Essure Health Problems Led To Bleeding, Pain, Hysterectomy, Lawsuit Claims

A woman who suffered severe pain, bleeding and had to undergo a hysterectomy due to problems from an Essure birth control procedure, has filed a lawsuit against the manufacturer. 

The complaint (PDF) was filed by Marybeth Brown, and her husband, Joshua, in the U.S. District Court for the Southern District of Illinois on April 5.

Brown underwent an Essure procedure in September 2010, which is designed to provide a safe and effective form of permanent birth control. Although a test confirmed proper placement of the device, she began suffering heavy menstrual bleeding, cramping and pelvic pain. When the problems did not otherwise alleviate, Brown had to undergo a hysterectomy and bilateral salpingectomy to have Essure removed, alleging that Bayer failed to adequately warn about the risk that women may experience severe and painful health complications with Essure.

“Defendants’ misconduct and fraudulent concealment of the relevant facts deprived Plaintiff and her physicians of vital information essential to the pursuit of these claims, without any fault or lack of diligence on their part,” the lawsuit states. “Plaintiffs could not reasonably have known or become aware of facts that would lead a reasonable, prudent person to make an inquiry to discover Defendants’ tortious conduct or that her injury was wrongfully caused.”

Essure procedures involve the implant of bendable coils into the Fallopian tubes, which causes scar tissue to form around the coils and block the tubes. However, thousands of women have reported suffering painful and debilitating Essure health problems following the procedures, including migration of the coils, allergic reactions, infections and other problems.

The case joins a growing number of Essure lawsuits filed in recent months, each involving similar claims that Bayer intentionally hid evidence of problems with their device. In many cases, women have required a total hysterectomy to remove Essure after experiencing painful and life-changing problems.

Lawmaker Calls For VA To Stop Purchasing Essure Implants

The lawsuit comes as Pennsylvania Congressman Mike Fitzpatrick is calling for the Department of Veterans Affairs and the Department of Defense to stop purchasing the Essure for use on VA patients due to the health risks.

In a letter, sent last month, Fitzpatrick noted that thousands of women have suffered problems with Essure, and said the device is too dangerous to be used on veterans.

“We should not allow the Department of Veterans Affair to purchase and implant this dangerous device in our veterans,” he wrote. “We should not be utilizing taxpayer resources to purchase a device that has caused so much harm for so many families.”

Fitzpatrick, who previously proposed the E-Free Act to have the device’s FDA approval revoked, has criticized the FDA for not taking strong enough actions to protect women from the device.

Last year, the FDA held advisory panel meetings to review the safety of Essure. After considering recommendations from the panel of outside experts, the FDA announced in late February 2016 that the product will be allowed to remain on the market. However, Bayer was required to place much stronger Essure warnings in a prominent black box on the label, to make sure doctors and women are informed of the potential risks.

Bayer has also been ordered to conduct additional studies to better understand the safety of the Essure implant, raising questions about why the manufacturer failed to take these steps years ago after receiving complaints.

An estimated 750,000 women worldwide have undergone Essure sterilization procedures since the device was introduced in 2002. Bayer purchased the Essure product from the original developer, Conceptus, for about $1.1 billion in 2013.

As Essure injury lawyers continue to review and file potential cases for women nationwide, it is ultimately expected that Bayer could face several thousand lawsuits in courts throughout the U.S.