as now i want to meet those woman back home who are bones by their duties and social norms and inform them about that basic rights my name is them out of the homes and i wore them. artificial hips hard films instants are all modern medical miracles but what happens when they don't work. you feel like a guinea pig for who couldn't. get to some of the medical products like implants and insulin pumps have to be safe and

reliable. but 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 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. almost was because. the back is full of plastic scrap and artificial

disk in his spine has disintegrated into lots of tiny pieces which may have sins and the pain is the worst when i lie down like when i go to bed at night the slums just ask my wife because of that some kind of results and he's sitting on a pallet keg one of the pieces slips out back then and that's the last month. the last is one of more than one hundred patients who were given a defective artificial disk surgeons at this clinic there braman specialize in removing the plastic pieces that have come loose. dr carsten rich along has treated dozens of these patients. who are there in a lot of pain and look 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 truth to

that. in two hours vaska will undergo surgery to remove the plastic scrap. the people know i'm really nervous i'm very scared that this just isn't going to work out and the problems will continue it. this is a major operation dr richard must avoid cutting into vital organs and blood vessels . that's come to us through the first step is to examine the prosthesis so you can see it there on the screen it's one should there in front of me it's in pretty bad shape. but. some plastic pieces have become lodged behind his spine. is and i'm pulling off

these little bits of white stuff. so it's 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 it's clear that the old prosthesis has severely damaged the vertebrae. is also an absolute disaster just never should have happened this year. 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 because plastic disk was placed in his back at this clinic in the town of blair 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. they fight so i have to fight. 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 country's record for the us i guess but it's often used to seal windows offense the good baptist 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 ruled parent is

a special advisor to the e.u. commissioner for health and food safety she's been calling for more studies and tests for medical devices. vada 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 that's assuming these devices should be subject to strict to quality control measures before they're put on the market force 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 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. fair test

who is testing these products with 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 rainier 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. dr long is looking through them right now the documents showed that there were serious problems with the disks.

it's clear from these studies that the implants did not become properly integrated into the spinal system vic's nish or. later i noticed similar complications in my patients who've been given these discs but you know what inputs and. tom. but the company apparently ignored these results despite the warning signs. brainier no needed to carry out a series of clinical tests on humans some of those tests were conducted here with 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. and restored it 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 has come in and i decided to do it there because i was in so much pain schmidt's and i was ready to do anything just put a stop to it. and i stood up and when an od and the doctor said he could fix it so i jumped at the chance to get i stood up i didn't think about it at all. i'm sorry to say but it turned out to be a huge mistake. glad i wasn't going to stay for. that of. 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. i was kickboxing back then and after the operation i felt five got i bought a can again or 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 it clinical study which headline study that we've done which results in the cboe as you mention. has dramatically exceeded our expectations the patients that we've been privileged to meet in fact of all those who also you know know. just

a few months after 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. in concluding for the commies and shut snow i can't imagine what sorts of people were doing me a valuation but if i'd been called into. consult as a spinal surgeon i would have rejected the application. in issue. and if i'd been personally responsible for making the decision i have turned it down.

before. in europe about fifty laboratories are currently testing medical devices in germany these include t u v self t u v rhineland and. these facilities award c e certifications for things like heart pacemakers syringes and artificial hip joints most of the labs do not employ doctors. manufacturers of medical devices can choose the facility they prefer and they pay for the certification process. if a medical device passes the tests and receives the 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. . under a us rodent now wishes he'd never taken part in the study.

after december twenty eighth and twenty second 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. 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 he's sterile now his nerves are damaged and he's physically incapacitated. all i really want is for someone to admit that they made a mistake this video but that won't happen because people never do that they've been taught. 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 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 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 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 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 will agree with ninety nine point nine. but says it's not as. if there is. no what's yours. one of 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 approach unity to make sure the bronson's was approved in a timely manner to manage them really before production the medical device industry in europe you know provides an overhaul. of new 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 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 his freezer is most of foremost conclusion providing obviously you should or should be should interested from i'm a nurse. 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 to bars.

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 bare and says europe should have a state agency to approve medical devices. just like the one that approves medicines independent experts and medical advisors. the problem is that the certification agencies are privately run not government run . that's led to a kind of business tourism where companies come to europe because they can get certification for their products and cheaply. that's bad enough for a hair dryer or a mix. when. people want those products to be safe so that they don't explode when they use them. but what about medical products that are placed

inside your body. 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. as well 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. 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 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 defects 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 upon them giving money to doctors today those doctors and to put devices in people or try and sell their device to other doctors what we started off originally doing was looking at fraud involving these doctors that were getting huge payments 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 you even fuse 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 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 use 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 very tough just be able to all. to just lie 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 wall anymore your life becomes sirah the doll.

stephanie claire had no idea of the risks posed by infuse investigations later revealed 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 catastrophic complications to people of cancer to realty life threatening or whatever but it's very we're not part of the original company sponsored publication and we found that if you added up all the financial association of the authors for individual trials that it was 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 crazy. 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 his company video promotes the product advantages. take time that. was certainly. does not mean. 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 a sort of i walked 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. but 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 the 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 he had time from i've already gotten used to the fact that i've got to carry this thing around all day. as this 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. like.

