tv The Great Implant Scandal - Panorama BBC News November 30, 2018 3:30am-4:01am GMT
now on bbc news, time for panorama. tonight on panorama, the implants that put patients at risk. it's really important to know whether these devices are safe or not. millions of people in the uk have a medical device inside them. would you want that going inside your child? no. but these products aren't always adequately tested. i couldn't believe it. i'm frightened that this can happen and i'd no idea. we reveal how potentially dangerous devices get into our bodies. why did the mhra allow that to go into humans? we can't talk about decisions that were taken. and how our secretive system of regulation fails to protect patients. there are risks,
you have to tell people. you can't withhold that. that's immoral, unethical and illegal in my mind. medical devices can transform our lives. medical devices can transform our lives. they keep us walking, they keep us breathing and they keep our hearts beating. the medical device industry has helped transform the lives of millions of people. and it's a global industry worth billions. more than two million people in the uk are thought to have some type of implant. thousands of companies are trying to sell the latest gadget. what they won't necessarily tell you is that "new" doesn't always mean safer, or better. or that some devices might
actually damage your health. panorama has been investigating the industry with the international consortium of investigativejournalists, the guardian newspaper, and medical journal the bmj. medical devices don't have to be tested as rigorously as drugs. and some evidence about their safety and effectiveness is kept hidden from doctors and patients. let's look at the evidence, the claims that are being made by different clinics. it's a subject i know well. i have been researching medical devices for almost a decade. now i am often invited to medical conferences to talk
about the problems they can cause. i mean look at these headlines. this is just from the last couple of months. "patients crippled by artificial metal hips." johnson &johnson to pay 4 million. it's an industry where commercial interests often seem to outweigh the interests of patients. take this new type of pacemaker. the nanostim sits inside the heart. it's an american invention, but was never approved for general use on patients there. unlike in europe. you thread this small capsule through the vein in the leg up into the heart and it doesn't involve any stitches or surgery. so here we go, look that's where you've got it, maureen. in 2014, maureen mccleave became the first woman in the uk to have the pacemaker fitted. i was really over the moon but i felt a bit like a guinea pig because i was gonna be the first one but a good guinea pig and i was grateful
that i'd been chosen, because it sounded too good to be true. three years after her operation, the battery in maureen's pacemaker stopped working. but the doctors couldn't get it out. maureen now has a traditional pacemaker keeping her alive. but the nanostim is still sitting inside her heart. i don't like the thought i've got a piece of metal or whatever in my heart that's doing nothing, and it's just laying there. disappointment you know. to have it done and then have to go through all that. the manufacturers say they "met all regulatory requirements" and the pacemaker was "approved based on strong performance and safety data." 1,400 patients had the nanostim.
but implants were stopped for safety reasons. batteries failed and parts fell off inside patients. at least three people died. so how can that happen? how can a device that doesn't work properly be used on so many patients? and why was a device that was made by an american company first used on british patients? the simple answer is that it's been easy to get new medical devices approved in europe, so american companies often launch new products here. well, they do it because they know the system's more lax. they know they can get approval quicker. they know they can get access to all of the market across europe and get out there quicker and experiment and then take it to the next stage which is american regulation which is often much tougher. in europe medical devices
are approved by private companies called notified bodies. there are over 50 of them. we've discovered that the nanostim pacemaker was originally checked by a german notified body. they turned it down because of the lack of evidence. i would want to know if the german notified body thought there wasn't enough data to approve this device. you don't want to make a mistake because you can'tjust pull it out when it turns out that things went wrong or it wasn't a good or a safe and effective device. the european system allows companies to shop around. after being turned down by the germans, the nanostim was approved by the british standards institution. bsi won't tell us what evidence
they based their decision on due to confidentiality requirements. but we have got hold of the only clinical study. and it seems totally inadequate. 33 patients with a 90—day follow up. that's pretty tiny. they're supposed to last 10, 20 years. a 90—day follow up is not enough to learn much about the pacemaker. the whole system is so secretive. even the uk government's own regulator won't talk about individual devices. the mhra won't answer our questions about the pacemaker that killed three people. when we're talking about specific devices, you're aware that there's very limited information that we can share about that, we're bound by confidentiality when it comes to some of the actions that we've taken around individual devices. but the confidentiality surrounding implants means that even senior
