Shirts are going up paul. Has mastered on to he took part in the greatest adventure in history. Neil armstrong was his destiny starts july 20th on t. W. 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 the some of the medical products like hip implants and Insulin Pumps have to be safe and reliable for zahir and for listeners. In europe alone
medical devices generate 100000000000 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. His back is full of plastic strips and artificial
disk in his spine has disintegrated into lots of tiny pieces he may have sins and the pain is the worst when i lie down like when i go to bed at night is the slums just ask my wife and mother fall flung at some kind of hes also hes sitting on a pallet keg one of the pieces slips out back there and thats us i cant make choices. Is one of more than 100 patients who were given a defective Artificial Disc Surgeons at this clinic there braman specialize in removing the plastic pieces that have come loose. Dr Kirsten Ritter long has treated dozens of these patients. That are in school for 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 effect because they know theyve got this ticking time bomb in their body. But its not used to that. In 2 hours of oscar will undergo surgery to remove the plastic scrap. The shop 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 dr rhee to learn must avoid cutting into vital organs and blood vessels. Thats come to us through the 1st step is to examine the prosthesis you can see it there on the screen its the one should be on the implant i think you should because its in pretty bad shape. With. Some plastic pieces have become lodged behind his spine. And im pulling out these little bits of white stuff. So its like pulling out old pieces of chewing gum so if. The surgeons place a new Artificial Disc in votes because beck the device is outfitted with Titanium Plates its clear that the old prosthesis has severely damaged the vertebrae. Is also an absolute disaster this never should have happened here. 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 disk were made of to tainio. Because plastic disk was placed in his back at this clinic in the town of leer 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. Implants can be a blessing for many but there are Serious Problems with these kinds of devices throughout your. Bedside so i have to. 500000. 00 women worldwide are said to be affected by defective Breast Implants implant tosses and the implants are made of cheap industrial silicon valleys called for that but thats i think that 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 roll to bear on to
special advisor to the e. U. Commissioner for health and food safety shes been calling for more studies and tests for medical devices. Via the funny but soit 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 just a tool these devices should be subject to strict a 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 off whos testing these products 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 Brainier 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 discs 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. Dr Richard Allen is looking through them right now the documents showed that there were Serious Problems with the disks. As among. Its clear from the studies that the implants did not become properly integrated into the spinal system vics nish to all. Later i noticed similar complications in my patients whove been given these discs be at all but inputs and. Tom. But the company apparently ignored these results despite the warning signs. You know. Brainier 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 tests he declined to talk to us about it. Andreas role 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 a 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 i stood up and well an Optimist Doctor said he could fix it so i jumped at the chance to go to town i didnt think about it at all they got me im sorry to say but it turned out to be a huge mistake fleda glad i wasnt going to stick it out that the. 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 from medicines. 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 was kickboxing back then and after the operation i felt 5 god i bet i can ignore so i went back to work i didnt think anything could go wrong plus a scene very much theres a robbery in this interview a raynier Sales Manager touts the positive results of the test on people like andrea. What have you seen in your clinical studies today well this is where we want everybody to go quite excited actually because the Clinical Study which Headline Study that weve done which results in the c. As you call dimension. Has dramatically exceeded our expectations the patients that weve been privileged to meet in fact of all 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 discs. Completed for the commies and shots now i cant imagine why. Sorts of people were doing the evaluation but if id been called in to consult as a spinal surgeon i would have rejected the application. And issue. And if id been personally responsible for making the decision ive turned it down. We
couldnt afford. 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. 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. After December 28th and 27 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 got me. Would 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 but that wont happen because people never do that theyve been feeling 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 layer declined comment for this report to. 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 in plant that helps to stabilize the uterus we found all the Component Parts at the supermarket and took some photos of now its ready to go. And back. Similar products are already on the market so the journalists didnt even need to sign up for Clinical Trials that use human test subject. An estimated 90 percent of such high risk medical devices dont have to go through Clinical Trials either. And if it is funky the journalists made an appointment at a c. E. Test center in vienna and they filmed the meeting with a hidden camera to the. Bank 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 99. 9. But says its not. Its there is there are road know whats yours. Why the. T u v austria now says that in this case Important Documents were not submitted to a. 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 the centuries of poor and the fortunate to make sure the good bronsons as approved in a timely manner to manage them really before british and the medical Device Industry in europe are provided with over a. 1000000 new devices that are designed to. Help
one provide solution true or 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 is through the centers most of foremost conclusion providing obviously youre. Pretty sure interests are different 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 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 no role at bayer and says europe should have a state agency to approve medical devices. Just like the one that approves medicine speak with independent experts and medical advisors. What was never. Blame hobbit is a 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 certification for their products closely and cheaply to the patient 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 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 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 u. S. 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. He 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 markets. 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 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. Called thacher 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 on them giving money to Doctors Today and those doctors that put devices that people or try sell their device to other doctors we started off originally doing was looking at fraud involving these doctors that were getting huge payments to them we have actually then started learning about this product called infuse have you had Spine Fusion Surgery since 2002 you even fuse was used as a bone graft material there were allegations that the product caused dangerous side
effects the lawsuits started piling up people in 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