The Bleeding Edge: Documentary Review (Health Care/Medical Device)

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I saw this one popping up on Netflix every time I signed on, and eventually, my curiosity was piqued. I have a lot of experience with the health care system, both as a patient and as a provider, so I wanted to see what this documentary delved into.

This goes into the medical device industry, rather than the pharma aspect of health care, a topic that isn’t talked about nearly as much as the drugs that come along with health care. As far as money goes, the medical device industry leaves the pharma industry in the dust and it isn’t nearly as well understood by the public, myself included.

The first device they went into was Essure, a sterilization process that’s a nonsurgical alternative to tubal ligation as a permanent birth control method. It was described as a noninvasive, quick and painless procedure that was supposed to be less complicated than an incision. The recovery time was supposed to be minimal, and patients were assured that it was the best option. But, there were a number of complications that weren’t made public, and they were much more common than expected. Some of the patients serious bleeding problems that could have been life-threatening, some developed immunodeficiency disorders, others needed full hysterectomies. One of the women made a facebook page looking for other women who suffered bad side effects from the birth control – at first there were a few hundred, and then there were tens of thousands. All in all 33,000 women joined the facebook group, and they had a combined 9,000 hysterectomies. Together they researched the approval process for Essure and found out that it was approved based off of a very small number of women used in the study, those women from the study were not followed up with after 18 months, and to make matters worse, one of the people responsible for approving the drug had stock in the company.

Essure went through the Pre Market Approval process, it’s supposed to be the most stringent path to get approved for commercial use – but it’s still less strict than regulations for prescription drugs. Medical Device manufacturers are also sinking their claws into doctors with lower ethics who will promote their product regardless of its necessity or safety level. In 2016 Medical Device manufacturers gave out 2 billion dollars to doctors in the United States.

It also went into the Davinci Robot, the new surgical tool that you’ve probably seen commercials for or some video circulating online. The FDA was told that a huge amount of training, about 9 weeks, was going to be provided to the hospitals. However, once the FDA approved it, the company scaled back their training to just a few days, and then let the surgeons loose to go work on patients. The reason being, they couldn’t sell the machines because no one was willing to go through the training process. Doctors were talking about how they did one or two practice surgeries on pigs or cadavers and then started doing surgeries, but looking back they didn’t feel comfortable with the machinery until ~200 surgeries were under their belt. As a result, serious complications occur at a much higher rate using robotics than they do hands-on surgery. One of those that was covered in the documentary was called ‘vaginal cuff dehiscence’, where your intestines can come out of your vagina after a failed hysterectomy – it occurs 3-9 times more often with a robotic surgery over manual surgery.

Johnson and Johnson have faced over 300 million dollars in lawsuit damages over mesh gone wrong. Many women have bladder problems and involuntary urination post-birth. The mesh was supposed to help them control their bladder, but a number of problems arise with these procedures that weren’t made clear to those undergoing the surgery. A woman has been left unable to have sex with her husband because her mesh cuts her husband’s penis upon entry.

Bayer went so far as to forge documents, changing reports from “severe pain” to “no pain” under the logic that they couldn’t determine specifically that the pain was coming from the implanted birth control. They also changed “not happy” to “very satisfied” based on the fact that the women weren’t pregnant and therefore the device was ‘doing its job’. These women knew that their ratings were being changed, but were told this is all standard operating procedure for clinical trials.

Note: The laws on medical devices haven’t changed since 1976 and they just can’t cope with how we’re advancing today.

It was sad to watch doctors and nurses describe their stories where they unintentionally harmed their own patients with new and untested technology. These doctors aren’t going with new things with the intent to hurt people, and they trust the developers to have gone through the right processes to make sure they truly are safe. When that trust is broken it can be devastating for everyone involved. To the companies these people are just low statistics they find bothersome and want to silence so they can continue to make money. When you get into the stories of those statistics, lives are ruined, lives are lost, and people are left permanently harmed.

This was a very well done documentary, I learned a lot from it and I would recommend people watch this one. I have undergone many surgeries, and doctors are why I’m alive, but everyone should educate themselves on what procedures they are going to have performed on them before they go through with it. Ask questions, make sure your doctor has the proper experience if you’re going to have a robotic surgery.

Rating: 9.5/10



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