Thank you, Amy DeWinter. I had planned to elevate this discussion as a group announcement on Tuesday but you're the third member to discuss the documentary this week. My next comments will highlight contributions from two other group members.

Richard Noctis wrote, "Cobalt-based hip replacements, vaginal mesh, robotic surgery devices (#Davinci), Bayer’s #Essure, FDA proccesses, government lobbying and more in this Netflix documentary on medical devices. A must watch for those in the $400B medtech industry.

He added this link to a LinkedIn article he wrote: https://lnkd.in/fqZvJxt

Elena Kyriacou wrote this LinkedIn article: "Netflix just killed the medical device industry" at https://www.linkedin.com/pulse/netflix-just-killed-medtech-industy-elena-kyriacou/

Julie Omohundro Haven't seen the documentary, not planning to rush out, but I might get around to it eventually. Based on the brief descriptions I've read, my only thought so far is that the release of this type of documentary three months before a major national election is probably not a coincidence.

Joe Hage thanks for link! Amy DeWinter - completely agree with you.

Julie Omohundro It seems very 2000s, from the US and EU perspectives, repeating the discussions that led to FDASIA in 2012 and the new EU regulations. It may be shocking! to people outside those jurisdictions, and to people outside the industry, but major changes have already been made in the US and EU in an effort to address the issues raised. "The market has already absorbed..."

Except as needed to address new technologies (eg, SaMDs and all things DNA), I don't see either Congress or the EC being open to significantly revisiting their device regulations for at least another two decades, so I don't see it having much of an impact in the US or EU. At most, it might make the road a tiny bit steeper for the apps crowd.

Might have an impact in other jurisdictions, depending on which Netflix viewers in those markets want to stream a video about the device industry rather than the latest action or horror flick.

Julie, I agree, but I wonder if this new exposure has made FDA nervous about approvals in the pipeline. I have a couple of clients awaiting 510(k)s and one with an imminent PMA. I think the bad press could mean short-term delays. The films paints FDA in a terrible light.

Julie Omohundro I've never seen FDA slow approvals because it was worried about anything other than the safety and effectiveness of the specific device it was reviewing. If the press reports problems with certain types of devices that FDA was not aware of, or that it wasn't confident it understood, then it is inclined to be cautious in its clearance or approval of similar devices. That is not the case here.

The only time I've seen FDA slow approvals in general was when the agency had been disrupted by efforts to improve it, usually starting with a purge at the top. This seems to have happened with Essure et al, but it happened already, and now it's done. Current FDA review of medical devices is under new management and new regulations.

If this film has an intelligent (?) agenda, it is related to the Essure litigation, which hasn't been going well for the plaintiffs, not to FDA regulation.

Julie O, this film was released in April so I don’t think it has anything to do with the upcoming elections.

Amy DeWinter, I was shocked by he NetFlix documentary "The Bleeding Edge."

The FDA 510(k) Functional Equivalency Medical Device approval process is broken because a new medical device can achieve FDA approval even if the 510(k) medical device petition is predicated on a formerly approved , dangerous, FDA recalled medical products.

"The Bleeding Edge" disloses incidents of sevvere adverse effects of Hip Replacement materials made from "cobalt steel."

The video testimonials from doctors and patient reviving this device were compelling The neurologic damage being caused by "cobalt toxicity" is deeply troubling.

The section of the documentary dealing with the "Essure" birth control device is self evident of a broken medical device approval and monitoring process. By placing the "burdan" of monitoring the approved medical device upon the device manufacturer is fundamentally flawed.

The sygical removal process of the spring-like Essure birth control device is tragic. Attempting to surgically remove the spring lije device from the patients fallopian tubes can cause the Essure device to snap, break and migrate into other areas of the pelvic and abdominal cavity - deeply troubling.

Julie Omohundro Kristin, it was shown at the Tribeca Film Festival in April. It wasn't released until last week.

Julie Omohundro It's also interesting that the film was released one week after Bayer announced it was discontinuing sales of Essure in the US.

Had Bayer wanted to sue the filmmakers for libel, I think it would have to show that it incurred damages due to the libel. Damages would probably have been in the form of lost sales. However, since there will be no more sales, there can be no damage, and therefore no litigation.

I need to see this film before commenting. Interesting questions and concerns you raise

Salvatore Domenic Morgera It’s all about unworthy approvals and lots of D, with inadequate R. Netflix did not harm the medical device industry, the industry did, not all, but many of the players. We are preparing Best Practices that should help to win back industry reputation, if followed.

I saw the documentary and found it illuminating. Since I am so close to the industry it was easy to decipher what was true and what was inflated. One does have to ask questions and be a proactive and be a smart consumer when it comes to their own health care. I do feel for those people that have sub optimal outcomes. I also agree that the FDA should not be run by those that were previously in the industry and maintain it’s course and goal of protecting the public. I also firmly believe that companies are not self monitoring as they should and that the FDA should try a different methodology in terms of monitoring products that are approved. At the end of the day we in the industry have to strike a fine balance and decide what risks we are take willing to take in order to reap the benefits of technology. I also agree that ‘new’ is not always better. This is a very polarizing topic but as a RN I known that the patient is the North Star of how I approach these matters.

