The Bleeding Edge: Are Medical Devices Killing Us? | AMA 08

[@julionovoa901]

Good morning Dr. Zdogg, My name is Dr. Novoa. I was a featured commentator in THE BLEEDING EDGE documentary. I greatly appreciate the fact that you took the time to speak about the documentary and explained many of the important issues and concerns we have with medical devices. For the past 4 years, I have been helping women educate themselves regarding the Essure and explain how such as device got on the market in the first place. Overall, I believe your comments were positive and supportive, but many women affected by Essure feel that your comments about the documentary being "inflammatory" missed the mark and downplayed the problems with Essure. I have encouraged doctors in your specialty, Emergency Medicine, to look out for patients with Essure complications because few doctors, including those certified by Bayer to place the Essure, understand or know how to place or remove the device. The problem with Essure is not solely how Bayer got the device on the market, but how inexperienced doctors with a financial incentive began placing the device incorrectly and then ignored the signs and symptoms and complications associated with Essure. Even after the FDA placed a BLACK BOX WARNING on the Essure, doctors were either not informing or misinforming patients about the serious problems with Essure. The same situation has been happening for years with the vaginal mesh which is associated with 10x the number of injured women and billions of dollars in lawsuits. As a cosmetic OBGYN, I am also well aware of the problems with devices like the Mona Lisa and I am happy that you warned your friend about continuing to use it, especially if it was marketed to her as a "vaginal rejuvenation" device. I could go on and on about the problems we are seeing in the field of obstetrics and gynecology and medical devices. I thank you for posting your opinion about the Essure and Mona Lisa, and I hope that you will take some more time to see that just how bad the problem with the Essure has become and how many women are suffering and will continue to suffer with complications from the Essure and the inappropriate management of its complications from doctors trusted by patients to help rather than harm them. Sincerely, Dr. Julio Cesar Novoa, MD (Cosmetic OBGYN, El Paso,Texas)

[@karinvanrijn7441]

Thank you for taking the Essure problems serieus.

[@ObsidianStray]

I didn't get the impression from the documentary that they were making out medical devices to be bad. I got the impression that they were criticizing lax FDA regulations, caused in part by allowing conflicts of interest to exist between the FDA and private medical companies.

[@jonathonhazelton7688]

They were pushing that very hard, and also showing the harm from these devices to make the point that the system is failing.

[@SuchingYan]

@@jonathonhazelton7688 then why did they show what that hip replacement doctor said about plastic device? is plastic hip replacement device not a medical device?

[@All_Im_Saying_Is]

Here’s my little bit: I truly believe that sarcastically using the phrase “the sky is falling” harshly minimizes the impact it had on the people who actually experienced those side effects-myself included. While I understand the objective as a whole in this video, it fucking sucks to hear. Just on August 1st (last week) I had a laparoscopic bilateral salpingectomy to remove my Essure devices. They took away 5 years of my life...and almost caused me to end it. I didn’t want to live anymore and I had no idea why. Suicidal thoughts, migraines, severe anxiety, unusually heavy menstrual cycles, sleep deprivation, overwhelming exhaustion on a daily basis, pelvic pain, autoimmune symptoms...ALL of that could’ve been prevented but money ultimately made that decision. That Facebook group mentioned in the documentary has over 42K people in it. That’s an INSANE number. And quite frankly, if it wasn’t for The Bleeding Edge and that group then I’d have absolutely no idea where any of that was coming from...it saved my life. So yes, please do your research, but at least it was highlighted that you unfortunately have to question your doctors motives.

[@nightsky4132]

Two points. Healthcare has become too much about money-making. And: caring about people and their health and well-being is SECONDARY to profit. It's depressing.

[@nightsky4132]

My two points are redundant. But true.

[@graham6132]

Would you rather have someone who scores 1600 on the SAT become a brain surgeon or a wall street banker? If you take the “money-making” out of healthcare, you take all the incentives that attract the most talented people. Nobody is going to become a surgeon to make 60k a year when they could easily make 7 figures as financial analyst on Wall Street.

