Wake Up! How Many Essure Victims is Enough?
Wake Up! How Many Essure Victims is Enough?
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.
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.
About Jay W. Belle Isle
Before becoming LegalReader's Editor-in-Chief, Jay W. Belle Isle worked as a freelance copywriter with clients on four continents. Jay has a degree in Business Administration from Cleary University and a Juris Doctor from Thomas M. Cooley Law School. Jay has also worked as a contracts administrator for a DOD contractor specializing in vehicle armor.