Essure Investigation Uncovered

This video is just over one year old. It’s a newscast in which the reporter shares information obtained in her investigation of Bayer’s Essure. However, that is not the investigation referred to in this post’s title. The Essure investigation uncovered is actually an FDA investigation of Essure’s original manufacturer, Conceptus. Bayer purchased Essure from Conceptus for $1.1B.

This video is just over one year old. It’s a newscast in which the reporter shares information obtained in her investigation of Bayer’s Essure. However, that is not the investigation referred to in this post’s title. The Essure investigation uncovered is actually an FDA investigation of Essure’s original manufacturer, Conceptus. Bayer purchased Essure from Conceptus for $1.1B.

It boggles the mind that Essure ever made it through the approval process or that the approval wasn’t pulled years ago. Data provided to the FDA by Conceptus was falsified, in some instances reducing the adverse events reported by a staggering number. Conceptus reported 22 incidences of perforation when its internal data showed there were actually 168.

Conceptus was cited by the FDA at least once during the process. The company promised to correct some of the issues presented by Essure. As you’ll see in the video, when the reporter obtained documents from the FDA regarding Conceptus’ promises and subsequent delivery, huge portions of the documents were redacted – meaning they were blacked out and unreadable.

Fast forward to the present as more than 24,000 women suffering from Essure’s horrible side effects wait until February 2016 for the FDA to issue new guidance on the product. The wheels of government turn very slowly, it’s said and this is the perfect example.

The problems being reported by E-Sisters, the women suffering the side effects, are largely the same problems the FDA saw when Conceptus was developing Essure. Pain, bleeding, bloating, rashes, etc. were all reported adverse events in the early 2000s when Conceptus was seeking FDA approval.

Yet, we wait. We wait for the FDA, despite the fact that the side effects haven’t changed since the Conceptus citations were issued. If Conceptus, followed by Bayer, truly fixed the problems, why is the FDA redacting documents? Why are tens of thousands of women still suffering? Why does the FDA need more time to decide what to do about Essure?

There are a lot of questions but sadly, very few answers.