[@joanfrazier5343]

I never knew it wasn't mandatory for doctors to report complications. You think in 2018 we would be more proactive. Thanks for the information.

[@danyellerobinson5940]

They only have to report if they believe the device is responsible. If no one has reported, then how would a doctor know it was related? BTW - there is now a new process for patients to report adverse reactions to the FDA.

[@lynnwood7825]

Maybe you also never knew that according to the FDA's own website "In most cases, a company (manufacturer, distributor, or other responsible party) recalls a medical device on its own (voluntarily). When a company learns that it has a product that violates FDA law, it does two things: • Initiates a recall (through correction or removal). • Notifies the FDA."

[@ChristineExhaleRelax]

Breast implants almost killed me, had the explant 7 months ago, still recovering. Suffered from unexplained autoimmune conditions and multiple food and chemical sensitivities, a mild viral infection would have me end up in the emergency department as my immune system was not able to deal with it. I think some of the damages are unfortunately chronic. I am so happy that the truth is finally coming out, some medical devices are obviously solely for money-making purposes, at the cost of our lives.

[@Saknika]

I'm totally late to this party, but I feel this on a personal level. Had an OBGYN pushing an IUD on me to basically get me out of her office (I've had an irregular cycle my whole life and no one could tell me why, just told me to take BC for it). It honestly sounded too good to be true, especially when I asked what the risks and side-effects could be and she said "none". I kid you not, that was her response. That it was 100% safe. She was ready to do it right then and there. I told her no thanks, I wanted some time to think on it. Went home, looked it up, found lawsuits of women who had horrible, horrible complications from the brand this OBGYN was pushing. Some of these women, in the more severe cases, had needed hysterectomies. Scary stuff! But the #1 thing that caught my eye was there was no gray area. Women either loved or hated it. So ultimately, I turned it down, no regrets. I'm just glad I had the presence of mind to not be effectively pressured into something by someone I should be able to trust. I saw her one final time for a regular exam, and after this incident and a couple others, I fired her as my OBGYN. It was clear she didn't have my best interests in mind, we were not a good doctor/patient combo. So yeah, definitely question everything, do your own research if possible, get second opinions, and if necessary, fire your doctor.

[@kaze_cat]

I had C7 birth control device implanted by my GYN in the late ‘70s. Sometime later I came down with excruciating abdominal pains that doubled me over while I was working as a grocery checker. Was taken to emergency at the hospital where they diagnosed me with a uterus infection, caused by the IUD. I had it removed then. I had zero idea that that was the cause, or that it could cause complications. That was prior to the internet. Today, there is so much info out there and we can research these devices on the net before we ultimately make a decision.

[@cosmogal627]

I had mesh for complete pelvic floor failure. I.have had nothing but issues since. Its horrible. My life has change completely. So many side effects!!!

[@toriclark5160]

