FDA Orders “Unique” Restriction on Essure

Essure, the permanent birth control device made by Bayer, has come under serious scrutiny in recent years. Concerns over safety and numerous reported complications have contributed to the device being pulled from sale in most global markets, save for the United States. Now, following renewed criticisms from patients and attorneys, the Food and Drug Administration has issued what it calls a “unique type” of restriction on Essure.

The change will restrict Essure sales to doctors and healthcare facilities that provide patients with a specific brochure detailing the risks of the device, specifically referencing possible perforation of the uterus and fallopian tubes, device migration, and allergic reactions to nickel. The FDA added that only patients who read and sign the brochure will be able to have the device implanted.

“Despite previous efforts to alert women to the potential complications of Essure, we know that some patients still aren’t receiving this important information,” FDA Commissioner Scott Gottlieb said in a statement Monday. “This is simply unacceptable.”

This change in policy is likely a result of the FDA’s recent statement about the device, which was delivered following a meeting with concerned patients who were affected by Essure. In the official statement, the FDA revealed that they had received nearly 12,000 reports of complications in 2017. The bulk of these complaints were received in the last quarter of the year, through cases made available by plaintiff attorneys overseeing the litigation.

While this isn’t the outright ban that most advocates and injured parties have been pleading for, it’s further evidence to support the significant risks posed by the device.