This is one of those moments that I wish jumping up and down and shouting, “Yes! About time!” was something more visibly sharable than by simply using words. And no, I’m not going to take a picture of myself attempting to jump up and down; no one but my chiropractor wants to see that! However, the sentiment is very much present as I get to write these incredible words: Essure is soon to be history in Finland!
This week Bayer announced that it will stop selling and distributing its “permanent” birth control device, Essure, in Finland as of June 25, 2017. The Big Pharma giant stated this decision is for “business reasons.”
We can’t argue with that, given that most women in Finland aren’t all that interested in having this unsafe device implanted in their bodies. According to Bayer’s announcement, “the demand for Essure in Finland has been low and is constantly falling and no change is expected.” That translates to: Bayer isn’t making any money off of Essure in Finland, so it’s bailing out of the market. Profits before patients.
Hey, if hitting Bayer in the bottom line is what it takes to get this evil device removed from the market, this is one time I’ll happily support profits before patients, because the end result is better for patients. This isn’t usually the case when corporations put their bottom lines before the safety and well-being of their customers.
The company stuck to its tired old “Essure is safe” story in the announcement, saying that, “Women for whom Essure is set can continue to use it safely and do not have to worry about it. The benefit-risk profile of Essure is still positive, based on a wide-ranging clinical development program and more than 10 years of experience worldwide.”
Right. If you believe that, I have a bridge I’d like to sell you.
For a product that supposedly has a positive benefit-risk profile, the damage Essure has caused cannot and should not be ignored. Essure, with its nickel-titanium coils and PET fibers is responsible for tens of thousands (that we know of) serious adverse reactions. The product has even caused loss of life, be it from complications or suicide.
As for this “wide-ranging clinical development program…” You mean the one that involved “forgetting” to submit approximately 17,000 adverse event reports? Is that the one that had such poor post-implantation follow up that the study is virtually useless? Is it the one in which Conceptus’ (Essure’s original manufacturer) CEO, Steven Bacich, acknowledged the efforts of Cindy Domecus as being instrumental in Essure’s PMA approval? Note: Ms. Domecus was on the Obstetrics and Gynecology Device Panel of the Medical Device Advisory Committee for the FDA during Essure’s PMA review, while she also worked at and owned stock in Conceptus.
That “wide-ranging clinical development program? So, how about that bridge?
As part of the announcement regarding Finland, Bayer also said that it “will continue to be responsible for product-related issues and will report any suspected adverse reactions to the authority of Essure.” Somehow, I cannot bring myself to believe that, no matter how hard I try.
Bayer has done nothing but duck responsibility for “product-related issues” in the U.S., and has a history of failing to report adverse events involving Essure. The company can’t even follow the FDA’s request for further study, as described in the February 29, 2016 media brief issued by the Agency. In the brief, Dr. William Maisel, Deputy Director for Science and Chief Scientist at FDA’s Center for Devices and Radiological Health, answered a question regarding Bayer’s fulfillment of the Agency’s request.
“So Bayer is – we expect Bayer to submit a study protocol to us within 30 days. By law they must begin their clinical trials within 15 months. And failure to do so could result in the agency taking action such as issuing a warning letter and declaring their device misbranded. We have taken those actions in the past and we will do so in the future if Bayer does not meet its requirements.” [Emphasis added.]
That 15-month time period within which Bayer was directed to begin the new clinical trials lapsed at the end of May. And Bayer expects us to trust that it will report adverse events? Seriously, it’s a mighty fine bridge. If you buy it, you’ll be the envy of all your friends.
There is no doubt that Bayer’s decision to stop selling Essure in Finland is a victory for women’s health. Sources state that the Netherlands will not be far behind in getting rid of Essure and Brazil has already issued a ban.
So, Dr. Maisel, I’d really like to see a copy of that warning letter.
Perhaps this, along with litigation across the country, will be enough to finally get rid of Essure in the U.S.
When that day comes, you just might be able to convince me to take that picture of me jumping for joy.