Cases

Essure Lawsuit

When you chose to undergo a permanent birth control procedure, you likely do so in full faith that it will result in a safe and effective means of preventing pregnancy. What you might not have known is that procedures involving permanent fallopian tube implants such as Essure® have reportedly caused a host of serious side effects and complications in thousands of women ranging from chronic pelvic pain to even death.

Motley Rice has been on the front lines of Essure litigation for women who suffered severe injuries after being implanted with the device. Medical attorney Fidelma Fitzpatrick currently serves as lead counsel of the Plaintiffs’ Executive Committee for cases coordinated in California state court.

Sept. 19, 2017

Case Update:  ESSURE SALES STOP OUTSIDE U.S.

Essure manufacturer Bayer announced it plans to stop selling Essure outside of the U.S. Read more on the announcement.

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

Contact an Essure Attorney

If you or a loved one underwent the Essure permanent birth control procedure and experienced one or more of these side effects, please contact Motley Rice Essure lawyers Fidelma Fitzpatrick or Carmen Scott by email or call 1.855.638.1552.

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. Read more about the FDA’s announcement.

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.

Essure in the News

Modern Healthcare (January 10, 2017): California judge outlines next steps for coordinated Essure cases

Ringler Radio (November 28, 2016): Inside Essure Litigation

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