Newly unsealed documents have revealed that Bayer AG failed to report to the Food and Drug Administration (FDA) thousands of complaints of Essure-caused injuries. A July 10, 2020 Bloomberg report revealed that thousands of complaints of injuries linked to Bayer’s Essure contraception device were not reported to the FDA—a practice that began with Conceptus, Essure’s original maker, and continued after the German conglomerate purchased the product from Conceptus in 2013.
Essure was marketed as a safe, non-surgical alternative to tubal ligation for permanent birth control. Women users would receive the small coil device as an implant in their fallopian tubes. The coil was designed to cause scarring that would ultimately block the tube to prevent pregnancy. Unfortunately, the device did more than that. Women with the Essure implants suffered organ perforation, severe pain, miscarriages, and other significant health problems.
When thousands of contraceptive users began complaining about organ damage, pain, and bleeding after using the implant, the FDA imposed restrictions on the device. In 2018, Bayer pulled it from global markets before ceasing U.S. sales in 2018.
To date, California state courts have received filings for more than 27,000 lawsuits emanating from Essure injuries. The lawsuits allege that Bayer was aware of the dangers of their medical device and kept this information from the FDA and the public. A single coordinated proceeding is managing all the cases before Judge Winifred Y. Smith of the Alameda County Superior Court.
Public Justice, a non-profit advocacy group aimed at combatting “social and economic injustice,” filed a motion to enter the case as a “friend of the court” (amicus curiae), requesting that hundreds of documents previously sealed by the court be made available to the public. The records have been obtained and are available for viewing and download at this dropbox site.
They are available for use by other Essure plaintiffs to help prove their cases and hold Bayer accountable for its actions.