Hundreds of patients who have suffered unexpected Essure problems are seeking compensation from Bayer, the manufacturer of this permanent birth control system.

Essure lawsuits filed by plantiffs who have suffered from Essure problems allege that Bayer knew about the device’s risks and adverse effects that it can cause but failed to disclose them and instead covered them up.

Since its arrival on the market, Essure has been represented as the only permanent birth control for women that uses a nonsurgical procedure. Purportedly, it has been marketed as a safer alternative to tubal ligation.

Bayer had marketed the product throughout its history as being safe and effective. However, women who suffered from Essure problems after having this device implanted have alleged otherwise, claiming instead that Essure seriously damaged their health.

Experts studying Essure’s safety and effectiveness have also reported limitations in clinical studies determining Essure’s safety.

U.S. Food and Drug Administration Announcement

The U.S. Food and Drug Administration recently issued a “black box” warning about alleged Essure problems. A congressional bill was introduced in 2015 seeking a recall on the medical device.

According to the FDA, it has been “examining the growing number of adverse event reports associated with the use of Essure.”

The list of adverse event reports received by the FDA mentions adverse effects and complications such as persistent pain, perforation of the uterus or fallopian tubes, intra-abdominal or pelvic device migration, abnormal or irregular bleeding, and allergy or hypersensitivity reactions.

Between 2015 and 2016, the FDA reports that it received 11,192 adverse event reports of some commonly reported problems. Since the device’s approval by the FDA in 2012, women implanted with the device have reported roughly 15,000 Essure problems and adverse effects and complications from the device. Additionally, more than two dozen Essure related deaths have been reported, according to the FDA.

How Essure Works

The Essure implant is a small, flexible coil. It is made up of titanium alloy and nickel, with a fabric liner. During the implantation procedure, one Essure coil is implanted into each fallopian tube. Scar tissue develops around the implants over the next three months. This scar tissue creates a barrier that prevents pregnancy.

According to Bayer, when Essure functions properly, it is effective 99% of the time.

U.S. FDA On Essure Safety and Effectiveness and Other Clinical Studies

In a study published by the New England Journal of Medicine, researchers reported that Essure’s pre-marketing FDA approval was based on nonrandomized and non-blinded studies to which there was no comparison group, instead of being based upon random and blind studies along with a comparison group to which to compare results.

Additionally, the FDA had convened an Obstetrics and Gynecology Devices Panel, in 2015. The panel recommended that certain women should not use Essure, particularly if they have autoimmune disorders or nickel allergies.