and the. city in ruins morale when a. symbol of a long conflict in the philippines. between the muslims and the christian population. structures occupied the city center in two thousand and seven team president to church's response was told. by the federal reserve will never gain political gain of. the reconquest turned into tragedy this is not the kind of freedom that we want. how did morality become a gateway to islamist terror. an exclusive report from a destroyed city. in the science of bias starts april eleventh on d w.

artificial hips hard fellows instance are all modern medical miracles but what happens when they don't work. you feel like a guinea pig for who can eat. it that's made its medical products like hiv implants and insulin pumps have to be safe and reliable in full. and for listeners. in europe alone medical devices generate one hundred billion euros in turn over every year. but this system is out of control and in this report 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 disc 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 it's the flumes just ask my wife because in one of its own quantities also he's sitting on a pallet keg one of the pieces slips out back there and that's us can't. vaska is one of more than one hundred patients who were given a defective artificial disc surgeons at this clinic there braman specialize in

removing the plastic pieces that have come loose. your dr carson written long has treated dozens of these patients. that are still four who are there in a lot of pain and stroke 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 not too much to that there's no boost. in two hours of oscar will undergo surgery to remove the plastic scrap. the shop people i'm really nervous i'm very scared that this just isn't going to work out and the problems will continue it. binny's publish. this is a major operation dr ritalin must avoid cutting into vital organs and blood vessels

. it's contest from the first step is to examine the prosthesis so you can see it there on the screen it's one should there implant i think you should think it's in pretty bad shape so put. this in. some plastic pieces have become a large behind his spine. is in time of 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 bosco's back the device is outfitted with tanian plates it's clear that the old prosthesis has severely damaged the vertebrae. these are some absolute disaster 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 disc or made of to tainio . plastic disk was placed on his back at this clinic in the town of lear in northwestern germany. one hundred thirteen other patients had similar operations here and two thirds of them later had to undergo major surgery to correct serious complications. 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 country's confident but as i get it's often used to seal windows or affects the

good doctor just a nickel some implants have torn and cause 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 important as medicines. so they must be properly regulated that's just a tool these devices should be subject to strict a quality control measures before they're put on the market the force of the

unmarked stuff and. but rod bearings 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. who is testing these products for the lord not experts apparently on. the history of artificial spinal disks highlights the deficiencies in the european product approval system. this is the former headquarters of rainier technology in cambridge england the company used to make plastic spinal implants brain year 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 a month. and having to pay it's clear from the studies that the implants did not become properly integrated into the spinal system of extinguished all. later i noticed similar complications in my patients who've been given these discs but you know what inputs in the bowels only of tom. but the company apparently ignored these results despite the warning signs. no.

brainier now needed to carry out a series of clinical tests on humans some of those tests were conducted here at the pro spine facility in southern but the area. it's not clear whether the clinics chief position 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 herniated disc and a doctor recommended any plans. to agreed to the surgery even though the disc had not yet been officially approved. the second this 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 just 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 i should have done i didn't think about it at all they got me i'm sorry to say but it turned out to be a huge mistake was flat out lied about distinguished if 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. 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 by the kennedy know 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 is something the seed of which you quickly mention. has dramatically exceeded our expectations the patients that we've been privileged to meet in fact of all those who 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. 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. insult as a spinal surgeon i would have rejected the application. and issue. and if i'd been personally responsible for making the decision i have turned it down. it kind of forked. 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 the cation it can then be marketed throughout europe. the testing labs are sometimes called appointed authorities the largest such facility in britain is b.s. i. didn't know wishes he'd never taken part in the study. after december twenty eighth and twenty for 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 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. all i really want is for someone to admit that they made a mistake but that won't happen because people never do that. they can 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. but. we're designing a device that's not safe at all and mesh implant that helps to stabilize the uterus we found all the component parts at the supermarket and took some photos now it's ready to go to court. 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 was funky the journalists made an appointment at a c.e. test center in vienna and they filmed the meeting with a hidden camera to the. bank often come to work in vain the official 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. says it's not. it's there it's there are road know what's yours. 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 of the century's approach and soon a new approach unity to make sure the bronson's as approved in a timely manner to manage them really before british or the medical device industry in europe you know provides over a. million new devices that are 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.

