Innovation and “The Bleeding Edge”

There’s a documentary that’s been added to the Netflix library that I think everyone should watch called “The Bleeding Edge.” Overall, the topic is supposed to be about medical devices. But talk about intersectionality! Unfortunately, I think that women are going to be drawn to this movie more than men – because we are experimented on and dismissed much more than men and the movie makes it much more evident.

Every once in a while, we get to see a little snippet of a CEO standing on a stage proclaiming the audience of marketers and/or health care professionals “innovators” or “disruptors.” I really struggle with these labels. I see them thrown around often. What do they mean, exactly?

Nothing has really changed drastically here in the U.S. with the delivery of healthcare. We are still beholden to insurance in the traditional sense, and pharmaceutical companies, hospitals and medical device companies drive pricing, which is all over the place; nothing is uniform. Right now, only those with expendable income can stray from the model. Delving a little deeper, not every state is set up for people who are at or slightly above poverty; instead, the state laws are designed to punish them for lack of income and lack of healthcare, while simultaneously penalizing them for not taking better care of their health.

“The Bleeding Edge” covers such medical implants as hip replacement systems and the Essure coils, which are discussed in detail. I can relate to this topic on a few levels. First, all ten of the shunts that I had implanted between July 2011 and May 2015 failed. I went to a hydrocephalus conference in 2016 and was able to attend a panel with all of the major device manufacturers, and got the mic for a question. I detailed issues with scar tissue growing into the programmable part of the shunt which made the dial get stuck wide open, causing excruciating pain (and if any of you reading this have had a leak, imagine the symptoms for a year where you feel like you are being beaten by a tire iron every time you raise your head). The manufacturers insisted this was “impossible.” I told them they couldn’t say that to my face, because I was living proof, and one of their reps was in the exam room with me to witness it.

Any time, and I mean any time a device company says something isn’t possible right out of the gate, you know something is up. As outlined in “The Bleeding Edge,” women who had Essure implanted were only reported on for the first 12 months – and even for those women, their answers were altered so the outcomes were positive. As far as my shunts go, I didn’t know before my first surgery that all shunts have a 40% failure rate within the first year. I still haven’t seen that published anywhere. I wouldn’t have known that if I hadn’t attended the bi-yearly hydrocephalus conference in 2016 and heard it from one researcher (and only one researcher).

My second connection is that I actually seriously considered the Essure implant. A friend had them implanted in her Fallopian tubes and seemed to suffer few side effects. I wanted to stop taking birth control pills but didn’t want other hormones, and thought maybe the coils would be a viable permanent solution. I actually developed tumors in my uterus and had to have a hysterectomy, otherwise I may have completed that process. I’m breathing a sigh of relief that I didn’t after seeing this film. I didn’t realize the scope and breadth of complications – but more importantly, now that I know I overproduce scar tissue internally because of MCAS, I could have been in terrible trouble (besides what is happening now). I don’t know what I would do if I had to deal with that in addition to the scar tissue I already have growing around my intestines.

Another alarming process pointed out in the film is that devices are grandfathered in simply because they are similar to other devices that have been created. It doesn’t matter if the previous devices were defective. It only matters that the devices existed.

There are many moments in the film that made my blood pressure go up immediately. For instance, some fat ass doctor watching protesters who received the Essure implants say that they made up their complications. He is misogyny personified. And when a rep whose identity is disguised tells a story about a doctor who admits that the rep’s product is superior but he doesn’t get enough financial incentives so he’s going to promote a competitor’s product, I’m tempted to throat punch someone. Or how about when the filmmakers point out the different companies the former heads of FDA went to work for after they were done in the public sector so they could help get the products passed through the FDA for bigger profits with no thought to safety or effectiveness?

What would true innovation or disruption be? Let’s disrupt misogyny. Let’s disrupt hiring from the public sector into the private sector and vice versa so we can eliminate cronyism and sole emphasis on huge profit margins and replace those with successful medical devices and prescriptions. Let’s build a truthful healthcare system and test products before they are put into our bodies. (Don’t say it can’t be done. Other countries already do it.) Let’s build a healthcare system that is not based on employment or lack of employment. Let’s call it something other than “innovation” and “disruption.”

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