I'm glad that you made a video about this. I came across The Bleeding Edge and watched it before hearing any of the hype. It was disturbing. A few years ago I had wanted to get my tubes tied and my doctor explained the Essure procedure to me. I took a year to think about it, then went to another GYN asking to get my tubes tied again. She explained the procedure, and I remember they both tried to sell me on the "minimal recovery" aspect of Essure versus the up to 6 week recovery from tubal ligation. I don't fault them, I'm sure they honestly thought it was a better/safer/less invasive option based on the information provided to them at the time. I almost did it, but I hated the idea of 1) metal being implanted in my body, and 2) it only works because it causes inflammation & scar tissue to form, with the hopes of clogging off the fallopian tubes, which still isn't 100% effective. I'm an RN, and while I know no form of birth control is 100% effective, I looked at my GYN and said something to the effect of, "F*ck that sh*t, I'll take the tubal and 6 week recovery over inducing inflammation and scar tissue please." My thinking in this may be a little skewed, but my thoughts kept going back to PID and endometriosis. I know many women who suffer from inflammation and scar tissue in and around their uterus, fallopian tubes, and ovaries, and would do anything to be cured of it. Yet, here was this "innovative" new form of birth control that advertised it. (My guess is some dude in a lab came up with it. No female physician in her right mind would have created this.🤣) Here's the thing. I could have easily been one of those women in the documentary. And while I loved your video and appreciate what you had to say on the topic, if I were in constant pain and having complications daily due to a product like Essure (that maybe wouldn't have made it to the market to begin with if it had been more throughly researched), I might be inclined to think "the sky is falling and everything is terrible" too. I can accept that medicine is very trial and error. That's the nature and history of the profession. Though, the whole point of ethics committees and the FDA is to ensure safety measures are in place to prevent harm (when possible and within reason). Yet we repeatedly see manufacturers protect their bottom line over patient outcomes and there's rarely any backlash for it. This documentary really made me rethink the word "innovation" as well. It's not as bright and sparkly, or even necessarily good in my mind anymore. 😔

[@betsyhampton8361]

I'm glad you didn't get Essure.

[@amyvalandingham3170]

Thank you for your support. I wish i had taken more time or had the correct info 13 yrs ago before agreeing to Essure

[@alexandraurbanski5999]

I am a former Essure patient. Also a member of the Essure problems webpage. I can tell you for a fact that everything those ladies had to say on the matter is 1000% correct. I've been to rallies with these women, protesting even outside Bayer HQ in Whippany, NJ. The facts are there, the data that they speak of is real. Glad you didn't get the device though...I had to have a total hysterectomy to remove it after 3 years of unexplained hell...at age 30. I can tell you that a week after my surgery it's like all the problems went away. The stories are real...and thanks to us not shutting the hell up about them, Bayer took it off the market, right before the premiere of the Bleeding Edge on Netflix due to "poor sales"...how interestingly convenient...

[@pinkiegirl1947]

@@alexandraurbanski5999 I'm glad you got better, but what a mess for you to have gone through all that! I just ran across this eye-opening documentary tonight on Netflix and was glad to have seen it since I know several people who have had hip and knee replacements and want to let them know about the risk of cobalt toxicity. However, I was interested to learn that the efforts of the Essure group in both the US and several other countries, got the product taken off the market much earlier than in the US. The United States is great, but there are many here in charge who are kind of dumb when it comes to making changes that save lives through some of this 'regulation' that a lot of people want to curtail!

[@brittniannie]

Thanks for comming out and saying this I've had esure for 9 years this September and I'm seeing many complications now some docs wont even as much as listen to me. Life sucks to put it bluntly I only wish every time I went in for prenatal care that i didn't have to watch that add for esure it's like it was repeated to me and brainwashed me like this is the best option for me.

[@danyeldoyle9685]

Thank you for doing this. I’m one of the women who will forever be charged by essure. I’ve had 2 surgery’s and countless tests to fix me. This is year 4 and I’m still suffering. Even with the lawsuit they still aren’t taking accountability. I also think the payout it’s enough for all that we have gone through.

[@libbyhicks7549]

I also think that this documentary wasn't especially for people who are interested in this particular device, it was an expose on how the pharma big med industrial complex reacts and handles products that are dangerous to some percentage of the people it is marketed to.

[@BetrayaloftheBody]

Actual truth that happened to me with da vinci surgery was the robot lacerated my ureter undetected. Went undetected until my kidney ruptured. That led to me developing a seizure disorder that is resistant to medication. 9 years later I'm still having 40 seizures a day, pain during sex, and bladder problems, let alone the lack of kidney function from my Frankenstein kidney left behind.

[@ClayMastah344]

What procedure did you have? Laproscopy?

[@BetrayaloftheBody]

@@ClayMastah344 this particular time was to remove a cancerous tumor off my fallopian tube and remove endometriosis tissue

[@canadiankin]

Terrible!

