remains an important option for a small number of women who choose to be sterilized but can’t have surgery.
Yes. Essure was recalled and banned by the Brazilian health regulator Anvisa in February 2017. The agency warned: “[Essure] is classified as maximum-risk. It can cause changes in menstrual bleeding, unwanted pregnancy, chronic pain, perforation and migration of the device, allergy and sensitivity, or immune-type reactions.”
There are two types of injuries claims associated with Essure — women who needed additional surgery due to surgical complications, and women who had unusual reactions to Essure. In both cases, a complete hysterectomy to remove Essure is often necessary.
Talk to your lawyer about sending a “Preservation Letter” to the pathology department at your hospital.
As of July 2016, lawyers have filed over 30 lawsuits involving at least 1,000 who were injured by Essure. They have asked federal judges to centralize the lawsuits under one judge in a Multi-District Litigation (MDL).
There are no class action lawsuits for women who were injured by Essure. Instead, hundreds of women have filed individual lawsuits.
The amount of time you have to file a lawsuit depends on the state where you live.