This will be. Just a reminder of the top story were following for you here today on d w news israel goes to the polls to decide whether political newcomer betty gaffes should one seat for term Prime MinisterBenyamin Netanyahu its a both a certain to have a long term impact on the region. Coming up next the implants files are investigated a documentary on medical implants stay with us. The first economy plus a. Grand arrives. Join your reckoning on her journey back to freedom. In our interactive documentary during the regular season
returns home on t w dot com tanks. Artificial hips heart fellows instance are all modern medical miracles but what happens when they dont work. You feel like a guinea pig for who couldnt. Get to so many medical products like implants and Insulin Pumps have to be safe and reliable. And for listeners. In europe alone medical devices generate One Hundred Billion Euros in turn over every year. But this system is out of control and in this report well explain why. These devices can lead to serious medical complications or even death. You can see the pain in this mans face hes no longer able to work every day is an ordeal. Thomas was because back is full of plastic strips and artificial disc in his spine has disintegrated into lots of tiny pieces of sums and the pain is the worst when i lie down like when i go to bed at night the flumes just ask my wife and one of health long as its unclear if hes also hes sitting on a pallet keg one of the pieces slips out back there and thats us i cant. Vaska is one of more than one hundred patients who were given a defective Artificial Disc Surgeons at this clinic there braman specialize in removing the plastic pieces that have come loose. You dr carsten rich a long history to dozens of these patients. To lose their license to four who are close or theyre in a lot of pain. First of all theres the actual physical discomfort caused by the defective disc and then theres the psychological distress to fix it because they know theyve got this ticking time bomb in their body. But hes not used to that theres no boost. In two hours of oscar will undergo surgery to remove the plastic scrap. The shop people im really nervous because im very scared that this just isnt going to work out and the problems will continue it. Binnys publish. This is a major Operation Doctor it along must avoid cutting into vital organs and blood vessels. Thats come to us through the first step is to examine the prosthesis and you can see it there on the screen its one should this impromptu i think you should think its in pretty bad shape to support all of this in. Some plastic pieces have become lodged behind his spine. Is what im pulling out these little bits of white stuff. So its like pulling out old pieces of chewing gum you see. The surgeons place a new Artificial Disk in bus goes back the device is outfitted with to tinian plates its clear that the old prosthesis has severely damaged the vertebrae. It is
also 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 didnt happen here. The plastic material started to disintegrate. That probably wouldnt have happened if the discriminative to teenie him. Because plastic disc was placed on his back at this clinic in the town of lear in northwestern germany. One hundred thirteen 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 or up to Five Hundred Thousand women worldwide are
said to be affected by defective Breast Implants and from tossing the implants are made of Cheap Industrial so a countries called for the us i think its often used to seal windows or affects the good doctor just a nickel some implants have torn and cause cancer and it isnt. Ten years ago the e. U. 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. The European Union is now trying to improve that system. Dogma ruled parent is a special advisor to the e. U. Commissioner for health and food safety shes been calling for more studies and tests for medical devices. Vada from about soil 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 thats the suit to these devices should be subject to strict to Quality Control measures before theyre put on the market the force of the unmarked stuff and on. But road parents did not anticipate that her efforts at reform would provoke fierce opposition. Thomas waskow had his Repair Surgery a few weeks ago he still doesnt know whether hell ever be able to go back to work. And hes still trying to figure out how this all happened. Who is testing these products for the lord not experts apparently on. 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 brainier was one of
thousands of Small Businesses in europe that were trying to break into the medical devices market. About ten years ago started testing plastic disks and baboons. After several months the animals were euthanized and autopsies were carried out. The results of the autopsies were later leaked by a whistleblower. Doctor researcher long is looking through them right now the documents showed that there were Serious Problems with the discs. As among the studio and highlands pay its clear from the studies that the implants did not become properly integrated into the spinal system vics nish to. Host later i noticed similar complications in my patients whove been given these discs you know what inputs in the bowels who only of tom. But the company apparently ignored these
