Essure, a permanent sterilization device made by Bayer, has been linked to thousands of reports of chronic pain, allergic reactions, organ perforation, and more. Over 32,000 lawsuits have been filed by women who were injured.
UPDATE: Bayer Pays $1.6 Billion in Essure Lawsuit Settlements
On August 20, 2020, Bayer said it had reached a $1.6 billion settlement deal that will resolve around 90% of the 39,000 Essure lawsuits the company was facing. The settlement includes lawsuits that are currently consolidated in California and also federal court in Pennsylvania.
FDA Updates “Problems With Essure” Website – 15,000 More Injury Reports in 2019
In April 2020, the FDA updated the “Problems With Essure” website after 15,000 more women reported adverse events in 2019.
Essure may not be on the market anymore, but thousands of women are still being injured. Bayer is required to report these injuries to the FDA.
There were 15,083 new reports submitted in 2019, bringing the total number to 47,856 injury reports between Essure’s approval in 2002 and the end of 2019, according to the FDA.
The most frequently-reported patient problems were:
- pain/abdominal pain (32,901)
- heavier menses/menstrual irregularities (14,573)
- headache (8,570)
- foreign body/device fragment in patient (8,501)
- perforation (7,825)
- fatigue (7,083)
- weight fluctuations (5,980)
- depression/anxiety (5,366)
- hypersensitivity/rash (5,077)
- hair loss (4,999)
The most frequent device problems reported were :
- patient-device incompatibility/biocompatibility (for example, possible nickel allergy or patient’s anatomy related to failure) (7,515)
- migration of the device or device component (4,535)
- device breakage/material fragmentation/fracture (2,297)
- dislodged or dislocated device (1,797)
- device operating differently than expected, for example, implant failure or pregnancy (1,058)
- malposition of the device (381)
- device difficult to remove (343)
- and device difficult to insert (335)
Essure Doctors Paid Millions by Bayer
From August 2013 through December 2017, Bayer paid 11,850 doctors $2.5 million related to Essure for consulting fees and similar services, according to an analysis by CNN. Click here to read more.
Bayer Stops Selling Essure in U.S.
July 2018 — Bayer will stop all sales of Essure implants at the end of the year, making the U.S. the last country where the controversial device was still sold. Bayer stands by the safety and effectiveness of Essure, and claims it was a “business decision” based on a 40% drop in sales.
Essure Recalled in Australia
August 2017 — Essure has been recalled and pulled off the market in Australia for “business reasons,” following numerous reports of women who were severely injured. There will be no further implantations of Essure in Australia.
Bayer Pulls Essure Off Market in Canada
July 2017 — Bayer has withdrawn its birth control implant Essure off the market in Canada due to declining sales. Health Canada issued an advisory about Essure side effects earlier this year. The agency was concerned that patients were not being adequately warned about long-term side effects and other problems. Click here to read more.
Essure Black Box Warning Label
In February 2016, the FDA ordered Bayer to conduct new clinical trials and update the label on Essure to include a “Black Box” warning about severe, debilitating side effects. The FDA also required new safety studies to better understand the risks of Essure.
On October 31, 2016, the FDA finalized the following “Black Box” warning for Essure:
WARNING: Some patients implanted with the Essure System for Permanent Birth Control have experienced and/or reported adverse events, including perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions. If the device needs to be removed to address such an adverse event, a surgical procedure will be required. This information should be shared with patients considering sterilization with the Essure System for Permanent Birth Control during discussion of the benefits and risks of the device.”
What is Essure?
Essure is a non-surgical device that is used for permanent sterilization of women. It consists of a nickel-titanium metal coil and a stainless-steel inner coil wrapped in polyethylene terephthalate (PET) fibers.
How Does Essure Work?
Essure is implanted through the vagina into the fallopian tubes. Once in place, it causes a low-level inflammatory reaction. Over several months, fibrous scar tissue grows around Essure and blocks the fallopian tubes, preventing pregnancy.
Side Effects of Essure
The most commonly-reported Essure side effects in the first year of treatment were back pain (9%), abdominal pain/cramps (3.8%), and painful sexual intercourse (3.6%). The serious side effects include:
- Migration of device outside of fallopian tubes
- Perforation of fallopian tubes, uterus, or organs
- Ectopic pregnancy
- Unwanted pregnancy
- Allergic reaction / hypersensitivity
- Fractured device
Study Links Essure and 10X Risk of Surgery
Women who get Essure are 10X more likely to need follow-up surgery compared to women who undergo traditional “tube tying” procedures, according to a study published in the British Medical Journal.
Only 0.2% of women who got their tubes tied needed surgery, compared to 2.4% of essure patients. Researchers called the results “a serious safety concern.” Conclusions were based on data from over 52,000 women in New York who were sterilized between 2005-2013. Click here to read more
Should the FDA Recall Essure?
Bipartisan lawmakers have called on the FDA to recall Essure. In October 2015, Rep. Mike Fitzpatrick (R-Pa.) introduced legislation to revoke approval for Essure. Rep. Rosa DeLauro (D-Ct.) told the FDA that “Essure’s benefits to not outweigh its risks, and it should be withdrawn from the market.” However, the FDA has refused to recall Essure because it might still help a few women who need to be sterilized without surgery.
Essure Recalled and Banned in Brazil
In February 2017, the Brazilian health regulator Anvisa recalled Essure and banned sales. Bayer has sold around 250,000 Essure implants outside the United States, but Anvisa did not say how many women in Brazil were implanted with Essure. Anvisa issued this warning: “[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.”
How Could Essure Cause Chronic Pain?
General pain and discomfort was reported in 2.9% of women on Essure and hundreds of women have reported chronic pain. According to the FDA, there several ways Essure could cause chronic pain:
- Improperly positioned device in the fallopian tube
- Uterine or fallopian tube perforation
- Migration into the abdomen or pelvic organs
- Tubal pressure
- Nickel allergy with or without local inflammation
Hundreds of Women Report Nickel Allergy and Hypersensitivity
An estimated 10-25% of all women in the United States are allergic to nickel. Essure contains nitinol, a combination of nickel and titanium, and releases tiny amounts of metal that tapers off over time. By September 2015, the FDA has received nearly 900 reports of allergy/hypersensitivity reactions (46% in women with nickel allergies), including 212 reports of women who had Essure removed after allergic reactions.