[@beebeebird2878]

I’m an mri tech, I am constantly surprised by patients who don’t know or don’t understand what their devices safety issues are. I had a patient several days ago who was told the his device was mri safe. I looked it up, spoke to the company, and while the device was safe, the leads were not. It turned out that during implantation it was discovered that the mri safe leads were not long enough. So the surgeon chose to use the other leads. Which negated the reason for using the mri safe device. Unfortunately most of the mri “safe” devices come with conditions that the mri facility has to meet to make them safe.

[@skyhoward2050]

Speaking of shit thats done to women without any actual concern for future wellbeing, i'd love to see a show about womens health! Maybe a gynocologist or endocrinologist discussing the amount of problems that go undiagnosed because doctors write things off as "pms" and "normal period problems" and leave women suffering for years or decades without diagnosis of pcos, endometriosis, pmdd, etc. Also the lack of treatment options and lack of studies done to try to better understand womens health problems, properly diagnosing them, etc. I'm sure you could find a fantastic guest and I'd love to hear your point of view on this now that its actually being brought up more and taken more seriously instead of just letting women suffer. Having to advocate for your own health and try to convince doctors that something is really wrong and no its not just PMS is something that tens of thousands of women deal with every year and it really hasnt gotten much better with time. Hope to see a womens health show or 2 in the future!!

[@brittanyhernandez191]

Thank you for this video. Please consider when voting, representatives who will change the regulations around medical devices. It's usually presented as a doctor vs patient issue when in reality both are getting a disservice by the current system.

[@RobertSzasz]

Horrible horrible medical devices. Pacers, defribs, pins, plates, external fixation, ecmo..... Though I'm sure I speak for every single medical device developer or manufacturer in saying publicly funded testing would be great. And it would drive development costs down through the floor (and should drive end costs down). Edit: but to agree with your final point, post approval monitoring needs to be more rigorous. Some of that is on the companies, some on the doctors who do the procedures, and some of it is on lack of education/training about how and when reporting should be done.

[@catherinebell9019]

But publicly funded testing/research would cost money, which would likely be funded by tax dollars. And we live in a society that is very poorly educated, on average. So you have a population who believe that 'Pharma and medical device companies doing their own research is CORRUPT!' but who also don't want the increased taxes and regulation that would come with publicly funded research. Again, I agree that publicly funded medical research should be the norm, but given the cost of medical research, especially drug trials, public opinion, and essentially the structure of our entire healthcare system, I think it'll be a pipe dream for quite a long time.

[@danyellerobinson5940]

you miss some big differences in device approvals/clearances. You also failed to understand the black box warning issued by the FDA and the bigger pictyure of what's happening in the device industry as a whole. Poor reporting.

[@sajindal1]

I think “a big deal” is an understatement for the victims of these fucked up devices. They have ruined lives.

[@craftgrrl14]

I have a Medtronic Enterra II Gastric Stimulator Implant for my Gastroparesis. It is classified as a "Humanitarian Device" since there is little data on how it actually works. Hard for me to tell if it is helping or not. I got a J tube placed at the same time. The J tube definitely helps, I have no idea if the stimulator is doing much or not. I was underweight, dehydrated, and desperate for something to help where all other medications and procedures had failed. I am doing better now. I have put on about thirty pounds of weight and no longer fit into the same clothes I had been wearing since early high school! Tube feeds definitely help me and I hope the stimulator is doing some good too. otherwise I have this hunk of metal under my skin for no reason.

