·  Legal News, Analysis, & Commentary

Drugs & Medical Devices

Essure Placement Rate Failure

— October 21, 2015

Essure “permanent” birth control has an unacceptably high rate of placement failure, even when done by those with experience. Yet, the product was approved and this information was buried. Improper placement can result in organ perforation, among other things, and require surgery to remove the device.

It’s clear that Bayer thinks it has the perfect product in Essure “permanent” birth control. That or, more likely, it knows how badly it screwed up and screwed over tens of thousands of women and it just doesn’t care. Take the Essure placement rate failure, for instance.

both in uterus

We all know how badly things can go for women when Essure isn’t placed properly: organ perforation and follow-up removal surgeries are just part of it. This video highlights the remarkable failure rate of this horrible product.

not in reproductive area

These are statements from the panel at the pre-approval meeting:

“All along here, there are problems, and it all revolves around the fact that at the very best, the failure rate to get these in is 12 percent, and I suspect that it could easily be 20 percent among people that don’t do this very often. So even with the 12 percent rate, if women are told that up front, unless there’s some fallback plan, like laparoscopy at the same time, I don’t know why they would accept this.” [Emphasis added]

12 percent

Dr. Noller: “I absolutely agree with that. I guess where I started with my poin was that I think that we have things on labeling later, but it just doesn’t say now that there’s a 1 in 8 chance that this won’t work, and I think women deserve to be told that up front in big letters in a box, you know, this isn’t perfect, and we may find with experience that it’s a whole worse or might be even better with time, but that isn’t in their labeling.”

There is also a Facebook group, Essure Problems, which offers moral support and good information for Essure victims.

Activist Erin Brockovich has created a website, Essure Procedure, in an effort to create change regarding this horrible device.

Join the conversation!