I just read the response sent to one of the victims of the Essure “permanent” birth control device (response pasted below). Honestly, I understand the use of “canned responses.” However, this is appalling. The FDA is ignoring it’s own mandate to Bayer regarding the new study. Fewer than a dozen participants? So, just how soon is this study going to happen? 2020? 2030? Never?
I have covered the Essure problem for over a year now. I have spoken with several of these brave women. They have become my friends. You, as an agency, are complicit in injuring and killing my friends by allowing this device to remain on the market. You should all be ashamed. What happened to the FDA standing tall to keep Americans safe from devices like Essure?
Is it because they’re women? We all know – as disgusting as it is – that women are still treated as second class citizens in many ways. But to say that their very lives aren’t important, that “options” must be preserved, despite the harm Essure has caused? Tell me: How many men would have been allowed to suffer or die had Viagra created half of the issues created by Essure? Let me save you the time doing the math.
If Viagra had harmed/killed men the way Essure is harming/killing women, it would have been off the market faster than you could say “little blue pill.” So, why is Essure still available?
My opinion is that it’s because the Agency, once a guardian of the American people, has become a puppet of the pharmaceutical industry. It is clear that, due to lack of federal funding, most studies of new devices and drugs are funded by the very companies that want those products approved. One only needs to look at the fact that Conceptus concealed approximately 17,000 adverse event reports from the Agency to see that Big Pharma will never be a self-policing industry. And why should it be? That is YOUR job.
As for “options,” what’s wrong with tubal ligation? For that matter, what’s wrong with promoting vasectomy as a safe permanent birth control solution? Again, let me spare you some time.
It’s because there’s no money in it for Bayer. If Bayer was so concerned about preserving options for women, why did it voluntarily pull Essure from the market in a handful of foreign countries? Surely, these “options” are more important than profits, no? No. They aren’t. In all cases, except Brazil (where your counterparts banned Essure), Bayer has cited commercial reasons and declining sales for the market withdrawals.
So, why aren’t sales declining in the U.S.? Likely, it’s because the majority of doctor are not covering the black box warning with women. They are not using the patient checklist you said must be used. Instead, they are going by Bayer’s information and the valuable stamp of approval the FDA gave the product.
It’s time to step up and do the right thing. Essure must be removed from the U.S. market. Nothing less will do the job.
Feel free to see the numerous stories on Essure I’ve published. If you’re interested, I’m including a link to one about vasectomies as an alternative. Yes, it’s written with a humorous slant, but that was designed to broach a topic about which many men are afraid to talk.
Please, for the love of all that is still decent, ACT! These women are our mothers, wives, significant others, nieces, daughters, granddaughters, etc. Knowing, as you do, of the horror stories surrounding Essure, can you honestly tell me that you would support the women in your lives having this device implanted? Could you do it without worrying that they just might be one of the ones who suffer?
FDA Response to Essure Letter:
“Thank you for reaching out.
We are aware that Bayer recently announced that it has voluntarily withdrawn the sale of Essure from certain countries for business reasons. As you know, Essure continues to remain a high priority issue for the Agency and we continue to review and consider all new information we receive.
After a significant review and analysis of available information, we continue to believe Essure is safe and effective for many women—but also that some women experience very serious and sometimes debilitating problems. Banning Essure would remove the device from the market for all patients—and would limit the options available to physicians and patients. The FDA will continue to consider regulatory options that appropriately balance benefits and risks for the Essure device.
Regarding the 522 study, the FDA approved the study plan on September 2, 2016. Since then, as the 522 website states, Bayer has begun its postmarket study. As of May 3, 2017, 60 sites had been selected for participation, 31 sites had submitted IRB applications, 24 sites had central IRB approval and 3 sites had been enrolled. Site and patient enrollment is a continuous process.
FDA takes reports of problems with Essure very seriously. The agency is actively evaluating postmarket experiences with this device, including analyzing reports of problems submitted to the FDA.
Post on vasectomy as alternative:
Jay W. Belle Isle
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