The dangerous health business | DW Documentary



artificial hips heart fells and stents are all modern medical miracles but what happens when they don't work you feel like a guinea pig who's Canadian a speed film those military medical products like hip implants and insulin pumps have to be safe and reliable and for less recent in Europe alone medical devices generate 100 billion euros in turnover every year but this system is out of control and in this report will explain why these devices can lead to serious medical complications or even death you can see the pain in this man's face he's no longer able to work everyday is an ordeal Thomas was cause back is full of plastic scrap an artificial disc in his spine has disintegrated into lots of tiny pieces these Manson's and the pain is the worst when I lie down like when I go to bed at night just ask my wife he's sitting on a powder keg one of the pieces slips out back there and that's that Vaska is one of more than a hundred patients who were given a defective artificial disc surgeons at this clinic near bremen specialize in removing the plastic pieces that have come loose dr. Carsten Ritter lung has treated dozens of these patients they're in a lot of pain first of all there's the actual physical discomfort caused by the defective discs and then there's the psychological distress because they know they've got this ticking time bomb in their body moist in two hours vasca will undergo surgery to remove the plastic scrap I'm really nervous I'm very scared this just isn't going to work out and the problems will continue beneath varnish this is a major operation dr. ritter-lang must avoid cutting into vital organs and blood vessels let's come to st but the first step is to examine the prosthesis you can see it there on the screen zip mention it's in pretty bad shape some plastic pieces have become lodged behind his spine I'm pulling out these little bits of white stuff it's like pulling out old pieces of chewing gum the surgeons place a new artificial disc in vaska's back the device is outfitted with titanium plates it's clear that the old prosthesis has severely damaged the vertebrae these are an absolute disaster this never should have happened over time the plastic device should have become fully integrated with the surrounding tissue so that the patient could gradually resume normal activities after surgery but that didn't happen here the plastic material started to disintegrate that probably wouldn't have happened if the discs were made of titanium Bosco's plastic disc was placed in his back at this clinic in the town of lair in northwestern Germany 113 other patients had similar operations here and two-thirds of them later had to undergo major surgery to correct serious complications implants can be a blessing for many but there are serious problems with these kinds of devices throughout Europe big fights up to five hundred thousand women worldwide are said to be affected by defective breast implants the implants are made of cheap industrial silicone it's often used to seal windows some implants have torn and caused cancer ten years ago the EU Commission warned that some medical devices pose a serious threat to public health experience indicates that the current system does not go far enough to protect patients but European Union is now trying to improve that system Dog Marrone parent is a special adviser to the EU commissioner for health and food safety she's been calling for more studies and tests for medical devices I was convinced and I still AM that implants and other medical devices are just as important as medicines so they must be properly regulated these devices should be subject to stricter quality control measures before they're put on the market the force often marked DAF in them but Road parent did not anticipate that her efforts at reform would provoke fierce opposition Thomas vasca had his repair surgery a few weeks ago he still doesn't know whether he'll ever be able to go back to work and he's still trying to figure out how this all happened via Tessa who's testing these products not experts apparently the history of artificial spinal disks highlights the deficiencies in the European product approval system this is the former headquarters of Rainier Technology in Cambridge England the company used to make plastic spinal implants Rainier was one of thousands of small businesses in Europe that were trying to break into the medical devices market about ten years ago Rainier started testing plastic discs on baboons after several months the animals were euthanized and autopsies were carried out the results of the autopsies were later leaked by a whistleblower dr. ritter-lang is looking through them right now the documents showed that there were serious problems with the discs as a man's eat and these are Studio dust design and how long span it's clear from these studies that the implants did not become properly integrated into the spinal system of X nisht all judgment and no homeless Hirst later I noticed similar complications in my patients who'd been given these discs and also a lift um but the company apparently ignored these results despite the warning signs Rainier now needed to carry out a series of clinical tests on humans some of those tests were conducted here at the pro spine facility in southern Bavaria it's not clear whether the clinic's chief physician was informed about the animal test he declined to talk to us about it andreas Rhoda was one of the test subjects he used to work as a butcher and also liked boxing but he could no longer do either in 2010 he was suffering from a herniated disc and a doctor recommended an implant Rhoda agreed to the surgery even though the disc had not yet been officially approved the circuit is good I decided to do it because I was