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What is Essure?

Essure is a permanent birth control device designed to prevent pregnancy without the need for surgery. Essure is the only type of birth control device on the market designed to permanently prevent pregnancy without surgery. This makes it an attractive option for many women because they can get back to their normal daily activities almost immediately. Essure is made of two small coils that are placed into the fallopian tubes and is intended to cause inflammation and scar tissue that forms and blocks the tubes, preventing pregnancy.

The maker of the Essure device claims it is effective and safe with an easy insertion procedure. Essure is a permanent, non-surgical birth control device designed to prevent pregnancy in women. It is the only one of its kind on the market intended to avoid pregnancy without a surgical procedure permanently. For this reason, Essure is an attractive option for many women, as they can return to their regular activities almost immediately after insertion.

Essure Linked to Complications

Women who wanted to prevent pregnancy permanently and had the Essure device implanted are coming forward to report complications.

Risks of Essure

  • Chronic pelvic pain
  • Heavy bleeding in between periods
  • Bowel Problems
  • Perforation of the uterus or fallopian tubes
  • Unintended pregnancy
  • Unexpected movement of the device

Claims Against Essure

  • Essure has forced a patient to undergo additional and/or revision surgery beyond the implantation
  • Essure was improperly placed during the procedure
  • Essure caused tearing or perforation of the fallopian tubes or nearby organs
  • Essure has moved or migrated after implant surgery
  • Bayer did not give adequate warnings to patients and doctors about the dangerous Essure side-effects
  • Essure was defectively designed and led to severe complications
  • Essure has caused allergic and immune reactions and recurring pain

Essure Lawsuit

Thousands of complaints have been reported to the U.S. Food and Drug Administration by women who rely on Essure for birth control and have suffered from pain and other side effects. Some of these side effects include cramping, bloating, nausea and vomiting, persistent pain in the pelvic cavity, dizziness, bleeding and irregular periods, constant discomfort, skin itching, and much more.

The device has even more severe side effects, including migration of the device, perforation of the uterus and/or fallopian tubes by the device, device breakage, severe allergic reactions, unintended pregnancies, ectopic pregnancies, and even death.

The FDA has received tens of thousands of adverse event reports documenting these side effects. Since Essure is a permanent birth control device, many women who suffer from side effects choose to have hysterectomies to remove the device.

Injured women continue to file Essure lawsuits in state courts all over the country. There have been a few setbacks but, courts have made progress and, cases are being filed in a consolidated docket in the Superior Court for the State of California in Alameda County. California, Illinois, and Pennsylvania courts are in the process of selecting bellwether trial cases and setting trial dates for 2019 and 2020. Both parties are exchanging general discovery and the plaintiffs have taken several depositions of employees from Bayer. Specific plaintiff claims are not expected to begin until early 2020.

Postmarket surveillance studies from the FDA in regards to Essure were completed and interim results were posted on the agency’s website. The study included Essure patients who were at least 21 years of age who have not been pregnant within the past 6 weeks since the beginning of the study. There were 340 Essure patients and 788 laparoscopic tubal sterilization patients who were enrolled in the study at 60 investigational sites in the U.S. According to the early results comparing Essure to laparoscopic tubal ligation, patients using Essure tend to have increased rates of the following:

  • Abnormal uterine bleeding
  • Chronic lower abdominal and/or pelvic pain
  • Hypersensitivity and allergic reactions
  • Autoimmune disorders (new-onset) or autoimmune-like reactions
  • Invasive gynecologic surgeries, including Essure removal surgery

It was also found that pregnancy rates are similar for Essure patients and tubal ligation patients.

November 2002

The FDA approves Essure as a Class III medical device and markets the device as a promising and safe option for female birth control.

2011

Angie Firmalino, now an advocate for women’s health, has her Essure implant removed after it caused severe injuries and constant bleeding. Firmalino began an “Essure Problems” Facebook group and has been featured in the Netflix documentary, The Bleeding Edge, which showcases the fight against Essure.

2014

The FDA orders Essure manufacturer, Bayer, to conduct a new clinical trial based on adverse event reports filed.

2015

Women who were harmed by the device first began filing lawsuits in late 2015.

September 2015

The FDA advisory committee examines Essure’s post-market data and peer-reviewed research. The FDA also receives reports of women claiming they suffered injuries from Essure.

October 2015

Research from The BMJ finds that women with the Essure implant are 10x more at risk of repeat procedures compared to women with tubal ligation.

2016

Significant progress has been made in state courts, and has allowed those lawsuits to proceed. Women harmed by Essure deserve to see their cases play out in court.

November 2016

The FDA requires Essure to be labeled with black box warnings to indicate the dangerous health risks associated with the device.

September 2017

Bayer announces that they will end all Essure sales outside of the United States.

April 2018

Between 2002 and 2017, there were more than 26,700 complaints filed with the FDA about Essure. The large number of adverse event reports the FDA received forced the agency to restrict Essure sales in April 2018.

July 2020

The FDA released interim results for a required postmarket study for Essure. The study compared the side effects of Essure patients and laparoscopic tubal ligation patients. Essure patients were found to have higher rates of several adverse effects.

August 21, 2020

Bayer agreed to pay $1.6 billion to resolve 90 percent of the 39,000 Essure lawsuits that have been filed in the United States.

Updates

References

Shelia Kaplan. “Essure Birth Control Implants”, The New York Times. Accessed April 14, 2019.

FDA. “Essure Permanent Birth Control: Information for Patients”, U.S. Food and Drug Administration. Accessed April 14, 2019.

FDA. “Essure Permanent Birth Control”, U.S. Food and Drug Administration. Accessed April 14, 2019.

Laurie McGinley. “FDA restricts sale of Essure contraceptive device, requires that women be informed of risks”, The Washington Post. Accessed April 14, 2019.

Shannon Firth. “History of a Device: Essure”, MedPage Today. Accessed May 30, 2019.

Devin Namaky, MD. “Should I have an Essure Removal?”, DailyHealthWire. Accessed May 30, 2019.

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