the european parliament later today. up next how did the banana become a global export products a 2 hour documentary on bananas and the public's forget more news coming up at the top of the hour i'm sara kelly in berlin thanks for watching cricket. or 1st climbing much of. doors grandma is arrives. join your regular jane on her journey back to freedom. you know work interactive documentary . and the regular season returns home on d w don't come tanks.

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 the some of the medical products like hip implants and insulin pumps have to be safe and reliable and. this was said. in europe alone medical devices generate 100000000000 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 and artificial disk in his spine has disintegrated into lots of tiny pieces and manson's and the pain is the worst when i lie down like when i go to bed at night the flumes just ask my wife becoming one of all functions that some kind of results and he's sitting on a pallet keg one of the pieces slips out back there and that's last month when a choice. lost 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 carsten written a long history to dozens of these patients. that i can still fall who are close or they're in a lot of pain and look 1st of all there's the actual physical discomfort caused by the defective disk and then there's the psychological distress to fix it because they know they've got this ticking time bomb in their body. but there's not too much to that there's no food. in 2 hours waskow will undergo surgery to remove the plastic scrap. the shop i'm really nervous because i'm very scared that this just isn't going to work out and the problems will continue it. beamish publish. this is a major operation doctor it along must avoid cutting into vital organs and blood

vessels. it's contest the 1st step is to examine the prosthesis so you can see it there on the screen it's one should. implant i think you should because it's in pretty bad shape. with. some plastic pieces have become lodged behind his spine. isn't aren't 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. 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 didn't happen here. the plastic material started to disintegrate. and that probably wouldn't have happened if the disk were made of to cheney i'm. most of those plastic disc was placed on 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. the implants can be a blessing for many but there are serious problems with these kinds of devices throughout your. big fight so i have to. $500000.00 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 the us i think it's often used to seal windows offense to

get that just a nickel some implants have torn and cause cancer and it isn't. 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 rolled 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 a sick to these devices should be subject to strict to quality control measures before they're put on the market before as often 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. fair to set off who's 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 rainier was one of thousands of small businesses in europe that were trying to break into the medical devices market. about 10 years ago started testing plastic disks and

baboons. after several months the animals were euthanized and autopsies were carried out. the results of the autopsies were later leaked by whistleblower. dr rhee said lung is looking through them right now the documents showed that there were serious problems with the disks. as among. it's clear from the studies that the implants did not become properly integrated into the spinal system of its initial all. later i noticed similar complications in my patients who've been given these discs should be at all but inputs and only update. 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 at pro spine facility in southern bavaria. it's not clear whether the clinics she physicians was informed about the animal test he declined to talk to us about it. grassroot 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 2010 he was suffering from herniated disc and a doctor recommended an implant. to agreed to the surgery even though the disc had not yet been officially approved. the 2nd is couldn't be who i know i decided to do it because i was in so much pain schmidt's and i was ready to do anything to put a stop to it. and i stood up and well an od and the doctor said he could fix it so

i jumped at the chance the good i should have done i didn't think about it at all. i'm sorry to say but it turned out to be a huge mistake led light of others to going to stay for not that into. a total of $29.00 people signed up for the disc surgery. the regulations that govern tests on medical devices are not as strict as those for medicines. and 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 that i buy the kennedy now so i went back to work i didn't think anything could go wrong plus seemed very pleased there's a robbery in this interview

a rainier sales manager touts the positive results of the test on people like andreas would. want to be seen in your clinical studies today well this is where we want everybody to go quite excited actually because the clinical study which headline study that we've done which results in the siebel as you call dimension. has dramatically exceeded our expectations the patients that we've been privileged to meet in fact of all who was you know know. just a few months after andreas 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. 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 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 disks. concluded for coming. 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 isn't an issue. and if i'd been personally responsible for making the decision i've turned it down. we couldn't afford it. 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 cæsar if 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. wrote it now wishes he'd never taken part in the study. after inform 6 december 28th and 24 teen 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. even trying to move 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 didn't feel up to it. 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. germany's regulatory system has failed patients like thomas. 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. 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 it 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 90 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 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 99.9. there is. says it's not as. it's there is there are. 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 approach and the fortunate to make sure the devices as approved in a timely manner to manage them really before the medical device industry in europe you know provides over. a 1000000 of medical 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 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. their version of truth that is most of foremost conversion providing obviously you should or should be should be trusted from unfair 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. 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. and what was never. blame hobbit is

a problem is that the certification 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 set if occasionally pull their products quickly and cheaply a patient on their own until the. 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 and 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. if. 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 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 don't have any idea how

many devices are actually on the markets. the companies are required by law to report problems that may damage patient's 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 $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. cofactor 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 the people or try and sell their device to other doctors but 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 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 pain 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 be able to walk 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 walk anymore your life becomes 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 we're talking about catastrophic complications to people of cancer to really be 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 but individual trials that it was in the millions. one of the lead authors of many of the papers had more than $30000000.00 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 it the wild wild west it's just an open terrain of just craziness. medtronic denies it tried to minimize the risks of infuse it does say that its employees sometimes proposed changes to research articles about the product. the company continues to reject allegations that it offered bribes or engaged in other improper behavior in any case medtronic has now revised its policies. medtronic is

a leading manufacturer of insulin pumps his company video promotes the product advantages. taking time that. was settled. in the us a similar pump has been approved but children who use it must be at least 14 in europe the age limit is much lower. than many parents insulin pumps mean they 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 onto the market for 4 decades now. but research data from the us indicates that no other medical device causes more serious health incidents.