in so much pain I was ready to do anything just put a stop to it and this doctor said he could fix it so I jumped at the chance I didn't think about it at all I'm sorry to say but it turned out to be a huge mistake later a total of 29 people signed up for the disc surgery the regulations that govern tests on medical devices are not as strict as those for medicines the manufacturers decide how long the studies will last and how many subjects will take part after just three months Rainier had the test results it needed to start marketing the plastic discs that was probably not enough time to evaluate the procedure properly yep that must keep books and I was kickboxing back then and after the operation I felt fine I went back to work I didn't think anything could go wrong in this interview a Rainier sales manager touts the positive results of the tests on people like andreas Rhoda what have you seen in your clinical studies today well this is where I want everybody to get quite excited actually because the clinical study which our headline study that we've done and which results in the C mark which you kindly mentioned has dramatically exceeded our expectations the patients that we've been privileged to meet in fact of all – a man reported you know no pain just a few months after andreas rodas operation Rainier requested and got approval from the British Standards institution or BSI it appears that BSI did not take into account the problems with the animal tests or the brevity of the tests on humans psi later told us that the tests met the required standards and that they were not aware of the results of the animal studies but BSI guidelines say those studies should have been included in the company's request and the agency did not say whether any doctors had tested the plastic discs including for the keynesian shots I can't imagine what sorts of people were doing the evaluation but if I'd been called in to consult as a spinal surgeon I would have rejected the application an issue through phone and if I'd been personally responsible for making the decision I'd have turned it down as a dependent Sulis on her foot in europe about 50 laboratories are currently testing medical devices in germany these include tuv South TUV Rheinland and DEKRA these facilities award seee certifications for things like heart pacemakers syringes and artificial hip joints most of the labs do not employ doctors manufacturers of medical devices can choose the facility they prefer and they pay for the certification process if a medical device passes the tests and receives the seee certification it can then be marketed throughout Europe the testing labs are sometimes called appointed authorities the largest such facility in Britain is BSI andreas rodent now wishes he'd never taken part in the study often swans each December 28th of 2013 it's a day that I'll never forget I've had a lot of pain in my life but nothing like the pain I have now never Rhoda eventually had to undergo emergency surgery to remove the bits of plastic that had broken away from the disintegrating plastic disc several more operations were required to clean out all of it Laura's life has changed significantly for the worse he's sterile now his nerves are damaged and he's physically incapacitated even shiny new all I really want is for someone to admit that they made a mistake but that won't happen because people never do that as andreas rota recovered from back surgery doctors at the clinic in Lair continued to use the plastic discs the federal government kept getting reports about serious problems with the devices but for years took no action to stop sales Germany's regulatory system has failed patients like Thomas vasca the clinic in lair declined comment for this report the clinic's head physician has now been fired in connection with illegal payments made by the manufacturer the British manufacturer has now filed for bankruptcy the former managing director told us that the devices did comply with all government regulations but he declined to comment on problems with the animal tests in 2014 this Dutch journalist showed how easy it is to get approval for a medical device in Europe a new car involves we're designing a device that's not safe at all a mesh implant that helps to stabilize the uterus we found all the component parts at the supermarket and took some photos now it's ready to go and Dad it's launched myq similar products are already on the market so the journalists didn't even need to sign up for clinical trials that use human test subjects an estimated 90% of such high-risk medical devices don't have to go through clinical trials either the journalists made an appointment at a seee test centre in Vienna and they filmed the meeting with a hidden camera mr. ela an open toe pointing to respect for often home contour and vena the official doesn't want to see the product itself he'll just rely on the documentation provided by the journalists no doctors took part in the process we agree with 99.9 neccessity is clinical evidence there is there are well known materials why not tuv Austria now says that in this case important documents were not submitted medical device manufacturers from all over the world have set up offices in Europe because the approval process is comparatively simple and cheap the approach which is a decentralized approach it's only an opportunity to make sure that the devices as a true in a timely manner to make them available for patient the medical device industry in Europe no provides over a half a million medical devices that are designed to help and provide solution to to patients that may well be the case but again and again there are problems in Europe with faulty devices hip replacement implants that fall apart breast implants that rupture and heart pacemakers that don't