[@shulzinger]

Doctors have to read trials data before they use the device

[@sarahcrain8083]

Good morning ZdoggMD My late mother had a St. Jude's Merlin Pace maker. It was setup to drive the bottom of her heart at a steady 80 to 81 BPM. When all other treatment to manage her AFib failed. It made all the difference in her quality of life. In early 2011 my husband's left knee was replaced with a artificial joint made by Stryker. He is a larger than average man. He has done well. His surgeon retired and discussing future replacement of right knee. Every surgeon we have meet since left knee TKR, they use other brands of artificial joints. Some of which I have researched and found to be inferior to Stryker. Bottom line. It is important to trust that your surgeon has done their own independent research of medical devices, used in their field of expertize. To conduct your own research when possible. Don't be afraid to ask your doctor questions. Like, how many of these devices have you surgically implanted? What has been the success rate of those devices in your practice? What other brands of this particular device, if any, have you used? Why do you think this brand is best vs. the others? One question I find that can make most doctors pause for a moment before shooting off a answer: If this was you or your loved one, knowing what you have learned by experience, would you recommend the use of this product for yourself or them?

[@pinkiegirl1947]

It's good that your mother and husband had successful experiences with their devices. I don't think the point of the video was to say that all devices are bad. The take home message is that many of the devices were approved without any long term clinical trials to test them on people over a long period of time. And the trials that were conducted were most generally done by the manufacture who had vested interest in the product looking good. The manufacturers of the devices were able to push them though for FDA approval because they were similar to other devices that had already been approved...and not because there were trials with current patients to study them beforehand. That unfortunately became dangerous for many hundreds of patients who developed dangerous side effects...particularly for the hip replacement patients who developed high levels of cobalt in their blood stream as the implants deteriorated and leaked the cobalt into the body - and then had to deal with the side effects of it's toxicity in the body, like heart problems, neurological problems and dementia to name just a few. The side - effects were those which one not normally associate with a hip replacement. One's doctor/surgeon may have great skills in the OR, but if the device he or she is implanting is going to harm you down the road, even unknowingly, as happened in the cases in the documentary, it is, as you said, important to do your own research on all things that are going to be put into your body!

[@libbyhicks7549]

Yeah, lucky you, but there are plenty of other endings to the same story. The point isn't that everyone will be crippled with this device, it's an example of how the medical-industrial complex is not taking good enough care of the people it markets to.

[@lawthings2024]

my moms friend died to a medical device

[@skramamme685]

Yeah, metal on metal hip implants, vaginal mesh and many, may breast implants have been shown to be incredibly dangerous for an unreasonable % of those who receive those implants. I have had my body significantly affected by orthopaedic surgery, implants and mesh, and I know that there is not the same level of oversight in comparison to medications. Sure, as a consumer I need to due my research, but when I'm booked in to have surgery to fix an issues from a previous surgery I am not informed of what they're going to do bc sometimes they're not sure, they need to get in there and look around...and so I went from crossfit to cripple...fuck the medical device industry.

[@iKhanKing]

Just for the record, device sales reps aren't clueless here. Usually device representatives from the companies are biomedical engineers who have a comprehensive understanding of how the device works and how devices interface with the body. Doctors need to know what reps can inform and what they can't. It's obviously helpful for a device rep to help explain to a surgeon some of the principles by which a DBS device provides stimulation, and how external stimulation affects a neuron. Obviously they aren't trained to know what is and isn't safe, and the greater scope of patient outcome.

[@jonathonhazelton7688]

Yeah, that may be true, but a good Biomedical Engineer would be hired into sales says that they were not the best engineer, also they typically have a bachelors degree in a related field, but that is nothing near to what the is needed to know about safety and efficacy. Also Biomedical Engineers are not taught as much about medicine, because they have to know so much about engineer alone. As the Hip replacement showed the material science is important, and that is often a subject that is ignored in an engineering degree. So even a Biomedical Engineer is not the most informed person. I am an Mechanical Engineering Major with 6 credits left in a degree, and I can tell you there is so much that is not taught that would be important for medicine, that is why the device development is done by a team of doctors and engineers, not just engineers.