results despite the warning signs. No. Brainier 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. Its not clear whether the clinics Chief Position was informed about the animal tests he declined to talk to us about it. Is right there was one of the test subjects used to work as a butcher and also liked boxing but he could no longer do either. In Two Thousand And Ten he was suffering from Herniated Disc and a doctor recommended any plan to go to agreed to the surgery even though the disc had not yet been officially approved. The second this couldnt be who i know i decided to do it because i was in so much pain schmidts and i was ready to do
anything to put a stop to it. And i stood up and when an od and the doctor said he could fix it it would be so i jumped at the chance to get i stood up i didnt think about it at all i mean im sorry to say but it turned out to be a huge mistake. And later why this decreased if it was not that. A total of twenty nine people signed up for the disc surgery. The regulations that govern tests on medical devices are not as strict as those for medicines. And 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 disks that was probably not enough time to evaluate the procedure properly. Yet the must keep books and i was kickboxing back then and after the operation i felt five got i by the tail of the noise when i went
back to work i didnt think anything could go wrong plus i seen come very close to theres a robbery in this interview a rainier Sales Manager touts the positive results of the test on people like andrea. Where do you see it in your clinical studies today well this is where we all want everybody to go quite excited actually because the Clinical Study which Headline Study that weve done which results in the c. Dimension. Has dramatically exceeded our expectations the patients that weve been privileged to meet in fact i was who was you know know. Just a few months after andreas rhodas Operation Brainier requested and got approval from the British Standards Institution or b. S. I. It appears that b. S. I. Did not take into account the problems with the animal tests or the brevity of the tests on humans. B. S. I. Later told us that the tests met the required standards and that they were not aware of the results of the animal studies. But b. S. I. Guidelines say those studies should have been included in the companys request. And the agency did not say whether any doctors had tested the plastic disks. Concluded for coming. I cant imagine what sorts of people were doing me a valuation but if id been called into. Insult as a spinal surgeon i would have rejected the application. In issue. And if id been personally responsible for making the decision ive turned it down. Kind of for. In europe about fifty laboratories are currently testing medical devices in germany these include t. U. V. Self t. U. V. Rhineland and. These Facilities Award c e 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 casar to cation it can then be marketed throughout europe. The testing labs are sometimes called appointed authorities the largest such facility in britain is b. S. I. Under a us rodent now wishes hed never taken part in the study. Athens form six december twenty eighth and twenty second its a day that ill never forget ive had a lot of pain in my life but nothing like the pain i have now never go. To 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. Or does life has changed significantly for the worse hes sterile now his nerves are damaged and hes physically incapacitated. Even trying to move all i really want is for someone to admit that they made a mistake this video but that wont happen because people never do that made him feel much. As andreas wrote a recovered from back surgery. Doctors at the clinic in lear 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. Germanys regulatory system has failed patients like thomas waskow. The clinic in leer declined comment for this report. The clinics 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 Two Thousand And Fourteen this dutch journalist showed how easy it is to get approval for a medical device in europe. Were designing a device thats not safe at all implant that helps to stabilize the uterus we found all the Component Parts at the supermarket and took some photos of it now its ready to go to court. And back. These are similar products are
already on the market so the journalists didnt even need to sign up for Clinical Trials that use human test subject. Arm an estimated ninety percent of such high risk medical devices dont have to go through Clinical Trials either. And if it was funky the journalists made an appointment at a c. E. Test center in vienna and they filmed the meeting with a hidden camera. Spec but often come to work in Vain The Official Doesnt Want to see the product itself hell just rely on the documentation provided by the journalists. Or no doctors took part in the process. Because. We will agree with Ninety Nine Point nine. But says its not as. If there is there are. Groups. Why the. T u v 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 of the centuries approach a new approach unity to make sure the good devices as approved in a timely manner to make them really before pushing the medical Device Industry in europe you know provided through overhauls. Nuclear devices that are designed to. Help provide solutions truer 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 dont work properly Tens Of Thousands of these devices have had to be replaced. Shouldnt they be tested much more carefully because before they come to market the medical diversion whose roots it is most of foremost can duration providing obviously you should or should be should try solution and and worse. In the us much stricter regulations apply a Government Agency the food and Drug Administration monitors the Approval Process for medical devices some politicians have criticised europes approach is that. In the european system patients are treated like guinea pigs. Should the manufacturers be allowed to finance certification of their products that money also pays the salaries of the test officials. Dogma ruled to bear and says europe should have a state agency to approve medical devices. Just like the one that approves
