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artificial hips heart fellows instance are all modern medical miracles but what happens when they don't work. you feel like a guinea pig for who could need. it that's made its medical products like hip implants and insulin pumps have to be safe and reliable. but for this week's. 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 we'll explain why. these devices can lead to serious medical complications or even death.

you can see the pain in this man's face he's no longer able to work every day is an ordeal. thomas was because back is full of plastic scrap an artificial disk in his spine has disintegrated into lots of tiny pieces which may have sons 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 flung at some kind of results and he's sitting on a pallet peg one of the pieces slips out back there and that's last month alone a choice. vaska is one of more than one hundred 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 carsten rich along has treated dozens of these patients. they're licensed before who are as or they're in a lot of pain. first of all there's the actual physical discomfort caused by the defective disk and then there's the psychological distress effect because they know they've got this ticking time bomb in their body. but there's no clues to that there's no boost. in two hours of moscow will undergo surgery to remove the plastic scrap. the shop people i'm really nervous but i'm very scared that this just isn't going to work out and the problems will continue to. beamish publish. this is a major operation doctor it along must avoid cutting into vital organs and blood

vessels. that's come to us through the first step is to examine the prosthesis and you can see it there on the screen it's one should. implant i think you should think it's in pretty bad shape. but in. some plastic pieces have become lodged behind his spine. it's yours and i'm pulling out these little bits of white stuff. so it's like pulling out old pieces of chewing gum see. the surgeons place a new artificial disk in vos because back the device is outfitted with titanium plates it's clear that the old prosthesis has severely damaged the vertebrae. these are some absolute disaster this never should have happened. over time the plastic device should have become fully integrated with the surrounding tissue so

that the patient could gradually resume normal activities after surgery. but that didn't happen here. the plastic material started to disintegrate. that probably wouldn't have happened if the disk were made of to cheney i'm. most of those plastic disk was placed in his back at this clinic in the town of leer 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. the implants can be a blessing for many but there are serious problems with these kinds of devices throughout europe. big fights on up to five hundred thousand women worldwide are said to be affected by defective breast implants implant tosses and the implants are made of cheap industrial so a countries called for that but that's i think it's often used to seal windows

affects the good about this and it was some implants have torn and caused cancer and it isn't. 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 roll to bear on to special advisor to the e.u. commissioner for health and food safety she's been calling for more studies and tests for medical devices. vodaphone about soy but i was convinced and i still am that implants and other medical devices are just as a holes and as medicines. so there must be properly regulate it that's a suit to these devices should be subject to strict to quality control measures before they're put on the market floors of tin marked off 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 doesn't know whether he'll ever be able to go back to work . and he's still trying to figure out how this all happened. to settle who's testing these products the law is 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 or in years 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 long is looking through them right now the documents show that there were serious problems with the disks. as among. and how long it's clear from these studies that the implants did not become properly integrated into the spinal system vic's nish or. was it later i noticed similar complications in my patients who've been given these discs the at all but inputs in the bowels who only aplomb. 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. it's not clear whether the clinics chief physicians was informed about the animal tests he declined to talk to us about it. 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 a herniated disc and a doctor recommended and implants. agreed to the surgery even though the disc had not yet been officially approved. the second this couldn't be who i know and i decided to do it there because i was in so much pain and that's and i was ready to do anything to put a stop to it. and i have to go and well an od and the doctor said he could fix it

so i jumped at the chance to go back to town i didn't think about it at all. i'm sorry to say but it turned out to be a huge mistake. and later wasn't going to stay for not that into. a total of twenty nine people signed up for the just surgery. the regulations that govern tests on medical devices are not as strict as those for medicines. 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. must keep books and i was kickboxing back then and after the operation i felt five got i bought a can ignore so i went back to work i didn't think anything could go wrong plus i seen come very close there's a robbery in this interview

a rainier 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 we've done which results in the cboe that you quickly mention. has dramatically exceeded our expectations the patients that we meet in fact of all those who. you know know. just a few months after andrea's wrote his 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. p.s.i.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 company's request.