work properly tens of thousands of these devices have had to be replaced shouldn't they be tested much more carefully because before they come on the market the medical device industry as I said is mostly for mostly engaged in providing obviously solutions to patient translation and and works in the u.s. much stricter regulations apply a government agency the Food and Drug Administration monitors the approval process for medical devices some politicians have criticized Europe's approach in the European system patients are treated like guinea pigs show the manufacturers be allowed to finance certification of their products that money also pays the salaries of the test officials Dagmar old parent says Europe should have a state agency to approve medical devices just like the one that approves medicines with independent experts and medical advisors the problem is that the certification agencies are privately run not government runs that's led to a kind of business tourism where companies come to Europe because they can get certification for their products quickly and cheaply that's bad enough for a hairdryer or a mixer people want those products to be safe so that they don't explode when they use them but what about medical products that are placed inside your body if something goes wrong with them they could cause serious physical damage the manufacturers Lobby is fighting that proposal it says that the current regulations are enough to keep the device is safe and claims that new laws might threaten hundreds of thousands of jobs in this industry journalists around the world have also been investigating problems with medical devices they found a lack of oversight in some countries I found out too late that my hip replacement device was defective and I had to have it surgically removed there's been a big increase in recent years in the number of problems with medical devices in the u.s. the number of reported cases is nearly four million these include defective heart pacemakers artificial hips and insulin pumps but the industry has managed to weaken some of those strict regulations it was the pump that probably gave Stephen the overdose of insulin and killed him the manufacturers keep tight controls on product information German authorities don't have any idea how many devices are actually on the markets the companies are required by law to report problems that may damage patient's health but they often don't and the companies face no penalties companies such as Medtronic have been accused of playing down possible defects with their products Medtronic is the world's largest manufacturer of medical devices last year the company agreed to a forty three million dollar settlement with investors over allegations of improper payments to surgeons to cover up problems with a bone growth product the company denied any wrongdoing Paul Thacker is an investigative journalist who's done research on possible conflicts of interest in the medical research industry he's considered an expert on Medtronic basically their business model is based upon them giving money to doctors to then those doctors then to put devices into people or try and sell their device to other doctors what we started off originally doing was looking at fraud involving these doctors that were getting huge payments sent to them we eventually then started learning about this product called infuse have you had spine fusion surgery since 2002 infused was used as a bone graft material there were allegations that the product cause dangerous side effects the lawsuits started piling up a number of patients took part in class-action lawsuits against Medtronic Stephanie Claire had several back operations and in one the surgeon used the infused product a subsequent operation left her paralyzed from the chest down afterwards Claire's son Glenn quit his job to care for his mother it's very tough to watch somebody you love going through what they go through it's very tough just being able to walk to just lie my bed and throw my legs off the bed and stand up and go very simple things but that is very important but you don't have the ability to walk anymore your life becomes rather dull Stephanie Claire had no idea of the risks posed by infuse investigations later revealed that Medtronic actively sought to play down the harmful side effects of the product we're not just talking about trivial things we're talking about catastrophic complications to people of cancer sterility life-threatening airway events and they were not part of the original company sponsored publications we found that if you added up all of financial associations of the authors the individual trials that it was in millions of dollars one of the lead authors of many of the papers had more than 30 million dollars devices aren't that well understood by the average person so they don't realize the corruption in the device world and how it's actually in many ways worse we used to call the wild wild west it's just an open terrain of just craziness Medtronic denies it tried to minimize the risks of infuse it does say that its employees sometimes proposed changes to research articles about the product the company continues to reject allegations that it offered bribes or engaged in other improper behavior in any case Medtronic has now revised its policies Medtronic is a leading manufacturer of insulin pumps this company video promotes the products advantages it was my in the US a similar pump has been approved but children who use it must be at least 14 in Europe the age limit is much lower for many parents insulin pumps mean they won't have to give their kids regular injections this is Lenny the lion the mascot for Medtronic's diabetes treatment program an effort to put a friendly face on a large corporation new insulin pumps have been coming