Bayer’s implant device Essure under a growing storm cloud

There’s kind of a flip side — both stark and dramatic — to every stated upside concerning Bayer’s longtime industry-leading birth control implant Essure.

The device garnered formal FDA endorsement back in 2002. Despite approval, though, regulators expressed explicit concerns regarding their lack of basic knowledge about the device. A recent Consumer Affairs article stresses that “they knew little about the long-term side effects” relevant to implant-linked procedures.

And there is this, too: Although Essure continues to receive kudos from a select audience of commentators and enthusiasts, growing evidence points to material problems occurring in high numbers for product users. The American College of Obstetricians and Gynecologists steadfastly continues to endorse the implant, while injury-focused data simultaneously piles up to an alarming degree.

To wit: Reportedly, close to 27,000 complaints citing Essure-tied health problems have been filed online with the FDA. And many thousands of Essure product liability lawsuits have been filed across the United States. One research estimate posits more than 300 fetal fatalities linked with Essure implants (a startling and tragic result clearly at odds with Essure’s purpose of preventing pregnancies).

Such adverse information has noticeably put Bayer on edge, with the company likely being additionally rattled by a disparaging documentary on the implant entitled The Bleeding Edge that is imminently scheduled for major release. Bayer executives recently announced that 2018 will be the last year during which Essure will be sold in the United States.

Although advocates’ pressure has resulted in so-called “black box” warnings being affixed on Essure labeling, product opponents want far greater safeguards in place applicable to the implant.

Their bottom-line goal is this: Essure’s flat disappearance globally.