Bayer AG Withdraws Essure from the Market Following FDA Restrictions…

On July 20, 2018, Bayer AG announced plans to withdraw Essure from the market in the face of thousands of lawsuits from women who claimed they have been injured by the permanent birth control...


Company faces thousands of lawsuits from injured women


In the face of increased public pressure from the U.S. Food and Drug Administration (FDA) and a recently released documentary, Bayer AG announced on July 20, 2018, that it would stop selling its Essure permanent birth control devices by the end of this year.


Essure is marketed as a method of providing female sterilization without the need for invasive surgery. Instead, the Essure device is placed into the woman’s fallopian tubes. Over a three-month period, tissue formed around the device creates a barrier to prevent the fertilization of the woman’s eggs.


But in April 2018, the FDA ordered Bayer to restrict the sale and distribution of Essure following reports that “some women were not being adequately informed” of the device’s risks prior to implantation. These risks included bleeding, pain, and organ damage. Indeed, in some cases women needed to undergo a hysterectomy in order to remove the device after suffering constant pain.


In addition to the FDA’s restrictions, Bayer also faced criticism from a Netflix-produced documentary, “The Bleeding Edge,” which followed a number of women who claimed they were injured after receiving Essure devices. Although Bayer continues to publicly deny Essure is defective-and in fact attacked the documentary’s producers-the producers said they took the withdrawal announcement as a vindication of their position.


“If a multibillion dollar corporation backed down in this way, just think of the implications this has for about all the devices out there that no one knows the story about, no one knows the back story,” producer Amy Ziering told Variety.


Bayer’s refusal to acknowledge liability is likely tied to more than 16,000 lawsuits filed by Essure patients against the company. More than 13,000 of these cases are pending before a federal judge in California. Separately, on July 23, 2018, a federal judge in Philadelphia remanded 16 Essure lawsuits back to Pennsylvania state court after finding there was no “federal question” of law involved.


Massachusetts pharmaceutical drug and medical device litigation attorney Michael P. Thornton said there is likely to be even more Essure lawsuits following Bayer’s withdrawal announcement. “We are only beginning to grasp the full scope of the damage caused by Essure to women throughout the country. A device that was supposed to protect women from unwanted pregnancy has become a source of pain and suffering. There is no question that Bayer needs to be held accountable. Simply withdrawing the product from the market may be enough to satisfy the FDA, but victims and their families demand more.”


Release ID: 397189