and the agency did not say whether any doctors had tested the plastic discs. incomplete and for coming. i can't imagine what sorts of people were doing me a valuation but if i'd been called into. insult as a spinal surgeon i would have rejected the application was an issue. and if i'd been personally responsible for making the decision i have turned it down and move. forward. in europe about fifty laboratories are currently testing medical devices in germany these include t u v self. 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 cæsar. they can then be marketed throughout europe. for testing labs are sometimes called appointed authorities the largest such facility in britain is b.s. i. didn't know wishes he'd never taken part in the study. after december twenty eighth and twenty thirteen it's a day that i'll never forget i've had a lot of pain in my life but nothing like the pain i have now never got me. 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 he's sterile now his nerves are damaged and he's physically incapacitated. eventually all i really want is for someone to admit that they made a mistake but that won't happen because people never do that it made them feel a touch. as andreas wrote it recovered from back surgery. doctors at the clinic in lair continued to use the plastic discs. the federal government kept getting reports about serious problems with the devices but for years took no action to stop sales. germany's regulatory system has failed patients like thomas 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 two thousand and fourteen this dutch journalist showed how easy it is to get approval for a medical device in europe. we're designing a device that's not safe at all like a mesh implant that helps to stabilize the uterus we found all the component parts at the supermarket and took some photos of now it's ready to go. and back. similar products are already on the market so the journalists didn't even need to sign up for clinical trials that use human test subject. an estimated ninety

percent of such high risk medical devices don't have to go through clinical trials either. and if it is from people the journalists made an appointment at a c.e. test center in vienna and they filmed the meeting with a hidden camera. often come to work in vain the official doesn't want to see the product itself he'll just rely on the documentation provided by the journalists. or no doctors took part in the process. because. we were little i agree with ninety nine point nine. but says it's not as. if 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 the centuries of poor until fortunately to make sure the devices as approved in a timely manner commend them really before pushing the medical device industry in europe you know provided for over a. million. 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 don't work properly tens of thousands of these devices have had to be replaced . shouldn't they be tested much more carefully because before they come to market

the medical device in newsrooms that is most of foremost can engage in providing obviously. solutions to should be just so 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 europe's 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. drug motorola 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 set of occasion agencies are privately run not government run . health that's led to a kind of business tourism where companies come to europe because they can get says if occasionally pull their products and cheaply to a patient. that's bad enough for a hair dryer or a mix that's when people want those products to be safe so that they don't explode when they use them on 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 distance and. 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. there's been a big increase in recent years in the number of problems with medical devices. in the u.s. the number of reported cases is nearly four million. 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. in the manufacturers keep tight controls on product information. german authorities don't 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 don't and the companies face no penalties. companies such as medtronic have been accused of playing down possible effects with their products. tronic is the world's 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 who's done research on possible conflict of interest in the medical research industry. he's considered an expert on medtronic basically their business model is based on

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 so we started off originally doing was looking at fraud involving these doctors that were getting huge payments said 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 fuse 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 no 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 clare's son glenn quit his job to care for his mother it's very

tough to watch somebody you love going through what they go through it's very tough just being able to walk to just lie 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 don't have the ability to walk anymore your life becomes draw the doll. 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. we're not just talking about trivial things we're talking about patents traffic complications to people of cancer to realty life threatening or whatever but they were not part of the original company sponsored publication

we found that if you added up all the financial association of the authors for individual trials that it was in the millions but one of the lead authors of many of the paper had more than thirty million dollars devices aren't that well understood by the average person so they don't realize the corruption in the device world and how it's actually in many ways worse we used to call the wild wild west it's just an open terrain of just craziness. medtronic denies it try 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. small and i thought that in the us 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 won't 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 out of 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 shoes woman from the north and i can work around what i must at the moment. i heard my husband scream and when i came into the room my son was lying in his father's honest 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. c. happily hits time from i've already gotten used to the fact that i've 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. and mind . the insulin pump is programmed to maximillian specifications. he and his mother check the data regularly because the boy's life depends on a device that functions properly. all the kids in his class know that max suffers from diabetes. his teacher says on of all is trained to deal with emergencies. like the one that happened last june. kept his head from to soak i felt like my blood sugar was low and i was