[@iKhanKing]

I have a degree in biomedical engineering. No we aren't taught about all the clinical guidelines and safety and efficacy. But unlike in ME or EE, what is emphasized in our coursework is how the body interacts with devices. The reason I use DBS in particular is that I have a background in neural stimulation. Understanding what different waveforms do, knowing, how which pathways a nerve cuff will most affect, etc. can be valuable to a physician. What I'm ultimately saying is that device reps have a critical role in medicine, but doctors must be sure to know when to listen to them and when not to listen to them.

[@mariekatherine5238]

👎👎 for my hernia mesh. It's always sticking me, like having a pin beside my umbillicus.

[@vyankateshmarathe7399]

11:03 I don't wanna make my doctor mad???WTF

[@Heelsandholster]

Thank you for posting this. I am a professor of health science and a mom who currently uses a medical device. Your insight is very helpful!

[@levidaisyyoung636]

The hospital is now denying they used mesh in me for a bowel prolapse. Their evidence on paper means more than my pain & suffering. I told them I didn’t want mesh before I had the procedure. I’ve had a hysterectomy & now I’m spotting. It’s like I feel it tear when I do stretching

[@angelica3744]

Thank you for adding nuance to the conversation and providing practical strategies for how to proceed in light of this information.

[@mitooquerer]

The film does a great job: it gives voice to the patients who had horrible medical issues. Nobody pays attention to those complaints until there is a huge amount of data. Internet and FB groups allowed these women to gather data and organize themselves. It is a group of very harmed people against the machinery of the manufactures, the lobby and the billion dollar industry. Please pay attention to the message in Bleeding Edge and make informed decisions! Just think: Essure and the pelvic floor mesh, both are nearly impossible to remove if you have any health issue after they are implanted!!

[@catherinebell9019]

The film does do a great job giving a voice to the voiceless. It does a great job bringing light to an inadequate approval process. The concern from the health care providers, and that ZDogg is mentioning, is that a patient who needs a pacemaker is going to spend hours grilling their ICU nurse and MD or refuse a lifesaving device because they saw a Netflix documentary. As scientists, we'd love to have the documentary also have discussed the 90% of people who got the Essure device and it worked as intended, and without complication. We would still advocate that an elective device with a 10% failure/complication rate should be taken off the market, and the documentary wouldn't make for compelling television, but that's certainly what makes our bullshit detectors start ringing when we watch these things.

[@amberlocklear2128]

Lol not true.. Hysterectomy removes essure...

[@amberlocklear2128]

Moron

[@amberlocklear2128]

At auto

[@dmstevens9569]

After watching this....the medical device business is some shady poop.... and I haven't even watched The Bleeding Edge yet.

[@NguyenNguyen-xv8li]

Zdogg when is your netflix show coming?

[@canadiankin]

The Sky Is Falling? Wait until your intestines fall out of a hole in your lower body or fragmented metals are floating around in your system, meshes adhering to everything inside of you, metal appliances shot into you over and over because they missed the first time. Tremors, or being told you have Alzheimer's yet it's caused by a procedure. See how you feel about a person saying that these people are exaggerating the issue. Wake up man. This film was important and exposing. One case it too many but there are thousands. Maybe you are one of them that doesn't want to be exposed or to have a conscience????? Money seems to matter way more to the "professionals" and pharmaceutical companies than our health.

[@canadiankin]

I stopped listening to this youtube after the crack about the sky is falling, BTW.

[@catmcalear1881]

I was explained at all. I was ask for a psychiatric evaluation since I didn’t want anymore kids. Besides my husband had to okay me getting the device. I had essure placed over 16 years ago. And now started seizure like symptoms but after examining my brain with a neurologist. No one can understand why this is happening to me. The last thing no one wants to say it can be the device.