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 yet. his teacher who says on of all is trained to deal with emergencies. like the one that happened last june. head into two o'clock felt like my blood sugar was low and i was a little shaky. said thank you when i called my mom to tell her about it. and she asked me what the reading on the pump us. i said eight point eight kilometers and she said what's wrong yes. the pump had released a huge dose of insulin by mistake and that could have been deadly for max. chad thank you ok man i saw that there was something wrong with maxie. everyone

else with two maybe there's 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. now that i have 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 him and now they're not 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 the device have delivered such

a significant dose. and the didn't know much and if the device has met the required specification i say there's no way it would have released that much insulin on its own. for instance i was on board this flight even though. 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 m.p.'s sean who is now the federal minister of health told the oldest talk that he supports the system shawn 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 example. is it 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 anymore experts to. the german government has stuck to these positions in the european parliament. behrendt 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 in 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 except. it's of

cæsar the few cation. 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 that's we are somehow. on 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. spawn 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'm slow because it's unbelievable the need. because even in the mechanic when you work with machines like i do you need equipment that's been thoroughly tested. to be new of abode seen how this or the machines that are used are perfectly safe and have been making last for years even decades didn't mention this but when it comes to medical devices the standards are obviously not as strict when this rig it makes you feel

like you're just a guinea pig for the manufacturers. of. little tanian hip 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 nic when i heard about that process called micro movement i knew something was wrong if you shit over saying here's my thought bone and the implant device is right about here. the shaft sits at an angle of about one hundred forty five degrees like this says you can see. they didn't meet with micro movements every time you move your leg they hit him a plant rubs against the bone up with this hole and that causes tiny bits of metal to break off life and. that's how the stuff ended up in my body. done in this really going to give baby your body. 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 claim that the company knew there were problems with the implants similar deal made denies that. this was the court that was hearing thomas lawsuit asked two experts to investigate the situation daniel clues involve from middle myo came to the conclusion that similar mate did not test the implant properly it's between two thousand feet but the company had still managed to qualify for c.e. certification by submitting old tests that involved a similar device. goodness me the movie 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 it i

couldn't be sure 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. very. present communion with these problems have 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 whose work for german c.s. 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 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. over. the auditor says that companies have a lot of influence over the agency 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 team uva. should not be a trip that's what kind of fact i prefer not to answer any questions right now but interesting we've received your questions in writing and will provide a written response. if you think that as of this line we're going to spend and we haven't received any response i phone and i have some questions about whether the test independent because the manufacturer is pay for this education process and how can you guarantee your independence especially because that's we follow the process that is outlined by the relevant authorities. our tests are carried out in full accordance with the law before going to protest against such data is made. and we still haven't received a written response from. 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 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 five hundred yards at a time and i've completely lost my sense of taste and smell this instant from one other sister vicki my life just wasn't the same anymore i couldn't work like i used to and i couldn't walk very fast if you were here you can touch us you have to i don't really like to see a court decide that there were flaws in the design and construction of these devices and try doing four. hundred.

october fifteenth twenty eighteen. a regional court in the city of fribourg is to announce its verdict today. you're going toma hopes that the court will rule in favor of the plaintiffs. cause the group often. tim a 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. to. i'm a be a mate's 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 similar view made 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. while dogma ruled parent has abandoned her effort to create a government agency that would impose stricter controls on medical device testing. forty i think that's cable 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 put it in but the new law doesn't do that it. but this was

don't just look this is a slate. in twenty seventeen the e.u. approved new regulations on medical devices they include more clinical studies more controls on products and an independent database but they did not address the basic problem there are still no independent tests on the devices. this is a diabetes charity event in berlin sponsored in part by medtronic health minister yen spawn is here. sponsor staff tells us that the ministry is committed to patient safety but 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 all. of us it's like a wound that won't heal that's money 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 and i take responsibility for that for the i'm ashamed of myself and my colleagues it makes me so mad that i almost want to cry. for.

fresh vegetables grown with less water less space. and no pesticides. hydroponic farming in mumbai. but on these green is really healthy what about the costs and can farmers afford the equipment. d.w. . be in good shape. cigarettes

the latest trend but the long term health of facts on still i. mean disposed towards you could call it the biggest field study that's taking place in the health sector worldwide and. we ask the expert. on d w. i think it's everything challenging first on how to make a muslim. school much different culture between here and there challenging for him to. do some business i think it was worth it for me to come to germany.

got my license to work as a swimming instructor to shine our two children one hundred votes just one of those toughest. what's your story take part sharon on in full migrants caught next. u.s. president donald trump has confirmed that homeland security secretary kirsten nelson is leaving her position it wasn't immediately clear whether her decision was voluntary nelson oversaw trump's controversial policy of separating migrant children from their parents at the mexican border she defended the president's declaration of a national emergency to build a border wall. former israeli army general and centrist party leader benny gantz has criticised.