I get way to invested in documentaries. I love them because they make real events, dramatic and spill the tea on things most people don’t know about. After watching “The Bleeding Edge” on Netflix, I was truly shook and concerned about what’s in my girlies boxes.
I was so concerned I reached out to Mama Dutches, my sister, mom and aunt to ask them all the same question, “Hi, random question, but do you have vaginal mesh or a metal birth control coil in your vagina”? They all responded the same, “WHAT THE FUCK? Why are you asking me that you sicko”. Woahhh nelly I was just concerned because of this documentary I watched, I ain’t trying to dirty talk, slow your role.
I’m asking out of a place of concern! Daddy truly cares about his girlies way more then the FDA does. This documentary is about how the FDA approval process for new medical devices that GO IN OUR BODIES, is a joke. They truly only care about making medical companies even richer. In their eyes the patients are disposable. If a couple hundred die, the settlements(if you even get one) are not even .2% of their profits.
The main devices this documentary focuses the most on are the Vaginal Mesh, a permanent birth control called Essure, a robotic surgery device called the Da Vinci and a metal on metal hip replacement. All of these have something in common, they used the 501(k) clearance instead of premarket approval. 501(k) is for devices that are “substantially equivalent” to a device already cleared by the FDA or marketed before 1976. This is legit a scam, it allows companies to basically find a loop hole to getting their products tested by the FDA. This allows them to do most of the clinical testing. We are supposed to believe these companies actually care about us and not their profits, major eye roll.
Pre-Market approval is a higher standard and the actual human data is required to approve it. Under 501 they could legit test it on just animals and say okay it works YAYA!! Is that a sick joke? This is how shitty products featured in this documentary got approved. Do these companies understand that these are legit LIVES they are messing with? I bet the CEO’s of Bayer and Johnson & Johnson, made sure none of those devices are in their moms box, but its cool for Carol to use!
Essure is a form of birth control that is basically a medical coil placed in a girls uterus. It irritates the tube to make it close off so eggs don’t come into contact with sperm. SOUND AMAZING RIGHT? Well no. This product was tested on only a few hundred patients and because of 501 it was cleared to market. This documentary legit has footage of the FDA meeting approving it and its a joke. Bayer who made it, had very little information on the negative reactions to the device and the FDA even joked about having to come back years later because of too many negative reactions to it, I wanted to bitch slap them all.
The problem with this device is the fact that there is no real training or research around it. Doctors are basically guessing when they place it up there. When they miss or lose it, Bayer reps told them to add another one, yeah because its normally to have a coil floating around your uterus. One lady deadass had 6 of these in her, 6!!! Also, when ladies wanted it out, there is legit no real way to get it out.
They have to pull on it and hope for the best. This caused them to break apart and become lost in the uterus, causing their immune system to fight back and legit having horrible results. THOUSANDS of woman had to get hysterectomies because of this thing. Over 800 mothers have gotten pregnant and their babies had died because of this thing, but the FDA and Bayer say that’s fake news, girl please. In 2017 alone over 12,000 negative reactions to Essure were reported to the FDA.
What makes this even more sicking is the EU asked Bayer for more info on this device and instead of giving it to them, they pulled it from the market but continued to sell it in America, again WHAT THE FUCK. The other product featured is vaginal mesh that legit makes having sex with lady sound like a horror film. Basically, this device is used to put parts of the body back into place after having a baby. A woman used it to put her bladder back in place because she was constantly peeing her pants. Well one night her mans went to have sex and the mesh moved and cut his dick, I have PTSD from hearing that .
So why would any doctor allow their patients to use this device? Well because this is America baby and bribes are an everyday thing. Medical companies are paying doctors for “consulting fees or fellowships”. This is a loophole to pay doctors to be these companies bitches. In 2016 alone, over $2 billion was giving to doctors by the medical industries. This allows the medical industry to use 501 to conduct their own studies, then pay doctors to say they agree with it. How gross! I called my doctor to ask if she a bitch of the medical industry but she told me to leave her alone, rude! Imma research her ass.
Also, the problem lies with the lobbying industries. Lobby is legit a joke, its a way to secretly bride politicians into doing what you want. In 2017 alone, over $64 million was spent by the medical industry to influence Washington to water down medical devices approval process. Use that money to cure cancer, da fuq.
The FDA should be protecting us but really its just a revolving door for medical CEO’s to “retire” from their million dollar jobs to “help America”. But really they just work for a few years, then quit and become a consultant for the medical industries, aka tell them how to get around all the processes, they basically spies!! Legit almost all the heads of the FDA went back to work for them after. One of them, husband was a hedge fund CEO who invested in medical companies while she was commissioner, she defiantly not invited to bridge night.
If you think Papi Trump is gonna change this you need to be smacked. He appointed Dr. Scott Gottlieb, a ugly ass mofo who was an consultant for medical companies and worked for a venture capitalist firm that specializes in start up medical equipment. His company New Enterprise Associates helped fund, are you ready for it, fucking ESSURE! Elizabeth Warren said during his appointment hearing “you oppose the FDA basic safety mission” and girl wasn’t lying.
When this was discovered he announced he would recuse himself from decision regarding companies he was involved with, wow so great right? No, this is only for 2 years, someone give me this dumb asses number PLEASE! I just wanna chat. His first act on the job was to hire a lawyer who’s previous job was to represent Bayer against patients harmed by medical devices. And we’re supposed to believe he’s there to protect us, girl bye! The head of the largest medical lobbying firm, Advamed said “where we were 5 years ago with the FDA, compared to now with you is like night & day”, he ain’t playing! Our bodies are becoming the wild wild west, enter at your own risk.
These are legit devices going in peoples bodies, would you give it to your mom or wife? I think not, assholes. Something like this could happen to one of my girls and then you will be story. Nothings worst than a daddy pissed off, I never sleep, my mission will be to bring these companies and the pricks behind them down.
The AMAZING women who brought attention to this are my new heroes. I’m obsessed with them! They went on a media blitz and made Facebook pages everywhere, this was a problem nationwide that no one was talking about. These companies called them lairs, said it was all in their head. Yeah they making this all up for attention, are you that dense?
Because of this film, Bayer said they would stop selling Essure by the end of 2018. Not right away but by the end of the year so they can sell off the rest of their supply, let’s be for real. A NETFLIX documentary had to be made in-order to make something happened, that’s shows how sick this world is. Johnson & Johnson is being sued by over 65,000 mesh patients but no money can saved the damage done to them & their mans dicks.
If a product is new and your doctor rants and raves about it, RESEARCH IT FIRST! See if it was approved by 501(k) or Pre-market, that search alone could save your life. Also check Openpaymentsdata.cms.gov to see if your doctor is being paid by the medical companies, let’s put these bitches on blast!
Xoxo I may not enjoy it but I will DIE protecting my girlies box
Sir Dutches 
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