In a (since-removed without explanation) post on the FDA’s website, it was announced today that the FDA spent the last four month poring over thousands of women’s adverse event reports related to Essure, (presumably?) investigated testimony from September’s hearing from multiple clinical trial participants who say their reports were falsified in a number of different ways by Essure’s manufacturer (who was in charge of the clinical trials) and being publicly warned by Congressman Fitzpatrick that the data about fetal death related to Essure was way off-303 deaths instead of the five previously reported...after digesting ALL of the above information, the FDA decided to require doctors and patients to fill out a checklist to see if future women being implanted with Essure have a higher risk of side effects, they have requested more warning label information from the manufacturer, and they are requiring the manufacturer, Bayer, to conduct a safety study that includes the adverse events reported to the FDA.
Why, if there are multiple women saying that Essure’s manufacturer falsified their own clinical trial data, are we trusting them to provide valid information to the FDA about the tens of thousands of women who are suffering? Why are they allowing a product who has harmed so many to remain on the market? Why are they upholding Bayer’s premarket approval they received for Essure when the clinical trial data may have been falsified in the first place? What about people like me, who had Essure implanted back when the ONLY possible side effects listed were three days of mild cramping?
Also, why did the FDA subsequently remove their post?
I am disgusted, heartbroken that I cannot recoup some measure of what my daily, excruciating pain has taken from me and my children. I’m appalled that I am unable to work but am not compensated for the very real medical problems brought on by a device that never should have been approved. And, again, if a product had caused 27,000 (yes, we’re up to 27,000 now) men to lose their penises and testicles, that product would be pulled, the men compensated and they would not have to plead their case on Facebook, blogs and the local news. I am furious.
A link (now resurrected without comment) to the FDA’s announcement:
A link to Rep. Fitzpatrick’s response:
A link to the response from Essure Problems Group’s Admins: