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 some of the medical products like implants and insulin pumps have to be safe and reliable and. Lets listen. In europe alone medical devices generate 100000000000 euros in turn over every year. But this system is out of control and this report will 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 scrap and artificial disk in his spine has disintegrated into lots of tiny pieces he smeared sins 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 mother fall fun at some kind of hes also hes sitting on a pallet keg one of the pieces slips out back then and thats the last month alone a choice. Is one of more than 100 patients who were given a defective artificial disc surgeons at this clinic near braman specialize in removing the plastic pieces that have come loose. Your dr Kirsten Ritter long has treated dozens of these patients. To their licensed before who are close or theyre in a lot of pain. First of all theres the actual physical discomfort caused by the defective disk and then theres the psychological distress to fix it because they know theyve got this ticking time bomb in their body. But theres no clues to that theres no boost. In 2 hours of moscow will undergo surgery to remove the plastic scrap. The shop im really nervous but im very scared that this just isnt going to work out and the problems will continue to. Beamish publish. This is a major operation dr it along must avoid cutting into vital organs and blood vessels. Thats come to us through the 1st step is to examine the prosthesis so you can see it there on the screen its the one should be on the front i think it should be its in pretty bad shape. But. Some plastic pieces have become lodged behind his spine. That is im pulling out these little bits of white stuff. So big its like pulling out old pieces of chewing gum oh see. The surgeons place a new artificial disk in vos because back the device is outfitted with to tinian plates its clear that the old prosthesis has severely damaged the vertebrae. 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 they discriminated to tainio. Most because plastic disc was placed in his back at this clinic in the town of blair in northwestern germany. 113 other patients had similar operations here and 2 thirds of them later had to undergo major surgery to correct serious complications. The implants can be a blessing for many but there are Serious Problems with these kinds of devices throughout your. Big fight so i have to. 500000 women worldwide are said to be affected by defective breast implants implant tatis and the implants are made of cheap industrial silicon valleys called for and thats i think its often used to seal windows affects the good baptist and it was some implants have torn and caused cancer and it isnt. 10 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. Vodafone about sort but 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 a suit to these devices should be subject to strict to Quality Control measures before theyre put on the market before us of the unmarked stuff and then. But rod 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. Fair to set up whos testing these products with 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. Plastic spinal implants brain year was one of thousands of Small Businesses in europe that were trying to break into the medical devices market. About 10 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 is looking through them right now the documents showed that there were Serious Problems with the disks. Its clear from the studies that the implants did not become properly integrated into the spinal system nish to. Later i noticed similar complications in my patients whove been given these discs but you know what inputs and. Tom. But the company apparently ignored these results despite the warning signs. Granier no 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 test he declined to talk to us about it. Or 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 2010 he was suffering from herniated disc and a doctor recommended any plan. To agreed to the surgery even though the disc had not yet been officially approved. The 2nd is come in and i decided to do it there because i was in so much pain schmidts and i was ready to do anything just put a stop to it. And. When an od and this doctor said he could fix it so i jumped at the chance of what i should have done i didnt think about it at all. Im sorry to say but it turned out to be a huge mistake. Glad i wasnt going to stay for not that. A total of 29. 00 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 3 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. I must keep books and i was kickboxing back then and after the operation i felt 5 got i by the kind of the know so i went back to work i didnt think anything could go wrong plus plus the income. Very pleased theres a robbery in this interview a rainier Sales Manager touts the positive results of the test on people like andreas would. Want to be seen in your clinical studies today well this is where we want everybody to go quite excited actually because its illegal study which headline study that weve done which results in the siebel as you mention. Has dramatically exceeded our expectations the patients that weve been privileged to meet in fact of all who was you know you 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 the side 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. And concluded for coming in as im sure i can imagine what sorts of people were doing me a valuation but if id been called in to consult as a spinal surgeon i would have rejected the application. In issue. And if id been personally responsible for making the decision i have turned it down and move. Forward. In europe about 50 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. For testing labs are sometimes called appointed authorities the largest such facility in britain is b. S. I. Know wishes hed never taken part in the study. After december 28th and 2013 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. Know the. Road 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. All i really want is for someone to admit that they made a mistake but that wont happen because people never do that they didnt feel up to it. As andreas wrote it recovered from back surgery. Doctors at the clinic in lyric 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 layer 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 2014 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 tied to a mish 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 journalist didnt even need to sign up for Clinical Trials that use human test subject. Arm an estimated 90 percent of such high risk medical devices dont have to go through Clinical Trials either. And if a funky journalist made an appointment at a c. E. Test center in vienna and they filmed the meeting with a hidden camera. Often come to work and. 