medicines with independent experts and medical advisors. What was never. A problem is that the Certification Agencies are privately run not government run thats also thats led to a kind of Business Tourism where Companies Come to europe because they can get certification for their products and cheaply. And. Thats bad enough for a hairdryer or a mix. When. People want those products to be safe so that they dont explode when they use them that. But what about medical products that are placed inside your body and if something goes wrong with them they could cause serious physical damage from this disastrous. The manufacturers lobby is fighting that proposal it says that the current regulations are enough to keep the devices 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. Theres 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. Lees 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. He gave stephen the overdose of insulin and killed him. The manufacturers keep tight controls on product information. German authorities dont have any idea how many devices are actually on the market. The companies are required by law to Report Problems that may damage Patients Health but they often dont and the Companies Face no penalties. Companies such as medtronic have been accused of playing down possible effects with their products. Tronic is the Worlds Largest manufacturer of medical devices. Last year the company agreed to a forty three Million Dollars 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 factor is an investigative journalist whos done research on possible conflict
of interest in the medical Research Industry. Hes considered an Expert On Bed Tronic basically their Business Model is based upon them giving money to Doctors Today and those doctors and to put devices in the 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 have actually then started learning about this product called infuse have you had Spine Fusion Surgery since Two Thousand And two even fused was used as a bone graft material there were allegations that the product cause dangerous side effects the lawsuits started piling up people in pain news or paralysis. A number of patients took part in Class Action Lawsuits against medtronic. Stephanie clear had several back operations and in one the surgeon used the infused product. A
subsequent operation left her paralyzed from the chest down afterwards clares son glenn quit his job to care for his mother its very tough to watch somebody you love going through what they go through its very tough just be able to walk to just lie in my bed can throw my legs off the bed and stand up and go very simple things but that is very important when you dont have the ability to walk anymore your life becomes your adamo. Stephanie claire had no idea of the risks posed by infuse investigations later reveal that medtronic actively sought to play down the harmful side effects of the product. Were not just talking about trivial things were talking about catastrophic complications to
people of cancer to realty life threatening or whatever but its very were not part of the original Company Sponsored publication and we found that if you added up all the Financial Association of the authors for individual trials that it was a Million Dollars one of the lead authors of many of the papers. More than thirty Million Dollars devices arent that well understood by the average person so they dont realize the corruption in the device world and how its actually in many ways worse we used to call the wild wild west its 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 product advantages. Was that it. Was a little. Smaller. In the u. S. A similar pump has been approved but children who use it must be at least fourteen in europe the age limit is much lower. Than many parents Insulin Pumps mean they wont have to. Give their kids regular injections. This is the lenny of the lion the mascot for medtronic sty of his 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 that walk up the stairs i can hear her breathing and sure enough whenever i went in the room she was my shoulder in from the north and i can work around. The moment. I heard my Husband Scream and when i came into the room my son was lying in his fathers 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 the reports end up with the appropriate federal agency. The government has demanded that manufacturers and doctors do a better job of providing details. Next a million cruise use is ten years old. He was diagnosed with diabetes at the age of two. Time from ive already gotten used to the fact that ive got to carry this thing around all day. As it is his will is the chip it runs back here and connects to a catheter. And the device Squirts Insulin through the chip into my body. Because. The insulin pump is program to maximillian specifications. He and his mother check the data regularly because the Boys Life Depends on a device that functions properly. All the kids in his class know that max suffers from diabetes. His teachers design