[@nurseSean]

I liked the Film and it feels like you are praising it with faint damnation. It was emotional, sure, but not over the top. it didn't go into detail about how artificial hip problems are mitigated prior to the airing of the film. It didn't go into detail why someone might want to accept these risks. That's all I got as criticism. you stated the facts I got out of the film in a few minutes. You didn't seem to disagree with any individual part, only what they didn't say and the way they said it. Changing the FDA is a political action. Emotion has a place in politics. ('though it shouldn't dominant the argument) I had orthopedic surgery back in the 80's with a new device. the new device allowed a procedure with stated benefits (no permanent implant (a bar was removed after one year), minimal disruption of the blood supply at the location of the surgery). I had the opportunity to change insurance and have my surgery done by the surgeon that invented the procedure vs a surgeon that had watched the device be used once. it was an easy choice. the last follow up survey I got from the surgeons office was a telephone interview (by a med student) 10 years later.

[@docbailey3265]

And don’t get me started on gastric balloons...

[@KTravRuNEr]

I remember we reported issues w a medical device and the company blamed the doctors. They usually blame the doctors. It’s a real problem also.

[@davidmatke248]

Does anyone else find it ironic that a doctor becomes the patient when seeing his or her doctor? I like that it humanizes doctors.

[@Tinar55]

you can read and research and be advised by a surgeon as much as they like but when things go wrong doctors don't listen till it is too late . I have a tot sling and was assured less than 1% problems way safer than more natural measures using patients own tissue .i woke up from surgery with a heavy leg which has progressed to a wide range of problems including inflammation all over my body and autoimmune disorders and have since been ignored for 6 years till I ended up in a wheelchair because of nerves being severed in my pelvis by the device .. I wouldn't recommend it I am now stuck with a device that no one can remove that has taken my previously very fit and healthy active life away from me . doctors need to be educated, half of them don't even know what the various devices are .I don't know if it is different in the US to the UK but in the UK we just get told our issues are mental health rather than the real problem being investigated .

[@petitecontrebassiste]

thank you for talking about this! I've watched the documentary ad I felt it was pretty one-sided, but nevertheless went away from it with the message that I will get second opinions if I'm not comfortable with something. and this cleared it up nicely, thank you.

[@amyvalandingham3170]

There's nothing one sided about telling the truth.. It's sad that people can't handle hearing FACTS!!

[@happysmurfette]

You ROCK ZDoggMD🧚‍♀️🦋🙏🏼 I love the clarity and your thorough explanation-Thank•You. *Subscribed🤜🤛

[@jenniferberry120785]

Wtf seriously this needs to change.

[@Katharine848]

Personally, I'm waiting for a Tricorder, everything else is BS.

[@andreahultman8272]

Katharine Evans 🤣🤣🤣 #MakeItSo

[@fatimahaljawi2047]

loved that healthy talk, thank you

[@cherylradabaugh2720]

I thought that this was also on hip replacements .i ve seen nothing about that , only on implanted birth control devices.

[@gaylegonzalez71]

I had the essure placed in 2012, no issues since I've had it. I had no idea there were so many issues until I watched the bleeding edge last week -_-

[@nadinekonig5622]

You only represent a small percentage. Millions of women's lives have been destroyed. 100s of lives the device as worked for. And it's really just luck. It's not your time. Or maybe you're lying. Pharma sends out many goons disguised as patients to counter negative press of their crap.

[@gaylegonzalez71]

Nadine König no im not lying.....I asked to have my tubes tied after my 2nd child and was told they dont do that anymore and then got the essure after 3 months of couseling thru the Marine Corps to make sure I really wanted to get it.....I was only saying Im shocked to hear there are so many affected by it and I'm sorry to hear this.....

[@nadinekonig5622]

Count your blessings.

[@gyorgosgyorgos1133]

You are serving FDA , you got money to make this dirty stuff here. Shame on you !

[@PetsNPatients]

There needs to be better regulation to much conflict of interest for profit. Too much fraud!

[@chelseanewman9975]

I just had a hysterectomy using the da Vinci. It ended up nicking me. And I had a bless inside

[@mathilde9051]

Of course the trials are financed by the medical company. We need to prove that our devices are safe and effective by providing trials results. Obviously the company pays for it. Who else? We cannot simply ask the hospital to pay for the devices and for the training time and testing reports. We thus provide all that free of charge, which costs the company an enormous amount of money.

