Just two years ago, I had a totally different perspective on how the FDA works and the amount of testing that goes into ensuring that drugs and medical devices are safe. I trusted my doctor to give me the prescription or advice that would best address my problems because I’m not the one who went to medical school.
Now don’t get me wrong: I’m not an extremist who thinks all drugs are bad and all doctors are too busy to care. (Living with chronic pain and infertility, I’ve had my share of the good and bad of the medical world.)
What I do believe is that as individuals, we have to educate ourselves to ensure that we’re getting the optimal treatments possible – and part of that is weighing the risks and benefits to the medications we take and the procedures we may have.
One example is that of transvaginal mesh (which is also called TVM or “pelvic mesh”). If you have TVM, if you’re considering having TVM, or if you want to learn more about the indiscrepancies of the FDA and big pharmaceutical companies, keep reading.
Here are 3 crazy facts about TVM that you should know.
1. NO TVM implant was ever tested before being put into millions of women due to the FDA’s 501(k) clearance process.
What this means is that if a medical device was already tested and approved by the FDA, then a similar product can enter the market without having an expensive and long testing period. In this particular instance, the ProteGen sling was approved by the FDA and was the basis for future products. However, the Protegen sling was recalled in 1999 due to complications.
So basically dozens of types of pelvic meshes were fast-tracked through the FDA and are being used in the U.S. based on a dangerous product that was pulled from the market! Even the Netflix documentary, “The Bleeding Edge”, calls out the makers of TVM and sites the huge profits big pharma is making off of the trust of millions of women.
2. There’s a safer way to relieve pelvic organ prolapse (POP).
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POP occurs when the vaginal walls weaken and organs start to droop into the vaginal. Surgical mesh is commonly used to support these organs from slipping. However, mesh can erode and migrate causing sharp shards of plastic to move in the body which can cut or slice organs and tissue.
There are other procedures (such as the Burch procedure that uses your own ligaments to support your organs) and medical devices (such as pessaries) that have had fewer reported complications as compared to TVM.
Please note that every person is different, so discuss your options with your doctor to determine which choice is best for your unique circumstance.
3. TVM has been banned in Australia and New Zealand.
It has also been halted in Ireland and the UK until medical professional can prove that the benefits outweigh the risks. Unfortunately, TVM is still legal in the US! Why is it banned in other countries but okay for American women?!?!
If you had to have TVM revision surgery, contact Periscope Group today. We want to hear your story! TVM was never properly tested and has harmed tens of thousands of women. It’s time for your voice to be heard.
We can’t let Big Pharma get away with this!
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