onto the market for four decades now but research data from the US indicates that no other medical device causes more serious health incidents I went upstairs and I could hear as soon as I walked up the stairs I could hear her breathing and sure enough whenever I went in the room she was like she was foaming from the mouth and I couldn't wake her out I heard my husband scream and when I came into the room my son was lying in his father's arms barely breathing but my husband was able to revive him the total number of incidents involving defective insulin pumps in Germany is not clear only a fraction of their reports end up with the appropriate federal agency the government has demanded that manufacturers and doctors do a better job of providing details Maximillian crew Zeus is 10 years old he was diagnosed with diabetes at the age of 2 he happily hits I've already gotten used to the fact that I've got to carry this thing around all day there's the tube it runs back here and connects to a catheter and the device squirts insulin through the tube into my body the insulin pump is programmed to Maximillian specifications he and his mother checked the data regularly because the boy's life depends on a device that functions properly all the kids in his class know that max suffers from diabetes his teacher Susana Valle is trained to deal with emergencies like the one that happened last June blood sugar was low and I was a little shaky I called my mom to tell her about it and she asked me what the reading on the pump was I said eight point eight and she said what the pump had released a huge dose of insulin by mistake and that could have been deadly for max I saw that there was something wrong with Maxie everyone else saw it too maybe there's a problem with his insulin pump max needed to get sugar into his system right away here the children show what they did to help him his hands were really cold we thought he'd gone into diabetic shock so he called the emergency doctor would steal max recovered but the incident left him shaken he was concerned about his health that nice I was pretty scared if I'd had an attack it nice I might have died Max's parents sent the insulin pump to an independent analysis facility it wasn't clear how much insulin ended up in his body and whether the pump or max himself was to blame the device have delivered such a significant dose normative if the device has met the required specifications there's no way it would have released that much insulin on its own new mods for in six hours in bolus like a dolphin we asked Medtronic about that and the company said that it's insulin pumps are safe the testing facility that approved the pumps declined comment for this report Germany continues to use this system of private inspection companies despite the problems that we've mentioned in 2012 MP yen's chuan who is now the Federal Minister of Health told the Bundestag that he supports the system Spahn said it's important to protect patients and the interests of the medical device companies the government has resisted attempts to reform the system the Germans didn't want to create a new regulatory authority and they were opposed to additional clinical studies they said in effect that they didn't need any more experts the German government has stuck to these positions in the European Parliament Dagmar wrote parent a member of the European Parliament at the time worked with her German colleague Peter Lisa to implement some reforms but Lisa still doesn't like the idea of a government testing agency I've been working on this for a long time and I believe that such an agency would not enhance product safety internal emails from the federal Health Ministry stressed the importance of patient protection but there are two other goals established acceptance of seee certification and faster market access I talked to health ministry officials about creating a new agency but they thought the idea of needing a license was totalitarian madness and chiffon is now the Federal Health Minister we caught up with him at an event sponsored by the pharmacy Lobby but he declined to comment on allegations that the monitoring of medical devices doesn't go far enough and we wanted to find out why he continues to support the use of private companies to test the devices spon has declined repeated requests for an interview juergen toma is a technical manager at a wine cellar several years ago he had hip replacement surgery the device included component parts made of titanium but four years later the implant had to be removed Toma suspected that the device had not been properly tested so he filed a lawsuit against the manufacturer it's unbelievable the mechanic when you work with machines like I do you need equipment that's been thoroughly tested for bending of abode seen the machines that I use are perfectly safe and they can last for years even decades but when it comes to medical devices the standards are obviously not as strict it makes you feel like you're just a guinea pig for the manufacturers the titanium hip implant kept rubbing against the nearby bones some of the metal scraps which can cause health problems ended up in the surrounding tissue when I heard about that process called micro movement I knew something was wrong here's my thigh bone and the implant device is right about here the shaft sits at an angle of about a hundred and forty-five degrees like this with micro movements every time you move your leg the hip implant rubs against the bone and that causes tiny bits of metal to break off that's how this stuff ended up in my body done in this baby do you've again eight years ago Toma filed a lawsuit against Zima by omate one of the market leaders in the manufacture of artificial hip implants this company video stresses the technological quality of its