Aside from what may or may not be appropriate in regards to the FDA or Netflix motives, I’m still floored that a sales rep would recommend that multiple foreign objects be injected into a patient, when the initial insertion was unable to be inserted correctly, and that the physician would follow that instruction without removing the prior inserted devices

Julie Omohundro Unless you assume that someone who has worked in the industry is inherently corrupt or incompetent or has been brainwashed into a state of permanent servitude to their former corporate "masters," there's no reason that someone previously in industry should not hold a position at any level at FDA for which they are otherwise qualified.

I've always thought that many of the shortcomings in FDA's efforts to regulate the industry reflected, in whole or in part, a lack of understanding of how the industry actually works, and that this is an understanding that can only be gained through experience in the industry.

Great topic and insight from all of you. Documentaries are usually from one person or groups perspective and it does create awareness to the public (looking at it from different views). For innovators in this awesome space to help the public and wellbeing of peoples lives, innovators will continue to evolve and get better, so will research that either save lives or make a populations health ultimately better. I am new to this group and I appreciate the acceptance to your group and website. I hope that you all have a great week.

I was appalled at the lack of oversight by the FDA. I didn't realize just how different the approval process is for devices vs. drugs and I'm guessing most other people also think it's the same. I just wish doctors would do a bit more research on behalf of their patients. I don't think it's realistic to expect patients to spend much time considering the risks/benefits of different devices but doctors should be more aware. Excellent documentary overall. Of course they had a specific perspective, but it's a topic that needs a bit of light thrown on it.

I saw the documentary and found it very insightful. It has energized my role in quality and has added to my belief that quality is very important when manufacaturing medical devices.

I do see the FDA making efforts to improve the process. I feel industry can add valuable insight. It will be interesting to see how FDA regulation changes with the new Medical Device Regulations in the European Union.

I liked the program in it's display of very large downsides to two devices that one could expect to have been better developed. I work in disease prevention (condoms and lubes) and delay to market once a product is found to be working well is also a large source of ill health - due to lack of prevention. There is also a quite large prevalence of conditions that medical devices could exacerbate from asymptomatic to symptomatic. The Documentary is not one that would give a generalised look at my industry's works. Scares don't help prevention programs.

Yes, these were devasting events. No doubt! I did not hear one single thing about the other side. How many devices that are cleared via 510k actually ARE improving patient outcomes and even saving lives? The documentary focus was only on several devices while there are hundreds of thousands that have been on the market, for a long time, with NO adverse effects. The entire industry should not be demonized because of these unacceptable devices. There should be stringent approval processes in place. And, technological advances must never be overlooked.

Joe Hage

Tsafrir Oranski wrote, "Couldn’t agree more, Amy. My colleague actually just wrote an article on the subject that echoes a lot of the things you write. Though his focus is somewhat more on the cyber implications of med devices. Have a look here and let me know what you think: https://hubs.ly/H0dh4Ps0."

Binseng Wang

Please read my commentary on this documentary at http://www.24x7mag.com/2018/08/technology-innovation-causing-bleeding/?ref=fr-title. Would welcome feedback, better insights and constructive criticisms.

Rather than just a scathing expose of our industry for me the film highligted weakness’s in the FDA approval process for Medical Devices.

This documentary should be required viewing for all people who work in the medical device industry. It illustrates the power of lobbyists in government and how that power can result in real harm to people who depend on agencies like FDA to ensure medical devices are safe. I’ve worked in the medical device industry for over 25 years and never realized that the 510k pathway was intended to be the exception not the rule. I also never realized that predicate devices can be devices that have shown to be defective and unsafe. As we embark on the new digital health frontier, the kinds of issues raised in this film will surely be more common since it is much easier to get approval for SaMDs since the FDA is actively encouraging these types of devices and is making it easier to get them approved. Very sad state of affairs.

I might add I was a bit surprised considering what we have to go through for the EU for a Class 2a device.

Binseng Wang

As I said in my article on 24×7 (see link in prior comment), one of the main problems is political interference on FDA. I think one solution would be to make FDA more independent, like the Federal Reserve, with officials appointed for an extended period of time (14 years in the case of the Fed) and whose decisions do not have to be ratified by the President or anyone in the Executive Branch. This would require a new law by the Congress. What do you think?