members of the medical profession don't know what's going on. we are still not sure about the extent of harm that's being done by some devices and some types of implant. we know about a small number but the scale of the problem and the truth of the problem is still not fully apparent. # i've been searching all this time. it's notjust new products that can cause problems for patients. # whoa, whoa, whao! up to eight million women are thought to have had breast implants. i'm collete. even though we still don't really know how safe they are. and we've all had a breast enlargement. the most popular type of breast implants in the uk
are textured not smooth. a link has been discovered between textured implants and a rare form of cancer. it is a concern, absolutely, particularly now that we're seeing breast implant associated lymphoma developing in these ladies. so the risk is small, but it's a risk that we should know about and be informed of. i'm waiting for some biopsy results, which hopefully will be back next monday. it's quite a scary prospect really. janet trelawny had breast cancer over 20 years ago. her breasts were removed and replaced with textured implants. now she's been diagnosed with breast implant associated lymphoma. the old implant and the capsule were sent for biopsy, and then two weeks later that came
back that it was positive. and how did you feel when that diagnosis came back? devastated, i couldn't believe it. it's... it's frightening to think that something that i'd done because i've had a cancer previously, has then caused me to get cancer again. i was absolutely mortified, i wasjust so... i couldn't believe it. i'm frightened that this can happen and i'd no idea. the manufacturers say textured implants have been safely used for years and extensively studied. but we've discovered some didn't do basic tests to check they were safe. last week the french regulator announced it was warning against the use of textured implants while it reviews their safety. but women in britain are still having them put in. and what would you like the regulator to do? certainly more testing
to ensure that what they're putting into people's bodies is not harming them and also to maybe withdraw the products until that can be done. we know that there are ongoing concerns about the safety of breast implants, we're keeping a very close eye on that. we will take action where we see that there is a problem. but to spot problems you need to keep records. some evidence is collected here but it is voluntary. and that means we often don't know about problems caused by medical devices. every implant should be in a register because that's what defines patient safety. in the absence of that, we're in the dark. the first time we asked for a register for breast implants was 1993, and 25 years now, we're still uncertain
about the issues in breast implants. the problems with medical devices come down to weak regulation and secrecy. plans to strengthen the rules have been discussed in europe for a decade. but the industry says there are already proper checks in place to protect patients. it has successfully campaigned against substantial reform. for now. in europe. florence will receive her life saving medical device today. the main lobbying group for the european medical device companies was called eucomed. it used to be run byjohn wilkinson. eucomed essentially represents the interests of the medical technology industry across europe. in 2012 mr wilkinson changed jobs.
he went from being a cheerleader for the medical devices industry, to the person responsible for its regulation in the uk. do you think its appropriate that he should be head of medical devices at the mhra? john's brought extensive experience, he's brought great leadership. how impartial can you be if your paycheck up until that point has been solely industry and you have been instrumental in trying to stop the regulations even taking place, totally watering it down? i thinkjohn‘s record during his time in mhra speaks for itself. we think so too. we have obtained documents that set out the mhra's position on the regulation of medical devices. these documents show how the uk regulator was essentially supporting the industry's position. it's remarkable how little
difference there is. the government regulator doesn't want a central agency to oversee medical devices. neither does the industry. they both want to keep notified bodies. neither see any need to show that a device has a positive impact on health. and both are keen to get devices on the market quickly and to gather further evidence later. the industry and the british regulator got their way. the system is going to remain largely unchanged. it's a success for them and a failure for the european parliament. and for european patients, i have no doubt about it. that we could not do more for european patients and for the safety of european patients hurts and still hurt. sometimes it's the most vulnerable who can be hurt
by new medical devices. we've uncovered how a potentially harmful product became the preferred treatment for children on the nhs. but the story starts here in america. we're in california, a couple of hundred miles from san francisco. we're off to see anthony wainess. he was one of the first in america to have a totally new kind of device to help treat the curvature of his spine. this is anthony when he was nine years old. it's here. all the time i bend down, it's like a shark's fin at the back. anthony has suffered from severe
spinal problems for years. i hope i feel better with my spine straight. the conventional treatment is to insert metal rods. that can mean operations every six months, because the rods have to be extended as the child grows. a new medical device promised to make those surgeries a thing of the past. magec — magnetic expansion control — is a breakthrough technology capable of non—invasively adjusting implants by expanding or contracting the device inside the body from outside via remote control. in 2013, anthony had the titanium magec rods implanted into his back.
