Essure

Essure Complications Lead to 5,093 FDA Complaints From Women

Essure complications

What was once thought to be a relatively safe birth control solution has become a reportedly serious health risk. From the product’s initial creation in 2002 to the FDA’s investigation in May 2015, women filed 5,093 complaints about severe Essure complications. The most common complaint involved severe abdominal pain.

Essure is a permanent female sterilization device that can cause ectopic pregnancies and internal puncture wounds. Patients are now filing lawsuits against the device’s manufacturer, Bayer HealthCare, due to device complications.

What is Essure?

It’s a non-hormonal, permanent birth control device with two nickel-titanium alloy coils. According to the manufacturer, a doctor inserts the coils into each of the fallopian tubes. After approximately three months, scar tissue forms a “natural barrier” to egg fertilization. This barrier keeps sperm from reaching the woman’s eggs, thus preventing pregnancy.

What Women With Device Complications Say

Many women filing claims allege the device causes severe pelvic pain as well as other Essure complications. Several Facebook groups have garnered a massive following, with one credited for a significant spike in FDA complaints. These women share their Essure symptoms and side effects that the device has caused.

Take Sharolyn Ervin from Euless, Texas. This mother told WFAA news that since she got Essure, her life’s become a “nightmare.” Ervin reportedly experienced intense pain, weakness, and incontinence. As a result, Ervin went to the emergency room 15 times and required two hospital stays.

Device Migration Poses Health Risks

Bayer originally listed 23 potential Essure complications or side effects. However, Bayer didn’t add migration to the lower abdomen and pelvis as a possible risk until 2014. That’s more than a decade after Essure was originally approved by the U.S. Food and Drug Association. Women are citing this Essure side effect as the main source of their health problems.

The FDA held a public advisory meeting about these issues on September 24, 2015. The Obstetrics and Gynecology Devices Panel of the FDA collaborated with experts in the industry and physicians to review data and hear concerns from Essure victims. According to Medscape, the meeting resulted is many expert recommendations regarding patient selection, preimplantation medical counseling, product labeling, postimplantation testing and follow-up, and data collection. Yet, no official decision or vote was made by the panel.

How to Get Justice and Compensation for Your Complications

Women have reported ectopic pregnancy, device perforation, puncture, device migration, and infection from Essure. If you or a loved one experienced severe Essure complications, you may qualify for financial compensation. To check your eligibility for a cash settlement, fill out your free Essure claim evaluation form today. Once you’ve submitted your information, an experienced lawyer will call to explain how to get the justice and compensation you deserve.

Related: Brazil Issues Essure Recall — Could the United States Be Next?