This video is a small sampling of a subset of patients who were implanted with Bayer’s Essure “permanent” birth control device. The known subset totals 24,000 women and counting. Those women who haven’t gone public or who may not even know that Essure is the source of their problems, aren’t included in that number.
This video is a small sampling of a subset of patients who were implanted with Bayer’s Essure “permanent” birth control device. The known subset totals 24,000 women and counting. Those women who haven’t gone public or who may not even know that Essure is the source of their problems, aren’t included in that number. Most media outlets – and even Bayer itself – claim that there are currently 750,000 total Essure patients. This is an important number for a reason I’ll explain shortly. It’s time for Bayer and the FDA to wake up! How many Essure victims is enough?
I’ve yet to be able to find clear documentation (if such even exists) that says something to the effect of “Product A is considered unsafe when X% the patient population presents with serious adverse effects post-FDA approval.” Likely, there is no hard and fast number, but one would reasonably expect some type of formula.
Earlier, I said the claimed number of 750,000 Essure patients is important. Here’s why:
- Let’s say, for sake of argument, that a “magic” number does exist and that any adverse effects reported beyond that number could end up forcing a product off the market.
- A basic formula for determining whether a product is safe or not would be number of reported adverse effects divided by total number of patient population equals the product’s score as a percent.
- For our example, let’s assume that the number of known Essure victims is 24,000 and that the total patient population is 750,000.
- Using our basic formula, Essure would have a score of 3.2%.
- Let’s say the magic number is 5%. By this basic formula, Essure would be considered safe and the 24,000 victims would be acceptable.
However, what many don’t know is that the total population of Essure patients is not 750,000. It’s significantly smaller, estimated by some as closer to 625,000. In reality, that 750,000 figure is the number of Essure kits sold.
I’ve seen forum comments on this issue, too. One stated that when her daughter had Essure implanted, the doctor actually ended up opening three kits. Each kit contains two Essure coils, one for each fallopian tube. I watch a video this afternoon in which the doctor was only able to implant one Essure coil due to complications. The patient had to return a month later to have the second coil implanted. That means two kits were used.
Assuming that the 625,000 patient population figure is accurate, let’s redo the math:
24,000 adverse effects divided by 625,000 patients equals 3.84%.
We’re still not at that arbitrarily chosen 5%, but we’re a lot closer. And, research indicates that there are several unreported adverse effects for every one that is reported. If, for sake of argument, that “several” equates to “one,” that means the number of adversely effected patients is closer to 48,000. Let’s do the math again:
48,000 adverse effects divided by 625,000 patients equals 7.68%.
While the studies that attempt to put a real value on “several” estimate that the ratio of known to unknown adverse effects is much greater than my hypothetical 1:1, there isn’t an exact number.
The point is this: even if there is such a magic number of adversely effected patients beyond which a product is automatically deemed unsafe, misrepresentation of the actual number of patient versus the number of product sold reduces the product’s “safety score.”
In this age of being able to track everything down to what products I look for online so that retailers can flood my Facebook page with items in which I may be interested (within less than an hour, I might add!), I find it hard to believe that we can’t track actual numbers of Essure kits implanted versus sold.
Furthermore, if doctors spent more time listening to patients instead of watching the clock for the next one or dismissing symptoms as “all in their heads,” we might actually get a better grasp of the true number of adversely effected patients. The FDA relies upon its reporting system, MAUDE, but that relies upon patients knowing it exists, as well as doctors and corporations using it to report possible adverse effects.
Here is the link for reporting adverse effects.
Please, if you believe that Essure is causing your problems, click the link and report it. We cannot rely on Bayer to provide the FDA with data reported directly to the company (even though federal law requires it), nor can we count on our doctors to do it. This goes for any medical device or drug, but given the unacceptably slow response of the FDA to the Essure crisis, it’s especially important for Essure victims.