of all is trained to deal with emergencies. Like the one that happened last june. And from to two oclock i felt like my blood sugar was low and i was a little shaky. Said tyke only one and i called my mom to tell her about it. And she asked me what the reading on the pump us. I said eight point eight kilometers and she said whats wrong yes. The pump had released a huge dose of insulin by mistake and that could have been deadly for max. Chad thank you ok man i saw that there was something wrong with maxie. Everyone else with two maybe theres 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. Now that have kept him going like his hands were really cold we thought he had gone into diabetic shock so we called
the Emergency Doctor what. Max recovered but the incident left him shaken he was concerned about his Health Finding and now that nice i was pretty scared if id had an attack at nice i might have died. Maxs parents sent the insulin pump to an independent Analysis Facility It wasnt clear how much insulin ended up in his body and whether the pump or max himself was to blame mr morsi was. Good the device have delivered such a significant dose. You know didnt know much and if the device has met the required specifications theres no way it would have released that much insulin on its own mail its for and since i was born as for you gave me the. We asked medtronic about that and the company said that its 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 weve mentioned in Two Thousand And twelve m. P. s sean who is now the federal Minister Of Health told the bonus talk that he supports the system said its important to protect patients and the interests of the medical device companies. The government has resisted attempts to reform the system. But example. Is it the germans didnt want to create a new regulation real farsi and they were opposed to additional clinical studies. They said in effect that they didnt need any more experts. The german government
has stuck to these positions in the European Parliament. Talk more old bear and a member of the European Parliament at the time worked with her german colleague peter liza to implement some reforms. But liza still doesnt like the idea of a government testing agency. But its often front government in ive been working on this for a long time and i believe that such an agency would not enhance product safety. But do it at the. Internal emails from the federal Health Ministry stressed the importance of Patient Protection but there are two other goals. Established acceptance of see. Certification. And faster market access. Starts up and i took to Health Ministry officials about creating a new agency. But they thought the idea of needing a license was totalitarian Madness Mister thats what somehow. Inspan 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 doesnt go far enough. And we wanted to find out why he continues to support the use of private companies to test the devices. Spun has declined repeated requests for an interview. You havent thoma 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 implants had to be removed. Toma suspected that the device had not been properly tested. So he filed a lawsuit against the manufacturer. To me because im slow because its unbelievable. Busy even the mechanic when you work with machines like i do you need equipment thats been thoroughly tested. To be new of abode seen and heard this on the machines that are used are perfectly safe and they can last for years even decades. But maybe she does but when it comes to medical devices the standards are obviously not as strict or disfigure it makes you feel like youre just a guinea pig. The manufacturers. Which attorney unhip implants kept rubbing against the nearby bones some of the metal scraps which can cause Health Problems ended up in the surrounding tissue. Is what nick when i heard about that process
called Micro Movement i knew something was wrong if you should over saying heres my five bone and the Implant Device is right about here. The shaft sits at an angle of about One Hundred Forty Five degrees like this. And. They didnt meet with Micro Movements every time you move your leg they hit him a plant rubs against the bone. Of this hole and that causes tiny bits of metal to break off life and. Thats how the stuff ended up in my body. He done in this really good baby you bogey. Eight years ago told me i filed a lawsuit against him a deal made one of the Market Leaders in the manufacture of artificial hip implants this Company Video stresses the technological quality of its devices but thomas attorneys claimed that the company knew there were problems with the implants similar vehement denials that. This was the court that was hearing thomas lawsuit asked two experts to investigate the Situation Daniel clues and vall from middle myo came to the conclusion that similar mate did not test the implant properly its between you think you can but the company had still managed to qualify for c. E. Certification by submitting old tests that involved a similar device. This britain has got to be just as if we were 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 to maga than. When they were that. The investigators determined that the hip device was defective because it rubbed up against the surrounding known structure that problem should have been identified through proper testing the health risks had already been widely reported. Present communion with