a little shaky. said thank 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 come our plan 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 i saw that there was something wrong with maxie. everyone else or to maybe there's a problem with his insulin pump. max needed to get sugar into his system right away here the children show what they did to help him. now have something 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 him and now they're not that nice i was pretty scared if i'd had an attack at nice i might have died. max's parents sent the insulin pump to an independent analysis facility it wasn't clear how much insulin ended up in his body and whether the pump or max himself was to blame mr morsi was. good to devise have delivered such a significant dose. you know didn't know much and if the device had met the required specification i say there's no way it would have released that much insulin on its own noids for instance i was on boards for the of. 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 we've mentioned in two thousand and twelve mpg unstrung who is now the federal minister of health told the wonders talk that he supports the system said it's important to protect patients and the interests of the medical device companies. the government has resisted attempts to reform the system. but i don't know is if the germans didn't want to create a new regulation real farsi and they were opposed to additional clinical studies. they said in effect that they didn't need any more experts to. the german government has stuck to these positions in the european parliament. berent a member of the european parliament at the time worked with her german colleague

peter lisa to implement some reforms. but liza still doesn't like the idea of a government testing agency. as often from government then i've been working on this for a long time and i believe that such an agency would not enhance product safety. but that. internal e-mails 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 mr that's 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 doesn't go far enough. and we wanted to find out why he continues to support the use of private companies to test the devices. has declined repeated requests for an interview. you're 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 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 i just know this

it's unbelievable to see at the new. busy mechanic when you work with machines like i do you need equipment that's been thoroughly tested. for bindo of abode seem to have this with the machines that are used are perfectly safe and they can last for years even decades. of mentions but when it comes to medical devices the standards are obviously not as strict would this make if it makes you feel like you're just a guinea pig. the manufacturers. 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 here's my thought on it and the implant device is right about here the shelf the shaft

sits at an angle of about one hundred forty five degrees like this that's eats and sleeps. they didn't leak with micro movements every time you move your leg they hit him a plant rubs against the bone opposite of this hole and that causes tiny bits of metal to break off life and. that's how the stuff ended up in my body. he done in this really going to give the a.b.a. you bogey. eight years ago thoma 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 deal made denies that. and. this the court that was hearing thomas lawsuit asked two experts to investigate the situation daniel clues and vole from middle myo came to the conclusion that similar

mate did not test the implant properly it's 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 market and . 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. we. presume 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 who's 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 don't have the expertise to make qualified judgments. none of them is really into pendent 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 and if they're 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 he's a vice president at t u v south which is germany's 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 if i kind of i prefer not to answer any questions right now but interested we've received your questions in writing and will provide a written response. if that as a bit long we're going to spend on we haven't received any response i thought you

know i have some questions about whether the tests are independent because the manufacturer is pay for the city because from process. how can you guarantee your independence especially when two sets we follow the process that is. outlined by the relevant authorities and then our tests are carried out in full accordance with the law before going to protest against such data is made up. and we still haven't received a written response from presidency. more than seven hundred patients including you're 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 me completely i could walk only five hundred yards at

a time and i've completely lost my sense of taste and smell this instant from the other sister there my life just wasn't the same anymore but i couldn't work like i used to and i couldn't walk very fast. i didn't 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. a regional court in the city of fribourg is to announce its verdict today. you're going told the hopes that the court will rule in favor of the plaintiffs. because the group offered. to him a deal 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. tim of you mates attorneys did not attend today's court session. the presiding judge says that the company's hip implants should never have been approved for sale he adds that the risks posed by the devices were well known and more tests should have been carried out. the judge ordered sim of the inmate to pay you're going toma twenty five thousand euros in compensatory damages. but that was just the end of the first round. will certainly appeal the judge's ruling. they continue to claim that their hip implants are not defective. this case could take years to resolve.

meanwhile dogma ruled parent has abandoned her effort to create a government agency that would impose stricter controls on medical device testing. voiding i think is it's 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 told simply to see that the new law doesn't do that it. a distrust of just like this is a slipped. 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. a sponsor staff tells us that the ministry is committed to

patient safety but it's not always possible to conduct extensive tests on some medical devices. that means that private testing facilities will continue to be used. 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 isn't enough it still makes me angry enough to. look to see if it's like a wound that won't heal this month and i'm upset that we weren't 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 on them and i take responsibility for that for the future i'm ashamed of myself and my colleagues it makes me so mad that i almost

want to cry in the. can africa. good security. look at that. and didn't hear it could go in. the canteen guides coffee makes some and environmental projects with sustainable energy. doesn't look. good. in thirty minutes w. .

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