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 likeHeart 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 Doct