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 99. 9. But says that. There is. No. 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. Approach which is of the centuries approach and of course unity to make sure the bronsons as approved in a timely manner to manage them really before pushing the medical Device Industry in europe you know provided over a. 1000000 new devices but all designed to. Help one provide solution 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 on the market the medical diversion issues that is most of foremost can engage in providing obviously. Sure issues to be sure interests are different and and worse. 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 criticised europes approach toward the boys. 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. Drug motorola to bear and says europe should have a state agency to approve medical devices. Just like the one that approves medicines independent experts and medical advisers on what was never. The problem is that the certification agencies are privately run not government run. Health thats led to a kind of business tourism where Companies Come to europe because they can get set if occasion for their products and cheaply to open on their own until. Thats bad enough for a hair dryer or a mix thats when. People want those products to be safe so that they dont explode when they use them and that. But what about medical products that are placed inside your body. If something goes wrong with them if they could cause serious physical damage from this disaster was. 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 us the number of reported cases is nearly 4000000. 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. In the manufacturers keep tight controls on product information. German authorities dont have any idea how many devices are actually on the market. 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 43000000. 00 settlement with investors over allegations of improper payments to surgeons to cover up problems with a bone growth product. The company denied any wrongdoing. Call thacker is an investigative journalist whos done research on possible conflict of interest in the medical Research Industry. Hes considered an expert on medtronic. Basically their Business Model is based upon them giving money to doctors to do those doctors and to put devices in people or try and sell their device to other doctors 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 2002 youve infused was used as a bone graft material there were allegations that the product caused dangerous side effects into nerves and the lawsuits started piling up people in pain numbness 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 all 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 wall anymore your life becomes sirah the doll. Stephanie claire had no idea of the wrists posed by infuse investigations later revealed 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 really be life threatening or whatever but they were not part of the original Company Sponsored publication and we found that if you added up all the financial associations of the authors for individual trials that it was a 1000000. 01 of the lead authors of many of the papers had more than 30000000. 00 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. Taking time that it. Was settled. For. 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. Than many parents insulin pumps mean they wont have to. Give their kids regular injections. This is lenny 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 off of the market for 4 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 could hear her breathing and sure enough whenever i went in the room she was my shoes woman from the north and i can work around. At 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 1000000 cruise use is 10 years old. Ready he was diagnosed with diabetes at the age of 2. Time from ive already gotten used to the fact that ive got to carry this thing around all day. As it is years old is the chip it runs back here and connects to a catheter. And the device squirts insulin through the chip into my body. The insulin pump is programmed 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 teacher says on of all is trained to deal with emergencies. Like the one that happened last june. Head into it so close i felt like my blood sugar was low and i was a little shaky. Said click away from him and i called my mom to tell her about it. And she asked me what the reading on the pump was. I said 8. 8. And she said was right. The pump had released a huge dose of insulin by mistake and that could have been deadly for max. And for alchemy i saw that there was something wrong with maxie. Everyone else or to maybe theres a problem with his insulin pump and. Max needed to get sugar into his system right away here the children show what they did to help him. And that was kept from him 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 theyre not 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 to devise have delivered such a significant dose. And though didnt know much if the device had met the required specifications theres no way it would have released that much insulin on its own noids for instance i was born is 500. 