Essure problems have been prevalent health concerns to women across the United States since the device’s release in 2002. Thousands of women have reported Essure problems, which were allegedly ignored by Bayer HealthCare; this spurred women and activists to ban together to help get the permanent contraceptive banned.

The collaboration reportedly worked. Bayer announced that their permanent birth control method will no longer be sold by the end of 2018.

Plaintiffs and women injured by the device would say the stoppage is due to the numerous Essure problems reported and the negative reputation surrounding it, but Bayer Healthcare’s July 2018 statement said that the device would cease being sold at the end of the year due to declining sales.

Severity of Essure Problems

Approximately 17,000 product liability claims allege serious Essure problems had compounded the health of numerous women and that the device was unreasonably dangerous to patients. The FDA had issued a black box warning to the Essure label in 2016, stating the agency had received numerous reports of Essure problems.

In addition to these injury reports, eight women have allegedly died from the Essure birth control device.

Bayer halted international sales in September 2017, but the Essure birth control will remain on the market in the United States until the end of 2018.

Raising Essure Awareness

In addition to Essure lawsuits, a Netflix documentary also highlighted the severity of Essure problems and the medical device industry. The documentary, released in April 2018 and entitled The Bleeding Edge, analyzed the $400 billion medical device industry and reviewed patient experiences with the Essure birth control device.

This documentary also helped raise the public profile of a group of Essure survivors, calling themselves E-sisters. The group traveled to Capitol Hill to lobby Congress to implement strong legal protections for womens’ health.

E-sisters started out as a Facebook group called Essure Problems, which consisted of approximately 38,000 women who had suffered a wide range of physical and emotional complications from the Essure birth control device.

The group was reportedly created in 2011, when New York resident Angie Firmalino allegedly developed an autoimmune disorder due to an adverse reaction to the Essure birth control device.

E-sisters works as an online support group for women to not only share their Essure problems, but also to advise each other about different options to file legal action or submit an adverse event report to the FDA. Women also advise each other on how to use social media to share their experiences, as well as educating themselves regarding the removal procedure of the Essure birth control device.

The legislation proposed by the group is entitled the “Medical Device Safety Act”. Its passage would essentially give patients the right to pursue litigation.

Due to certain FDA regulations that prevent legal action against various medical device manufacturers, Bayer has argued that they are immune from any Essure injury claims. This act would change the law and would be “retroactively effective and apply to pending civil actions.”

While claimants can file their own Essure injury lawsuit based on their circumstances and damages, the formation of a mass tort would conserve legal costs and streamline claims through the litigation process.