This video contains graphic surgical images. Running about seven minutes in length, this is a perfect example of the reality of Essure for tens of thousands of women around the world. Bayer’s “permanent” birth control device, Essure, was approved by the FDA in the early 2000s. There is evidence that the approval process was flawed, including several citations of Conceptus, Essure’s creator, by the FDA.
Bayer continues, with FDA support, touting the safety and efficacy of the Essure device. As you can see from the video, safe it is most certainly not. However, Bayer’s answer to that is that the injuries you see are not statistically relevant given the number of patients experiencing success with the product.
Bayer’s labelled warnings are inadequate at best. One of the device’s primary materials is nickel and, in 2011, the FDA allowed any warnings of allergic reactions to nickel to be removed from the label. Even when the warning was in place, many doctors refused to test patients for nickel allergy, even when the patients brought up the possibility of an allergy.
The device is causing other serious problems, including organ perforation and adhesions.
Many Essure patients are experiencing tooth and hair loss that is clearly related to the device.
So far, Bayer has been protected from legal action by the level of FDA approval given to Essure. Efforts are underway to strip away the pre-market approval (PMA) status, which would allow injured women to sue. One such effort is the E-Free Act, which would not only strip Essure’s PMA status, but force Bayer to remove the device from the market. There is also a current suit in federal court alleging that Bayer violated the terms of the PMA thus negating its protection.
The E-Free Act will likely be voted on in February and the status of the lawsuit is under review by a federal judge.
If you need additional information, please search this blog using “Essure” as a search term. You can also visit the Essure Problems website. The group also runs a Facebook group.