Essure Birth Control Safety Issues

The Essure Permanent Birth Control System is a permanent, non-surgical form of birth control for women. The U.S. Food and Drug Administration (FDA) approved Essure in 2002. According to the FDA, as of December 31, 2019, all unused Essure units should have been returned to Bayer and are no longer available for implantation.

Since its 2002 approval, thousands of patients filed complaints about the device. Some of these complaints were for organ perforation. Others involved pelvic pain, unintended pregnancies, abnormal bleeding, and even death.

Conceptus, Inc. was the original manufacturer of Essure. However, Bayer later acquired the medical device company. The device consists of flexible coils inserted through the vagina and cervix into the fallopian tubes. The device irritates the fallopian tube tissue and builds scar tissue around the coil. This creates a barrier that blocks sperm from reaching the egg.

While the device worked for thousands of women, many other women experienced Essure complications. So many women were injured while they had the Essure implant they filed a class action lawsuit.

This article discusses the health problems associated with the device, Essure birth control lawsuits, and theories of liability that affected patients are reporting.

How Many Essure Patients Experience Problems?

According to Consumer Reports, close to 20,000 Essure patients had problems with the device. Of the more than 17,000 patients who reported adverse events, more than half of them had to get surgery to resolve complications. Sadly, many of the women who got sick after having the Essure implant needed a complete hysterectomy.

Approximately 3-4% of Essure patients experienced severe side effects. Many of these patients relied on their doctors to correct the problem. Unfortunately, most doctors don't know how to solve the issue other than implanting more devices. This creates a vicious cycle. The more devices a doctor implants, the higher the risk of the woman getting sick.

Essure Health Problems

Women who had the Essure system implanted reported device breakage. Thousands of affected women reported mild to severe medical complications related to Essure. Some of the reported side effects include:

• Chronic pelvic pain
• Perforation or tears to the pelvic organs
• Life-threatening ectopic pregnancy
• Abdominal pain
• Device migration
• Hysterectomy to remove device and repair damaged organs
• Autoimmune reactions
• Miscarriage
• Severe headaches
• Allergic reactions to the device

FDA Response

The FDA never issued a recall for Essure. However, it did convene a meeting with the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee in 2015 to consider scientific and clinical opinions and patients' experiences.

As a result, the FDA ordered additional clinical testing for Essure and required the company to add a black box warning on the device. It also demanded that the drug manufacturer include a patient decision checklist that doctors must review with patients before prescribing the device.

While the FDA did not recall Essure, Bayer voluntarily removed it from the market in 2018. The company cited declining sales of Essure as the reason. However, one must imagine that the lawsuits also had something to do with it.

Legal Trouble for Bayer

Conceptus originally designed and marketed Essure as a contraceptive device. In 2013, Bayer acquired the company and, therefore, acquired any legal issues surrounding the defective device. Bayer purchased the company even though patients complained about Essure's side effects as early as 2009.

Between 2002 and 2019, more than 47,000 patients notified the FDA of adverse event reports. It wasn't long until victims decided to sue Bayer Healthcare.

Many of the cases were filed or consolidated in California. The U.S. District Court for the Eastern District of Pennsylvania handled many others. Plaintiffs complained that Essure caused severe health problems, including:

• Miscarriage
• Unwanted pregnancies
• Incorrect placement of the device
• Device failure
• Chronic pain of the pelvis
• Rashes
• Cramping

These represent some of the severe complications associated with Essure. Many plaintiffs had to undergo various surgical procedures to correct the problem. Some fared worse. According to the FDA, more than 70 people with the Essure implant died from complications associated with the medical device.

First Lawsuit Related to Essure Birth Control Device

Heather Walsh was the first person to sue Bayer for issues with its Essure birth control device. Her claim, filed in 2013, alleged that one of the metal coils became lodged in her colon. As a result, she underwent a hysterectomy. She also had several additional surgical procedures to remove the coil from her colon.

Walsh reported experiencing extreme and prolonged pain and autoimmune disorders after her doctor implanted the device. She argued that Bayer did not warn doctors or patients about possible complications.

By 2020, more than 39,000 women had sued Bayer for damages. Personal injury attorneys for the plaintiffs demanded compensation for:

• Medical expenses
• Future medical care
• Lost wages
• Pain and suffering

In 2020, Bayer negotiated a settlement of more than 90% of the claims for $1.6 billion. This was about $45,000 per plaintiff. There are few, if any, cases still pending against Bayer for Essure problems.

Product Liability Attorneys Can Help Essure Plaintiffs

If you or a loved one developed severe medical complications as a result of any birth control device or medication, contact an experienced drug and medical device attorney near you today. An experienced attorney can discuss the strengths and weaknesses of your case and advise you on how best to proceed.