their version is true so it is most of foremost conclusion providing obviously your solutions to pretty sure interests are different and and worse. in the us much stricter regulations apply a government agency the food and drug administration monitors the approval process for medical devices some politicians have criticised europe's approach to bodies. 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 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 says if occasionally pull their products and cheaply to the person on their own and to this mosquito 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 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 and it's disastrous 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 a 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 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 conflicts 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 to. those doctors and to put devices that people are trying to sell their device to other doctors that we started off originally doing was looking at fraud involving these doctors that were getting huge payments sent 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 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 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 bell. 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 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 for individual trials that it was a million dollars one of the lead authors of many of the papers 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 that'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. and 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 products advantages. that. was. dismantled. in the u.s. 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 onto 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 can hear assume i 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. 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 arms 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. time from already gotten used to the fact that i've got to carry this thing around all day. is the chip it runs back here and connects to a catheter. and the device squirts insulin through the chip into my body. 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 who says on of all is trained to deal with emergencies. like the one that happened last june . headhunter took i felt like my blood sugar was low and i was

a little shaky. said tyke 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 what's. the pump had released a huge dose of insulin by mistake and that could have been deadly for max. and for alchemy i saw that there was something wrong with maxie. everyone else with too 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 caption to make 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 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 if the device had met the required specification and there's no way it would have released that much insulin on its own. it's for and since i was born as for i didn't know from. 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 bonus 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. by example. is if the germans didn't want to create a new regulation real farsi and they were opposed to additional clinical study as. they said in effect that they didn't need any more experts in. the german government has stuck to these positions in the european parliament. i talked to bear and 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 acceptance of see. certification. and faster market access. starship instant had some guy 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. spawn 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 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. 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. how this is the machines that are used are perfectly safe been making last for years even decades did i mention this 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 manufacturer's. litany of 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 five bone and the implant device is right about here shove the shaft sits at an

angle of about one hundred forty five 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 heat 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 give baby you bogey. eight years ago told me i filed a lawsuit against similar b.-o. mate 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 denies that. and. 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 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. cricket 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 bob good and. when they were that. the investigators determined that the hip device was defective because it rubbed up against the surrounding moen structure that problem should have been identified through proper testing the health risks had already been widely reported. present communion with these problems had been outlined in various research publications as early as two thousand and three so the situation was well known. in this. 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 seeing the 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. 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 to africa and the fact that i prefer not to answer any questions right now but interested we've received your questions in writing and will provide a written response but it's not that bad as of this line we're going to spend and we haven't received any response so far i have some questions about whether the

tests are independent because the manufacturers pay for the city cation process has to be 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 be with us again because that state is made up. and we still haven't received a written response from across agency. more than seven hundred patients including you're going toma receive defective hip replacement implants many of those people have no organized a support group. some of them. filed suit against the manufacturer similar. the legal proceedings have dragged on for several years. 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 has been slit from the room unassisted 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 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 charging for in. october fifteenth twenty eighteen. a regional court in the city of fribourg is to announce its verdict today. you're going to hold the hopes that the court will rule in favor of the plaintiffs. who go through all the groups often. to my view 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 sippin plants 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 deal made to pay you're going toma twenty five. i 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. forty i think as 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 and told simply to see that the new law doesn't do that it. a distrust of just like this is a sneaked. 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. on the response 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 two thousand and twenty. the medical device industry is now lobbying for a longer transitional period. this is a stylish the system of the few it 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 five hundred twenty five hundred thirty million people who live in the e.u. the country i feel as though i failed 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. song choice.

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