Essure Lawsuit

What is Essure?

Essure is a hysteroscopic sterilization procedure, a type of tubal sterilization that does not require an incision. If a woman undergoes the Essure birth control procedure, a soft metal spring-like device wound with synthetic fibers is implanted in her fallopian tubes. The metal part of the device consists of a stainless steel inner coil and an expanding nickel titanium outer coil. The fibers are used to encourage the surrounding tissue to adhere to the device, ultimately creating a barrier of scar tissue intended to block sperm from reaching the eggs.

Essure Side Effects

Reports of severe complications following the Essure procedure include:

• Additional surgeries, including hysterectomy to remove the device and repair internal organs
• Autoimmune response to the device, including fatigue, rashes, hair loss and weight gain
• Chronic pelvic pain
• Fetal Death
• Life-threatening ectopic pregnancy
• Migration of the device or a device component (in some cases, the device may even ‘disappear’ in the body, becoming undetectable even through standard scanning)
• Expulsion of the device
• Perforation or tear of pelvic organs, including uterus or colon
• Severe migraines and allergic reactions to the device or device components

Fidelma and Carmen have experience representing women alleging harm by defective medical devices, including transvaginal mesh and Mirena^®, as well as potentially harmful medical drugs, including various types of birth control such as Yaz^®.

Complaints about Essure

From the time Essure was approved by the FDA in 2002 to December 31, 2015, the FDA has received 9,900 reports from doctors and women that the permanent birth control device has caused serious side effects, including 11 deaths, five of which were for fetal deaths that occurred in women who became pregnant after the Essure procedure. As a result, in June 2015, the FDA updated the number of adverse event reports involving the Essure system on its website, along with the system’s short- and long-term risks, as part of its review of potential Essure problems.

On Sept. 24, 2015, the FDA held a public meeting of the Obstetrics and Gynecology Devices Panel “to discuss the risks and benefits of Bayer HealthCare’s Essure System for permanent female sterilization.”

The panel heard from medical experts as well as from women who have been implanted with the device.

Along with the discussion of possible side effects and injuries from Essure such as ongoing pain, organ perforation, allergic reactions and device migration, the Panel discussed the following:

• The importance of having available health care services that would provide access to nickel allergy tests and physicians trained in Essure system removal
• Making more training available to doctors regarding device complications and removal, including such issues as when physicians should discuss not implanting the Essure system and alternative treatments
• The importance of results from additional studies and data so that adverse events associated with the Essure system can be better understood
• Finding out more about metal reaction/sensitivity in potential Essure candidates

The panel also suggested that "patients with a known hypersensitivity to metal, autoimmune disease, history of pelvic inflammatory disease and those with a history of abnormal uterine bleeding may be less suitable candidates for the Essure system."

Click for the brief summary and the executive summary of the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee meeting.

After thousands of people reported complaints, the FDA announced in February 2016 that it would require Bayer to conduct a clinical study on the safety and efficacy of Essure. In October 2016, the FDA required Bayer to add a black box warning to Essure labelling. Black box warnings are the FDA’s highest level and indicate that a product may cause death or serious injury.

Judge Winifred Y. Smith of Alameda County Superior Court in California ruled in August 2016 that claims brought by 14 women were not expressly or impliedly preempted under federal or state law, allowing the litigation to progress. Judge Smith granted the ruling after hearing arguments presented by Motley Rice appellate attorney Lou Bograd. Later in October, 2016, following an argument by Motley Rice attorney Fidelma Fitzpatrick and co-counsel, Judge Smith ordered that all California cases involving Essure be coordinated for pretrial purposes before her in Alameda County, California. Currently, there are hundreds of women with filed cases before Judge Smith.

Essure History

The Essure permanent birth control system was developed by Conceptus, Inc. (now a subsidiary of Bayer) and underwent the FDA’s phase II and Pivotal Study patient testing between November 1998 and June 2001. The system was approved through the FDA’s Premarket Approval (PMA) process in November 2002. In 2013, Conceptus, Inc. was purchased by Bayer AG and became a fully owned subsidiary of the Germany-based chemical and pharmaceutical company.

In September 2017, Essure Bayer announced plans to halt sales of Essure in all nations outside of the U.S. The decision, announced on Bayer’s French website, was reportedly made due to commercial reasons and is not linked to allegations questioning the safety and efficacy of the device. Read more on the announcement.

In April 2018, FDA Commissioner Scott Gottlieb announced that the agency imposed “unique” restrictions on sales of permanent contraceptive device Essure to ensure women receive detailed information about the device’s risks before being implanted. Restrictions include requiring patients and physicians to sign a document confirming that they’ve received the information.

In July 2018, Bayer announced that it would stop selling Essure in the United States by the end of 2018. The announcement came roughly three months after the FDA imposed “unique” restrictions on sales of the device, requiring patients to sign a document confirming that they received information detailing the risks before being implanted with the device. Read more on the discontinuation. The window on new Essure implantations closed in the U.S. at the end of 2019, as health care professionals were required to implant the devices within one year from the date of purchase. All devices that were not implanted were required to be returned to Bayer.

The FDA announced May 15, 2019 that it had revised its study of the device to focus on long-term effects. The change in focus was prompted by challenges reaching the study’s initial sample size, which relied on newly enrolled patients. New enrollment had steadily decreased since sales of Essure ceased at the end of 2018, the FDA said. The revised study will follow participants for five years, documenting any issues the women face that may cause them to have the device removed. Read more on the study and other FDA updates on Essure. 

Additionally, according to the FDA 1,002 patients were enrolled in its postmarket surveillance (522) study on Essure as of Sept. 1, 2019. The agency previously instructed Bayer to extend the study from three years to five to better understand long-term patient complications associated with the device. Read more.

Essure in the News

Law360 (Aug. 20, 2020): BREAKING: Bayer Pays $1.6B To Settle Suits Over Essure Contraceptive
Bloomberg (Aug. 20, 2020): Bayer Warned of Essure Complaint Rise Long Before Sales Halt
The Wall Street Journal (Aug. 20, 2020): Bayer Settles Essure Birth-Control Litigation for $1.6 Billion
CNN (July 28, 2018): CNN Exclusive: Bayer paid doctors millions for questionable birth control device
CNN (July 20, 2018): Bayer to stop selling Essure birth control device in US
The New York Times (April 9, 2018): F.D.A. Restricts Sales of Bayer’s Essure Contraceptive Implant
Modern Healthcare (January 10, 2017): California judge outlines next steps for coordinated Essure cases
Modern Healthcare (November 22, 2016): Removing Essure implant poses new risks to patients
New York Times (November 21, 2016): Bayer’s Essure Contraceptive Implant, Now With a Warning
Law360 (August 4, 2016): Calif. State Judge Preserves Essure Injury Claims
Washington’s To News (June 14, 2016): The Guise of Choice: The U.S. Female Sterilization Controversy
Mass Device (May 20, 2016): Study: High-risk women’s health devices approved on faulty data
The Philadelphia Inquirer (July 28, 2015): Another act of gynecological maleficence: The Essure female sterilization coil

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Motley Rice LLC, a South Carolina Limited Liability Company, is engaged in the New Jersey practice of law through Motley Rice New Jersey LLC. Esther Berezofsky is the attorney responsible for New Jersey practice.