these problems had been outlined in various Research Publications as early as Two Thousand And three 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. And auditor whos worked for german sees Certification Agencies for ten 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 dont 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 Great Companies have a lot of influence over the agency if theyre not happy with the test results they threaten to take their business elsewhere. We went to a Research Industry conference try to interview bussell across hes a Vice President at t u v south which is germanys largest product Testing Facility. 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 t u v. I spoke to chip at the time the fact that i prefer not to answer any questions right now but interesting that weve received your questions in writing and will
provide a written response but. As of this line were going to kind of we havent received any response so far and i have some questions about whether the test independent because the manufacturer has paid for this Occasion Process and how can you guarantee your independence especially going to sets we follow the process that is outlined by the real. But authorities in our tests are carried out in full accordance with the law before the courts are doing such to. Me. And we still havent received a written response from presidency. More than Seven Hundred patients including youre going toma receive defective Hip Replacement Implants many of those people have now organized a support group. Some of them filed suit against the manufacturer similar. The Legal Proceedings have dragged on for several years i think attorneys for the company have tried to pin the blame on surgeons and even the patients themselves
when a lot of these people now suffer from Serious Health problems. Devide just evicted me i could walk only five hundred yards at a time and ive completely lost my sense of taste and smell this instant from the room unassisted my life just wasnt the same anymore but i couldnt work like i used to and i couldnt walk very fast he. Told us you have to id really like to see a court decide that there were flaws in the design and construction of these devices and try doing for. October fifteenth twenty eighteen. The Regional Court in the city of fribourg is to announce its verdict today. Youre going told the hopes that the court will rule in favor of the plaintiffs. Because well this group
often says. To him of you mates 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. With a few of the people here cannot sit properly because of their defective hip implants. Similar view mates attorneys did not attend todays court session. The Presiding Judge says that the companys 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 similar being made to pay youre going toma Twenty Five Thousand euros in compensatory damages. But that was just the end of the first round. Will certainly appeal the judges ruling. They continue to claim that their hip implants are not defective. This case
could take years to resolve. While dogma ruled parent has abandoned her effort to create a Government Agency that would impose stricter controls on medical device testing. Forty i think thats given the 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 towards them good to see that the new law doesnt do that it. But this was dont just look this is a sneaked. In twenty seventeen the e. U. 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 yen spawn is here. Sponsor staff tells us that the ministry is committed to Patient Safety but its not always possible to conduct extensive tests on some medical devices. That means that private Testing Facilities will continue to be used. As. The regulations are due to go into effect in Two Thousand And twenty. The medical Device Industry is now lobbying for a longer transitional period. This is a stylish this isnt enough it still makes me angry off to all these years. Its like a wound that wont heal thats money and im upset that we werent able to make life safer for the around Five Hundred Twenty five hundred thirty Million People who live in the e. U. I feel as though i failed and i take responsibility for that for the few im ashamed of myself and my colleagues it makes me so mad that i almost want to cry in. Tara poker. U. S. President donald trump is ignoring the rules of free trade and setting Global Markets on edge but are europe in germany doing that much better. Who are the winners and losers in
a high stakes game. Shows up in thirty minutes on d w. Such. A crush can eviscerate. The buy and destroy still of men fighting in the hunted condition of the classics. And leipzig scored the most beautiful goal of the day in a few years come back against a little. Kid. On the. Sometimes books are more exciting than real life. Preparing to greet. One of theres no escape. List the german must treat. Such. Place. This is really is coming to light. From both ends with the next briggs the deadline just three days away to reserve me has just arrived in berlin within the last few minutes the british Prime Minister is Holding Talks or chance the angle of machall and then she will head to paris to meet president amman in the core means looking to buy more time on the eve of a crucial summit also on the program. Israelis are voting in