devices but Tamas attorneys claimed that the company knew there were problems with the implants sim review made denies that the court that was hearing Tamas law suit asked two experts to investigate the situation Daniele clues and Voltron Mittal Maia came to the conclusion that Zimmer Bo mate did not test the implant properly but the company had still managed to qualify for CES certification by submitting old tests that involved a similar device we're talking about the auto industry it would be difficult to compare one model of the same car with a newer model because the new design would include some modifications oh hi the investigators determined that the hip device was defective because it rubbed up against the surrounding bone structure that problem should have been identified through proper testing the health risks had already been widely reported these problems had been outlined in various research publications as early as 2003 so the situation was well known but at that time hip implants were not considered especially risky so the testing process was not terribly challenging an auditor who's worked for German seee certification agencies for 10 years agreed to talk to us on condition of anonymity he had serious concerns about how the quality control tests were carried out on various products one of the problems is that many of the auditors are freelancers and simply don't have the expertise to make qualified judgments none of them is really independent they almost never decide that a product is risky if they did the testing company could get into trouble and they might lose their job the auditor says that big companies have a lot of influence over the agencies if they're not happy with the test results they threatened to take their business elsewhere we went to a research industry conference to try to interview Bassel Achra he's a vice president at tuv south which is Germany's largest product testing facility Accra is also their top expert on medical devices we wanted to talk to him about reports of problems with heart pacemakers tested and approved by the TUV ich muss di kind of fact I prefer not to answer any questions right now we've received your questions and writing and we'll provide a written response we haven't received any response so far I have some questions about whether the tests are independent because the manufacturers pay for the certification process how can you guarantee your independence we follow the process that is outlined by the relevant authorities our tests are carried out in full accordance with the law and we still haven't received a written response from our agency more than 700 patients including Jurgen Toma received defective hip replacement implants many of those people have now organised a support group some of them filed suit against the manufacturer Cimabue made the legal proceedings have dragged on for several years attorneys for the company have tried to pin the blame on surgeons and even the patient's themselves a lot of these people now suffer from serious health problems devices to become sticky I could walk only 500 yards at a time and I've completely lost my sense of taste and smell my life just wasn't the same anymore I couldn't work like I used to and I couldn't walk very fast I'd really like to see a Court decide that there were flaws in the design and construction of these devices faced behind October 15 2018 a Regional Court in the city of Freiburg is to announce its verdict today Jurgen Toma hopes that the court will rule in favor of the plaintiffs Simha Bo mate's attorneys have used various legal tactics to try to delay a final Court ruling some of the plaintiffs are worried that this may happen again today a few of the people here cannot sit properly because of their defective hip implants Cimabue umit's attorneys did not attend today's court session the presiding judge says that the company's hip implants should never have been approved for sale he adds that the risks posed by the devices were well known and more tests should have been carried out the judge ordered simmer vo mate to pay Jurgen Toma twenty five thousand euros in compensatory damages but that was just the end of the first round sim review mate will certainly appeal the judge's ruling they continue to claim that their hip implants are not defective this case could take years to resolve meanwhile Dogma wrote parent has abandoned her effort to create a government agency that would impose stricter controls on medical device testing I wanted to draft legislation that would make sure that the devices would be safe for the patients and would allow the companies to make money but the new law doesn't do that but this was initially this is a sneaked in 2017 the EU approved new regulations on medical devices they include more clinical studies more controls on products and an independent database but they did not address the basic problem there are still no independent tests on the devices this is a diabetes charity event in Berlin sponsored in part by Medtronic Health Minister Yun's chuan is here spawns staff tells us that the ministry is committed to patient safety but it's not always possible to conduct extensive tests on some medical devices that means that private testing facilities will continue to be used [Applause] the regulations are due to go into effect in 2020 the medical device industry is now lobbying for a longer transitional period this is only it still makes me angry after all these years it's like a wound that won't heal I'm upset that we weren't able to make life safer for the around five hundred and twenty five hundred and thirty million people who live in the EU I feel as though I failed and I take responsibility for that I'm ashamed of myself and my colleagues it makes me so mad that I almost want to cry you