i went upstairs and i could hear that walk up the stairs i can hear breathing and sure enough whenever i went in the room she was my shoes from in from the north and i can work out 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 1000000 cruise use is 10 years old. ready he was diagnosed with diabetes at the

age of 2. 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 my. the insulin pump is program 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 teachers design of all is trained to deal with emergencies. like the one that happened last june.

kept his head from to talk like 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 8.8 kilometers and she said was right yes. the pump had released a huge dose of insulin by mistake and that could have been deadly for max. chad and for all come back i saw that there was something wrong with maxie. everyone else saw it too 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 have to be like his hands were really cold we thought he had gone into diabetic shock so we called the emergency doctor for. max recovered but the

incident left him shaken he was concerned about his health finding and now 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 someone who was. good the device have delivered such a significant dose. you know didn't know much and if the device has met the required specifications there's no way it would have released that much insulin on its own nods for instance i was in borders for i didn't move. we asked my tronic 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 2012 mpg unspun who is now the federal minister of health told the bonus 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 pharmacy and they were opposed to additional clinical studies . they said in effect that they didn't need anymore experts in. the german government has stuck to these positions in the european parliament. right there aren't 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 thought that. internal e-mails from the federal health ministry stressed the importance of patient protection but there are 2 other goals. established except. sense of c.e. certification. and faster market access. starship and so 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. japan has declined repeated requests for an interview. during thoma is a technical manager at a wine cellar several years ago he had hip replacement surgery. the device included component parts made of titanium. but 4 years later the implants had to be removed . suspected that the device had not been properly tested. so he filed a lawsuit against the manufacturer. to me because i'm too slow because

it's unbelievable. busy vincy the mechanic when you work with machines like i do you need equipment that's been thoroughly tested. for bindo of abode seen on the machines that are used are perfectly safe and they can last for years even decades. of making 50 but when it comes to medical devices the standards are obviously not as strict when it makes you feel like you're just. guinea pig for the manufacturers for the hashtag. led to 20 m. 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 nick when i heard about that process called micro movement i knew something was wrong if you should over saying here's my 5 bone and the implant device is right about here. the

shaft sits at an angle of about $145.00 degrees like this. and. 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 good to get baby you bogey. 8 years ago told me i 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 the inmate denies that. and. the court that was hearing thomas lawsuit asked 2 experts to investigate the situation daniel clues and vall from middle myo came to the conclusion that similar

mate did not test the implant properly because it's between 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 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. as in communion with these problems had been outlined in various research publications as early as 2003

so the situation was well known. but at that time hip implants were not considered especially risky so the testing process was not terribly challenging. and auditor whose work for german c certification agencies for 10 years agreed to talk to us on condition of anonymity. he had serious concerns about how the quality control tests were carried out on various products. one of the problems is that many of the auditors are freelancers and simply don't have the expertise to make qualified judgments. none of them is really independent they almost never decide that a product is risky. and 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 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 a trip at the time the fact that i prefer not to answer any questions right now but interesting that we've received your questions in writing and will provide a written response. if that as a bit long we're going to spend and we haven't received any response i found that i

have some questions about whether the test independent because the manufacturer is pay for this education process and i mean how can you guarantee your independence especially when 2 sets we follow the process that is outlined by the relevant authorities when our tests are carried out in full accordance with the law before going to be with us again because that story is made up. and we still haven't received a written response from across the agency. more than $700.00 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 a big. could walk only 500 yards at

a time and i've completely lost my sense of taste and smell has been slit from the room unassisted my life just wasn't the same anymore but 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'd really like to see a court decide that there were flaws in the design and construction of these devices and try to inform. october 15th 2018. 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. their own cause the group often. similar below 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 a. similar view mates attorneys did not attend today's court session. the presiding judge says that the company's hip implants should never have been a clue. for sale he adds that the risks posed by the devices were well known and more tests should have been carried out. the judge ordered similar deal made to pay you're going toma $25000.00 euros in compensatory damages. but that was just the end of the 1st 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. 40 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 but simply to put it in but the new law doesn't do that it. a distrust of just like this is a sneaked. in 2017 the e.u. approved new regulations on medical devices they include more clinical studies more controls on products and an independent database but they did not address the basic problem there are still no independent tests on the devices. this is a diabetes charity event in berlin sponsored in part by medtronic health minister yen spawn is here. sponsored 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. by. the regulations are due to go into effect in 2020. the medical device industry is now lobbying for a longer transitional period. this is a stylish this isn't enough it's still makes me angry off to all these years. 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 52530000000 people who live in the e.u. the. i feel as though i failed for me 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

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this is. beauty is coming to you live from berlin germany is enough on the line makes hell finally reach for the european union stop. we are you on the inside no body will to fight us from the outside. the bench.