[@mathilde9051]

The word “Sponsor” is not the correct one to use here. The tests are not sponsored by the company, they are 100% created by the company. I am not saying it is better, but the word “sponsor” brings a negative image that there is corruption behind that or something. The company has no help to prove the safety and effectiveness of the device, it is all her and only her. What else can the company do? She pays for everything, she writes the protocoles, the trainings, the reports etc. It is the only way. Nobody else would just pay for that.

[@1MustangMom]

I just wrote up a critic of the documentary for my health and wellness class, there is a lot that the medical device industry did not consider, before they were approving all these medical devices for hip, shoulder, knee replacements, the Essure, and the mesh, Da Vinci robot, There is way too many devices and procedures that cause harm, when physicians are receiving kickbacks to these devices. Wrong thinking why would any smart researcher want to cause an inflammatory response to build scar tissue and permanently disable and sterilize thousands of women. Why isn't BioIdentical the 1st consideration above and beyond anything else. We all know heavy metals are dangerous. the Mesh is PolyPropylene, it is derived from petroleum it was developed by Shell Petroleum several years ago, and is used in clothing and Olefin Carpet. There is one thing i did not know about polypropylene that I learned from researching it is inflammable, not in the sense as a piece of paper, it melts into whatever is touching it in extreme fires etc etc etc. What is bioIdentical? Himalyan pink Salt is bioidentical it holds 84 minerals that is identical to our human dna. Stem Cell Research is bioidentical, they can grow Organs, using our own cells, and plasma, fda has not been out to heal the public for decades now. Why wasnt this research put through, when we have had so many children trafficed to evilness of the demonic ritual killings and for organ harvesting and their AdrenoChrome Blood.

[@briankappel6131]

Dude has shaped and dyed eyebrows and I just can't take him seriously after I noticed

[@jaguar4120]

How would you know that? Did you personally saw him dye his eyebrows? Lamo. 🙄😒😪🤔

[@swu1259]

very factual and true!

[@cellogirl11rw55]

KZbin, how is this comedy?

[@mon2863Hamilton]

You completely missed the important message of Bleeding Edge! I did not detect any hidden agenda!! HOWEVER I SDIS DETECT YOU BLAMING THE PATIENTS!!!!! JUST HORRIBLE!!! THE COMMERCIALS ALWAYS HYPE OF THE MEDICAL DEVICES AND THEIR MEDS!!! WHILE MINIMIZING THE RISK!! YOUR REVIEW WAS A FAILURE!!!!

[@docbailey3265]

Great video 👍

[@rodneyevans964]

Thank you

[@MZ-rv1bu]

You sound like controlled opposition, just my opinion.

[@hopkinsmedia]

I’m a NICU/maternal child nurse with experience spanning three decades and several USA states. I lost respect for you when you got cheeky about “the sky is falling” tone of the documentary. I don’t agree with you that the documentary was overly dramatic. I do, however, feel your voice tone and derogatory comments about the documentary are very inflammatory. It may be the case that you need to walk in the shoes of those who are harmed. You are clearly riding the wave of a very good documentary by trying to look like you have a better way of making the point(s), AND getting more followers, so that you have a financial interest in making your very animated comments. Come on back with some more comments when you’ve had a medical device change your life. It also sounds like your medical school and professional experience has not made you realize that the average person doesn’t have your level of education or even cognitive abilities. The onus of the usage of medical devices is inherently on the medical community, which includes pushing the FDA to do better. Patients can’t do what you can do. Get on it.

[@artgirl96]

❤

[@raymondbanks4103]

As he said, it's Netflix people!

[@betsyhampton8361]

The tens of thousands of women affected by Essure are real. We have been the guinea pigs, and thankfully Netflix is helping draw attention to the struggles of many who are still suffering.

[@OctopunkCypherpunkCyberpunk666]

KK We’re At With Kirby