38 comments

  1. The medical “profession” number one cause of death in the USA. Cancer #3 heart #2 improper medical care #1

  2. Wheelchair or casket, they get paid the same. Ever wonder why doctors records are harder to get than nuclear weapons secrets?

  3. Health issue by itself is complicated enough and it is much more complex when it is mixed with money.

  4. There is, no doubt, that some phisicians has missindicated or missplaced the implants too.

  5. Interesting how Americans praise the European system of healthcare. Obviously it's has its own problems.

  6. The dangerous health business is a fascinating and poignant documentary! I truly did appreciate it so much. Thanks a lot for sharing! Keep it up!

  7. Well documented and a good piece of action information for everyone watching. I really support this noble cause, against the healthcare lobby for their half researched (failed) products.

  8. Then patients need to care more about themselves then their selfish behavior. Then they will not need these devices for extra time or life. Human beings focus is pleasure and selfishness with their lives. Hence, bodies give out or get polluted.

  9. The man that used to do kick boxing. All he wanted was an acknowledgement of a mistake and couldn't even get that.

  10. Not so fast with implants

    We don't trust other businesses as we rightly think that their owners and managers are out there simply to get our money and all

    And naively think that medical business is somehow an exception

    But that's never been the case

    In fact this is one of the most lucrative business out there, and just as it attracts some good folks, it is a mecca for some frighteningly cruel folks

    People are sucker for big titles and trust folks with hard-to-get licences a bit too much

  11. Our medical industry all over the world is in dissaray, it's all very consuming and of great concern.

    This surgeon working on the disintegrated disc is one of the most honest and extraordinary surgions in the world. We have a surgeon in Australia who can also do this work and repairs multiple disk's in one operation; Matthew Scott Young.

    Other surgeons will only do one day, as they make more money doing multiple surgeries per disk and they often don't get it right.

    I like this reporting but this production has too many rediculous advertisements.

  12. The surgeries alone did me in when they pinned my femurs; some surgeons for some bizarre reason were still using the methods of WW2 and cutting massive incisions through all the overlying tissue including a massive band of collagen that webs the hip muscles and bone together. Meanwhile proper surgeons would cut a 2" incision and use real time radio-graphical imaging to perform the surgery with catheters and surgical rods. The result was next to no scar tissue.

    The long term result is 30 years later I still have an 8" strip of scar tissue in each leg in the connective tissue webbing the entire hip architecture together, in the muscle and in the skin that impedes my ability to maintain physical labor relative to say holding a full time job? Considering I was a child and unable to waive my rights there should be a recourse for me to sue the doctor for AT LEAST 10 million dollars since it more or less ruined my life.

  13. How do they expect those titanium parts to interact with wifi and emf radiation, like pulsed microwave radiation?

  14. It makes me vomit when a former 25-year MEP dared to say she took her own responsibility for the failure of setting a German government Agency the role of which should have been to test each and every medical devices! IN 25 YEARS, A QUARTER OF A CENTURY, WHAT HAVE YOU DONE AND ACHIEVED AS A MEP? NOTHING! I just googled about it! ALMOST NOTHING! NO SIGNIFICANT LAWS, NO SIGNIFICANT INCENTIVES! That Dagmar Roth-Behrendt is what Americans call CONMAN, or conwoman, a genuine IMPERSONATOR! SHAME ON YOU! Reminder: the SPD was and still is part of most merkel's coalition governments! ALL'S SAID! Geh weg!

  15. Sue those medical companies producing those defective products. You are destroying life instead of preserving. You should be ashamed!!

  16. please remember a doctor's degree is a licence to kill. Medical field number 4 killer after brain strokes. Cancer , Heart failure, brian strokes and Doctors, diabetes etc.

  17. So sad. It seems people have shit job back surgeries have the same unhealthy look regardless where they are. I have seen someone (had several backbones fused) who looked almost exactly the same look like the man with that defective disc implant.

  18. Germans make best car in the world , what a shame they can’t make medical devices for there people ..

  19. I can't wrap my head around the European knee-jerk inclination to run to government for a solution and that somehow government can do a better job than the private sector, when that is disproven time and time and time again. Is there no civil liability system in Europe? Why are these people not suing the manufacturer into the ground for what is obvious fraud? Additional government regulation is not the answer. All that will do is increase the cost to market, the time to market, and put patients in danger who need these life saving devices.

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