Essure birth control, a metal coil device inserted into the Fallopian tubes to prevent pregnancy, is currently the subject of a mass tort litigation in the United States.
The litigation originally ignited in 2015 when the U.S. Food and Drug Administration (FDA) responded to increased complaints received about Essure by assembling a safety panel that weighed the risks of using the devices as a form of birth control. Not long after, the FDA recommended one of their strongest safety warnings to Bayer— they asked that each Essure device be labeled with a "black box" warning.
Bayer voluntarily discontinued sales and distribution of Essure “for business reasons” back in 2018. The company decided its permanent birth control device was no longer sustainable due to years of declining sales.
The Bellwether Trial for Essure
As of October 2019, roughly 32,000 Essure birth control claims were filed by women against manufacturer Bayer AG. Of those, approximately 27,000 cases were pending in coordinated proceedings before Superior Court Judge Winifred Smith. Judge Smith will preside over the first Essure bellwether trial slated to begin February 18, 2020.
In a Law360 article attorney Fidelma L. Fitzpatrick, who represents women in the litigation, suggests that 2020 will be a trial-heavy year for Essure cases. As the first bellwether trial Essure is involved in starts in February. Opposing parties have been fighting over whether the women's claims are preempted by the Federal Food, Drug, and Cosmetic Act. Therefore she also expects Bayer to raise causation arguments, and will challenge any women who have had issues with Essure.
FDA Updates: Issues Related to Essure Removal
According to the FDA, there were 11,854 medical device reports connected to Essure in 2017 and 6,000 in 2018. Of those reports, 85 percent pointed to an instance where the device was removed from the patient. 80 percent of the device removal reports cite litigation, and the top six reasons in the device removal reports were:
- Pain (60 percent)
- Genital hemorrhage (14 percent)
- Device dislocation/migration/expulsion (12 percent)
- Perforation (11 percent)
- Suspected allergy to metals (4 percent)
- Device breakage (3 percent)
The FDA states that although sales have been halted for Essure birth control in the United States, the agency will continue to assess reports related to Essure removal. You can review all ongoing FDA activities regarding Essure here.
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