Bayer stopped selling Essure worldwide in 2018 after thousands of women filed lawsuits for severe side effects like chronic pain, heavy bleeding, organ damage, allergic reactions, and more.
UPDATE: Bayer Pays $1.6 Billion Settlement in Essure Lawsuits
On August 20, 2020, Bayer announced that it will pay a $1.6 billion settlement to resolve around 90% of the 39,000 Essure lawsuits the company was facing. The settlement includes Essure lawsuits in California and federal court in Pennsylvania.
FDA Updates “Problems With Essure” Website With Data from 15,000 Adverse Events in 2019
In April 2020, the FDA updated its Problems With Essure website to include data from another 15,000 adverse events that were reported in 2019. Between Essure’s approval in November 2002 through the end of 2019, the FDA has received a total of 47,856 medical device reports related to Essure.
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 Class Action Lawsuit Goes Forward in Philadelphia
Lawsuits by 9 women who were injured by Bayer’s Essure sterilization implant were allowed to proceed by a federal judge in Philadelphia. Click here to read more.
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 United States
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.
What is Essure?
Essure is a permanent non-surgical sterilization device invented by Conceptus Inc., now a subsidiary of Bayer. The Essure insert consists of two metal coils, one made of stainless steel and another of nickel-titanium (Nitinol). These coils are wrapped in polyethylene terephthalate (PET), a type of polyester.
How Does Essure Work?
Essure is implanted into a woman’s fallopian tubes through the vagina. Once in place, the PET fibers cause an inflammatory reaction. After about three months, scar-tissue grows around the coils and blocks of the fallopian tubes, preventing fertilization of an egg.
Essure Side Effects
- Migration of device outside of fallopian tubes
- Perforation of fallopian tubes, uterus, or organs
- Ectopic pregnancy
- Unwanted pregnancy
- Nickel allergy / hypersensitivity
- Fracture device
Study Links Essure and 10X Higher Risk of Surgery
In October 2015, the British Medical Journal published a study linking Bayer’s Essure sterilization implant with a 10-fold increased risk of needing follow-up surgery compared to traditional “tube tying” surgery. Click here to read more.
Essure Victims Report Devastating side Effects
One victim of Essure, Melanie Goshgarian, 37, told ABC News: “I felt like a shark was on the side of my body and wouldn’t let go. My whole body started to change. … I was itchy, my arms were tingling and my legs were tingling. … I was confused all the time.”
Lawmakers Call for Essure Recall
In October 2015, Rep. Mike Fitzpatrick (R-Pa.) introduced legislation to revoke approval for Essure. He and 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.”
Will the FDA Recall Essure?
Probably not. The FDA says Essure may still help women who need to be sterilized but cannot undergo surgery. However, the FDA has ordered new safety studies and strengthened warnings. In 2015, the FDA released a 90-page report discussing its safety. Now, researchers are warning that Essure was approved based on only short-term safety data and insufficient follow-up.
Essure Black Box Warning Label
In February 2016, the FDA ordered Bayer to place a “Black Box” label on Essure with stronger warnings about its side effects. In addition, doctors must give women a “Patient Checklist” to make sure they are aware of the risks. The FDA also required a new clinical trial to determine the risks for particular women.
In October 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.”
FDA Removes Nickel Allergy Warnings
Hundreds of women have experienced inflammatory reactions to nickel in Essure’s metal coils. Because around 10-25% of women are allergic to nickel, the original label on Essure recommended a skin-tests before placement.
In 2011, Conceptus convinced the FDA to remove the warning after determining that the amount of nickel was too small to cause allergic reactions in most women. They estimated that only 1-in-10,000 women would experience side effects related to nickel. The label now states that Essure “could be an option for women with nickel sensitivity.”
Essure Linked to Death of a Woman
On September 19, 2013, a physician reported the death of a woman with Essure. The patient was implanted with Essure earlier this year. When she visited the emergency room complaining of abdominal pain, surgeons found that her cervix, fallopian tubes, and uterus were necrotic. The patient developed an infection, kidney failure, and died of Streptococcal toxic shock syndrome.
Essure Lawsuits Preempted by Federal Law
Conceptus Inc. gained Pre-Market Approval (PMA) for Essure in November 2002. This type of clearance fast-tracked Essure through the approval process because it was the only non-surgical sterilization device on the market. In exchange for following rigorous scientific protocols when studying the safety of Essure, PMA also shielded Conceptus from lawsuits under a federal law known as preemption.
Essure Lawsuits Challenge Pre-Market Approval
PMA is supposed to prevent frivolous lawsuits, but in this case it has left thousands of women without legal remedy after they were injured by Essure. Lawsuits challenging the validity of Essure’s approval cite evidence that Conceptus falsified medical records and hid adverse events from the FDA. In recent years, famed consumer advocate Erin Brokovich has joined women in a campaign to revoke Essure’s PMA and get it off the market.
Essure Class Action
Over 18,000 women who were injured by Essure have joined lawsuits, but not a class action. It is unlikely that an Essure class action will be filed for women with serious injuries. Instead, they are filing individual lawsuits. .
Essure Pulled Off Market Internationally in 2017
Australia — 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.
Canada — 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.
Brazil — In February 2017, Essure was recalled in Brazil and and banned by the health agency Anvisa, which 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.”