Or, I guess changed my mind? I went from feeling pretty sad and defeated last night to penning this very snarky comment on the FDA’s decision about Essure.
Is the snark too much? I feel like I infused these words with all of my fury and pain from the last three years.
Hello, FDA. How are you doing today? I am in excruciating pain, like I am every day since Essure caused an overgrowth of scar tissue that fused my reproductive system to my digestive system.
I think it’s great that you think Essure should have a black box warning. I sure wish it would’ve had one back when I had mine placed. I wouldn’t have done it. And I would be healthy and at work instead of at home, unable to sit or stand longer than an hour. It’s important that I go to work because I’m a single mother of five children. The company that approves my leave and disability doesn’t understand what is wrong with me and why it can’t be fixed, so my disability pay stopped January 1st.
I also think it’s great that you’ve ordered a safety study of Essure. I’m happy to show you my medical records so that you can see how and why it is unsafe. Oh, but you won’t be doing the safety study. You’re going to let Essure’s manufacturer, Bayer, do it. That seems kind of strange, doesn’t it? Not just because they make money off of Essure, so they already have a pretty big reason to be biased in their study; but did you hear that multiple participants of the initial clinical trials (run, again, by Essure’s manufacturer) reported that their data was falsified in a number of ways? That women who reported pain and bleeding were no longer asked about pain and bleeding subsequently? That women who reported pain had nurses write down that they were not in pain? And some women who filled the forms out themselves had their answers altered? Oh, wait, I remember. You were told that. At the hearing back in September. And your only reference to those accusations in your decision to let the very same people run this “safety study” was that you found no evidence that anyone’s results from the initial clinical trials were falsified. We heard their testimony. But you have no proof to back your claim that the initial clinical trials were not falsified to indicate higher levels of satisfaction and lower levels of pain?
Neither of these reasons (financial, multiple previous accusations of fraud) seemed to warrant an unbiased third party study? What does it take to warrant an unbiased third party study?
And what does any of this mean to people like me, the ones who got Essure back when the only listed side effects were a possible three days of mild cramping? I’m now three years into this hellish journey. These aren’t cramps and they’re not “mild.” One of my ovaries is fused to my rectum. Did you know that ovaries and testicles have similar nerve endings? Would you defend the safety of a product that fuses testicles to rectums?
You had an opportunity to keep this from the market and you blew it. You had an opportunity to remove Essure from the market. You blew it. You could have allowed us the opportunity to be compensated for our horribly damaged bodies, careers, relationships and lives. But you didn’t. You blew it. You blew it worse than the sex workers blew your Deputy of Science at the FDA Center of Devices and Radiological Health back in 2012. (What’s up, Dr. Maisel?) But then, they’re the professionals. We deserve better than what the FDA has to offer.
Here’s the backup for the fellatio call out in the final paragraph: