Essure

Essure Side Effects Lead to 5,093 FDA Complaints

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, there were 5,093 complaints about severe Essure complications. The most common complaint reported was severe abdominal pain.

Essure is a permanent female sterilization device manufactured by Bayer HealthCare. Yet it’s just one of the latest medical applications to face scrutiny, and Essure complications are getting patients up in arms.

What is Essure?

Essure is a non-hormonal, permanent birth control device that’s formed into two coils made from nickel-titanium alloy. According to the manufacturer’s website, a doctor inserts the coils into each of the fallopian tubes. Then after approximately three months, a “natural barrier” is formed. This barrier is designed to prevent pregnancy by keeping sperm from reaching the eggs.

What Women Are Saying

Many women suffering severe pelvic pain as well as other Essure complications are filing lawsuits. Several Facebook groups have a total following of tens of thousands, with one group 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. The mother of four told WFAA news that since she got Essure implanted, her life’s been a “nightmare.” Ervin reportedly suffered from intense pain, weakness, and loss of bowel control. As a result, she was hospitalized twice and sent to the emergency room 15 times.

Device Migration Poses Health Risks

Though Bayer originally listed 23 potential Essure complications or side effects. However, the risk of migration to the lower abdomen and pelvis wasn’t included 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 has 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.

Have You Been Affected by Essure Complications?

Women have reported ectopic pregnancy, device perforation, puncture, device migration, and infection from Essure. If you or a loved one had Essure implanted and experienced severe complications, you may be eligible for financial compensation. Speak with a legal representative today to determine what actions you should take next.