00 and. 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 2012 mpg young man who is now the federal minister of health told one does 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 i do know 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 anymore experts in. The German Government has stuck to these positions in the European Parliament. Ive talked to bear and a member of the European Parliament at the time worked with her german colleague peter lisa to implement some reforms. But liza still doesnt like the idea of a government testing agency. As often from government then ive been working on this for a long time and i believe that such an agency would not enhance product safety. But that. Internal emails from the federal Health Ministry stressed the importance of Patient Protection but there are 2 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 mr thats will somehow. Spawn 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. Has declined repeated requests for an interview. Youre going 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 4 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 scene at the new. Busy busy mechanic when you work with machines like i do you need equipment thats been thoroughly tested. For bindo of abode seen how this is the machines that are used are perfectly safe been making last for years even decades did i mention this 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. Of. Little tiny 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 5 bone and the implant device is right about here shove the shaft sits at an angle of about 145 degrees like this. And. They didnt make with micro movements every time you move your leg they hit him a plant rubs against the bone done up the this hole and that causes tiny bits of metal to break off life and. Thats how the stuff in that up in my body. Done in this really good baby you bogey. 8 years ago thoma filed a lawsuit against him appeal 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 simmered the inmate denies that. And. This was the court that was hearing thomas lawsuit asked 2 experts to investigate the situation daniel clues involve from middle mio came to the conclusion that similar mate did not test the implant properly its it when 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 group 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. The scene 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 they dont. Present communion with 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. And auditor whos worked for german sees 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 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 the 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. Especially after the fact and the fact that i prefer not to answer any questions right now that interested me weve received your questions in writing and will provide a response. If i get that as of this line with next kind and we havent received any response i thought you know i have some questions about whether the tests are independent because the manufacturer has pay for this occasion process and i mean how can you guarantee your independence especially when it is thats we follow the process that is. Outlined by the relevant authorities. Our tests are carried out in full accordance with the law before we go just to be in touch to it. And we still havent received a written response from across the agency. More than 700. 00 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 or 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. Divide just evicted i could walk only 500 yards at a time and ive completely lost my sense of taste and smell this can see from one other system there my life just wasnt the same anymore i couldnt work like i used to and i couldnt walk very fast if you were here you can touch us you have to i dont really like to see a court decide that there were flaws in the design and construction of these devices and chiding for. October 15th 2018. A 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. Who caused this group often. Similar b o 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 this is. Syma be a mates attorneys did not attend todays court session. In 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 deal made to pay youre going toma 25000. 00 euros in compensatory damages. But that was just the end of the 1st 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. 40 i think as its given me 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 him would see that the new law doesnt do that it. A distrust of just like this is a sneaked. In 2017 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. Steph 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 2020. 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 52530000000 people who live in the e. U. The country i feel as though i failed for me and i take responsibility for that for the future im ashamed of myself and my colleagues it makes me so mad that i almost want to cry in the. Bonnets accounts helmets being the straw hats be chance fascinators so many choices. In base hat maker. A number of things headgear. And. She creates all kinds of you from your exclusive to the extraordinary. Your romex 30 minutes long double. Stay up to date dont miss our highlights. Program. W dot com highlights. A forester equivalent to 30 suckerfish is cleared every. Hour consumerism is causing a radical depletion of forests. For 25. More classic. Forests and. The tragic reality behind. The exploitation. Starts july 24th double. Live from Berlin Germany commemorates the plot to kill adolf hitler chancellor Angela Merkel leads contributes to the conspirators who tried to assassinate the nazi dictator and overthrow his government 75 years ago today also coming up. Germany and france demand iran release a captured British Oil Tanker in mediately berlin says the seizure of the imperio east a dangerous escalation in the persian gulf region. And tens of thousands