Product News and Recalls

Internal Documents Show Bayer Underreported Essure Injuries

internal documents show bayer underreported essure injuriesA trove of new documents finally made public show that Bayer did not report a significant number of the reports of injuries it received over its Essure contraceptive device. Touted as a safe alternative to surgical sterilization, Essure would, instead, leave tens of thousands of women with intense bleeding and unbearable pain.

A legal maneuver by advocacy group Public Justice led to the release of the information. The hundreds of pages it obtained show a company that was having intense internal discussions about the safety of a product that it was publicly standing behind, as well as the misdeeds of the company Bayer acquired to obtain the Essure product. That company was called Conceptus and Public Justice’s investigation shows that Conceptus was hard at work concealing Essure’s failures long before Bayer came ringing.

Among its tactics, Conceptus would fail to report situations where Essure had been removed from a patient due to the pain it was causing unless that removal had been deemed “medically necessary.” Additionally, Conceptus would fail to report when the patient’s Essure complaints weren’t resolved after the device had been removed. The company would routinely ignore complaints that originated directly with the patients themselves and Bayer, once it acquired Conceptus, failed to report complaints that had originated prior to the acquisition; even when those complaints met its own internal criteria for what should be reported to the FDA.

Essure was finally removed from US shelves in August of 2018 after receiving what appeared to be every bit of leniency it could obtain from the Food and Drug Administration. Facing everything from public backlash to discussions of a ban implemented by the US Congress itself, the agency only ever went so far as to issue a black box warning for Essure, and would later force a rule stating that women being implanted with Essure would have to sign a document with their providers verifying that they had been notified of the device’s risks. Bayer was left in charge of the enforcement of this restriction to sales of its own product and the FDA itself would acknowledge the Essure solution as “unique.”

With over 27,000 Essure lawsuits currently pending in California, these plaintiffs may finally be approaching the ability to fight a fair fight against a corporation that did everything it could to make sure this information never saw the light of day. As stated by Public Justice staff attorney Stevie Glaberson, Bayer’s behavior “underscores the lengths some corporations will go to – including endangering public health – in order to protect their bottom line. It also highlights why the fight to limit secrecy in cases like this one is a critical part of holding companies accountable.”