Thanks for bringing the documentary to all the industry insiders’ attention. For some of us old timers, we are probably not too surprised that things may go wrong and that motivations of people in the industry are not as honourable as we would like to think. However, we also need to keep things in perspective and not have a knee jerk reaction which will end up with increasing barriers and having smaller companies with exciting and vital new innovations going bust because they are waiting forever to have their product scrutinised to the nth degree by the FDA or other regulators. We also need to accept that we don’t always have the scientific knowledge nor the test methods nor the prior knowledge to fully identify each and every risk, and also not the knowledge to satisfactorily address each and every question that may come up, without it turning into a major project. The same is true for the people working for the regulators and we need to accept the limitations that they need to operate with.
Personally, for higher risk devices, I would advocate for a 510k with a conditional approval, with tight post market surveillance rules and only final approval once the post market data has been assessed, i.e. meet somewhere in between a 510k and PMA.

Interesting movie. Thank you for sharing, I would not have seen it otherwise.

I found the cobalt-steel hip replacements to be of greatest interest, as I suspect this is considered benign and there are likely many patients suffering right now and don’t know why. I hope every Orthopedic surgeon sees the movie or gets data on those implants.

The Essure story was tragic and very difficult to watch. I couldn’t even begin to imagine going through that. Of great disappointment, when Bayer announced they will discontinue sales in the USA, it was not out of safety concerns. In fact, they even stated: “Bayer is reminding women with Essure that the safety profile of Essure, the only Food and Drug Administration (FDA)-approved non-incisional form of permanent birth control, remains positive and unchanged.”
Unchanged, maybe. Positive, almost certainly not. Even a lay person can tell right away that the design of that device is insane. It appears that they did not do a single form of risk analysis on it whatsoever. Even if inserted correctly, its method of operation is to intentionally cause an inflammatory reaction in the body (which is trying to remove the foreign object). I am glad that if nothing else, Bayer was forced to retreat from the US market in large part due to this movie.

That said, I agree that many medical devices are fantastic products that help many millions of patients. I also agree however, that more stringent testing of them should be required, and that self reporting of adverse events is a flawed system that should be improved.

As a Nurse Inventor, I cannot wait to see it. I will watch it tomorrow. I keep safety number one in mind and insist on working directly with the engineers to make sure. My products and equipment save lives of Neonates and help the nurses to not make mistakes. I am looking forward to seeing the movie. On a different but related topic, as a nurse, I warn as many people as I can about: Unscrupulous medications where patients are permanently harmed, and the drug companies knew that their products were causing harm and death. NEVER TAKE FLUOROQUINOLONE ANTIBIOTICS. This is Cipro, Levaquin, and Avelox. You run the risk of being permanently disabled or dying. I have tendons that rupture and rip off my bones with the slightest movement. My bones just break. Yes, it is as bad as it sounds. These drugs kill bacteria by damaging the bacterial cell mitochondria. Problem is, they can cross into any and all cells of the body, including the brain. There are horrid side effects. Look at what this greedy doctor did to cover it up! http://ahrp.org/former-fda-commissioner-charged-in-federal-racketeering-lawsuit/ At least, do not join the FQAD patients. (Fluoroquinolone Acquired Disability) This is not a group you want to be in. Johnson & Johnson knew, as did Bayer. With the lawsuits flying from wrongful deaths, these companies are going to feel the financial pain. Just one pill, one time can kill you or disable you, even if you have taken it before without issue. Do not accept a prescription for these drugs from your doctor. Ask for something else.

Jeff Cranston

I used to be owner of Hipuniverse website that had 10's of thousands of members that helped to sort through the baggage of hip replacement subjects, from devices to surgeons to experiences, etc. I retired from it about 7 years ago.

In my own case, I had bilateral Wright Conserve + M/M hips put in at age 46 in 2001. So 19 years now. If I have problems due to debris, I would say it would be subtle. Regardless, after stumbling upon the show in Dec 2020 I would say 19 years ago, there was already evidence of the metal debris subject and I remember quite awhile ago the Depuy recall. And the Sulzer recall, etc. My hip devices at the time were considered fully investigational and I had to agree to the terms of having them implanted as part of the study. Albeit I only had two sets of xrays and answered a couple of sets of questions in a 6 month time instead of the 2 year time that was originally discussed for the investigation. They took many years to eventually get 510k approved. The Birmingham hips, M/M, similar to the Wright, were used at least a decade in England prior to these in the USA. I too was pretty shocked at the doctor's radical problems in the documentary and his patients that he quotes as 100% of 25 as having high cobalt. And yet the FDA/CDC weren't jumping all over this. So on the 17th of January I decided, why not get the cobalt testing, and I will. I will also discuss that mine are 19 yo. How much longer can they last. They do have quite a bit of mileage although I'm not an athlete like the doctor is. Thanks for reading. Feel free to email me if you would like follow-up. Oh, I also have a piece of surgical mesh implanted in my gut (although the documentary discusses women and there nether regions not men). So that is something that is still of some concern considering the installed it on the inside of my gut wall, where the organs are. (Abdominal hernia from a prior surgery).

I'll post a follow-up after the Ortho visit.