A growing number of reports are linking Bayer Healthcare’s popular permanent birth control device, Essure, with serious complications including Essure fetal deaths.

Essure Background

Essure is a form of permanent birth control approved by the U.S. Food and Drug Administration (FDA) in 2002. Essure devices are made up of two metal coils which, during the procedure, are inserted into a woman’s fallopian tubes. The coils are allowed to set for a few months, allowing the tissue to grow in around them. At this point, once the tissue has grown in completely, the fallopian tubes are blocked entirely, intended to prevent pregnancy.

The Essure device is manufactured by Bayer Healthcare, and has long been marketed as a safe and effective method of permanent birth control when compared with similar devices.

As a result of Bayer’s heavy and consistent marketing of Essure as a safer and more effective form of permanent birth control than is competitors, a large number of women are implanted with the device each year. Hundreds of thousands undergo procedures to implant permanent birth control devices each year, and Essure is one of the most popular because of Bayer’s successful marketing tactics, lawsuits claim.

However, a rise in reports over the last year suggesting that Essure is linked with serious complications, including Essure fetal deaths, may be cause for concern. Lawsuits claim that Bayer pushed Essure as safe and effective to boost sales, despite knowing of its serious complications, in order to help pull the company out of debt.

But lawsuits now claim that Bayer (and previous manufacturer, Conceptus) has known from the very beginning of the serious side effects linked with their Essure permanent birth control system, and rather than pull the product or provide patients adequate warning, chose to actively withhold a large amount of safety information pertaining to the device’s risks.

Essure Fetal Deaths

Reports claim that some women implanted with the Essure device have become pregnant despite implantation of the coils. This is in and of itself not unusual, given that there is no form of birth control yet available that is 100 percent effective in preventing pregnancy. However, reports claim that the use of this device may lead to Essure fetal deaths for children that have already been conceived.

According to Representative Mike Fitzpatrick, “thousands of women have filed formal complaints” over Essure issues. Fitzpatrick sent a letter sharing his concerns to the Director of Center for Devices and Radiological Health at the FDA. In the letter, he noted that while the FDA has reported at least five Essure fetal deaths, an independent report of Essure complications has counted far more—a total of 303 Essure fetal deaths, the report claims.

Essure is currently undergoing a Congressional investigation that could serve to take the device off the market.

Filing a Lawsuit Over Essure Fetal Deaths

Plaintiffs allege that, had they been adequately informed of possible side effects of Essure, including Essure fetal deaths, they would never have been implanted with an Essure birth control device and effectively avoided these risks altogether.

If you or someone you love has suffered from Essure complications like Essure fetal deaths, you may be able to file an Essure lawsuit.