so what was it like for you when you had the rod? i was scared at first because... just because of the surgery, but also because i was gonna be the first person to do it. anthony was a severe case and was given special permission to have the operation. magec rods weren't approved for routine use in america at the time. but the inventors had already got them approved in europe without any live human study. the only studies were on pigs and dead bodies. there have been probably over 20,000 surgeries has been done and with fairly good results, but there are some complications, because they are very complicated patients. why did the company come to europe before it was put
through the fda in america? because it was not developed yet. so the rods that were not properly developed yet were used on british children. and some have been snapping inside them. we know that as rods extend, they're more vulnerable to the bending forces, which are the normal thing that cause rods to break, so there's quite a high implant failure rate because of that. mike gibson wanted to know more about the rods. but he didn't get the answers he needed from the company. so he asked scientists in newcastle to examime the rods he'd taken out of children. right. they were shocked by what they found inside. this is wear debris. wow. there's a lot of black come out there. would you want that going
into the spine of your child? no. the evidence is gruesome. these pictures show how titanium debris is leaking into the children's bodies. it's the black stuff. nobody knows what the long—term effects might be. the rods come in two sizes... the new research suggests the rods might not be effective either. i don't know if they're powerful enough. i don't know that the magnet generates sufficient energy or force to lengthen the spine. i think, from the work we're doing here initially, that they're not. the manufacturer, nuvasive, says magec rods avoid the pain and complications of conventional treatment and have been "shown to be effective". it says the rods have helped "rebuild patient and family lives". and the surgeon who helped design them says they are getting better. they're constantly working on it,
and they're improving, their new versions are, you know, coming all the time. but doctors don't know how the rods are being changed and tested. so how can they know the risks? these rods were breaking, releasing titanium debris into children's spines. does that sound like a safe and effective implant to you? it's important to remember that before any implant is put into anyone, there's a decision—making process, and there's a discussion between a clinician and a patient to understand the risks involved in that. so there's no role for the mhra there? of course there's a role, and there have to be basic... there have to be standards of safety and effectiveness before products can come to the market. of course we have to do that. a year after he had them fitted, one of anthony's magec rods snapped. do you remember what it was like when they broke? it was... it was really painful. were you disappointed, or how did you feel?
iwas... yeah, i was disappointed, especially... i had to get another surgery, ‘cos like the first time i got the surgery it was really painful, so i didn't really want to go through it again. but i had to eventually. the broken rod was replaced. a year later, it snapped again. the rods had to be permanently removed. it was a very low point for me. and it made me wonder, 0k, just how good was it to have these magec rods in to begin with? did we make a mistake? in the uk, magec rods aren't just approved — they are the recommended treatment for children on the nhs. the public body nice,
that made the decision, says it was taken after careful consideration of the clinical and economic evidence. nice recommends the magec rods for you on the nhs. what's your view of that? i think that was the most extraordinary thing. when nice turned around and said that it was... the position was that it should be your implant of choice unless there was a specific reason why you couldn't use it, and i was frankly... based on the evidence at that time, frankly staggered that nice said that. our system is so poorly regulated that devices can end up in patients even when the evidence shows they might be dangerous. we've been investigating a company in cambridge. ranier technology used to be based here.
ranier invented an implant that could replace a disc in your spine. the cadisc was approved by the british notified body, bsi. but four years later, it was taken off the market. in germany, 70 patients have already had the spinal implant removed. it was breaking up inside patients, leaving them in terrible pain. we're off to the stenum clinic. it's a orthopaedic clinicjust north of bremen in germany, and we're meeting a surgeon who's been taking out cadisc implants. it was never one piece, device we have to remove. so sometimes between 20 and 50 small pieces, a completely broken device.
it's hard to get all the bits of the device out. so patients can face multiple operations. how many times did you have to have surgery to have your disc removed? translation: i had three surgeries in total to have the disc removed, and now with the fourth one they inserted a different device. what did it look like? it had broken into i don't know how many pieces. so why was such a dangerous device approved for patients? we've obtained one of ranier‘s own scientific studies. they put a prototype of the spinal implant into five baboons. "0verall, six months is a relatively short time to follow an implant up." the research identified serious
problems with the device. "there appears to be worrying changes between the implant and the bone in all but one subject." ranier ignored the dangers and went ahead anyway. would you want to put that in a human? no. never. the european system keeps crucial information from doctors. dr ritter lang never saw the baboon study. if they present this datas to me, in this time, so i have tell them 0k, stop everything. you can also implant a piece of wood, you get the same reaction. but it's not a safe device. ranier‘s founder said the spinal implant was voluntarily withdrawn from the market.
the company "scrupulously followed the procedures and standards" required by all regulatory authorities. but the uk regulator, the mhra, signed off on the device being put —— we don't know if the spinal implant was used on british patients. but the uk regulator, the mhra, signed off on the device being put into human beings. why did the mhra allow that to go into humans? we can't talk about decisions that were taken, i think what i say is every clinical investigation that comes to us is assessed by specialists, is assessed by clinicians, and, if we need to, we'll seek an external clinical opinion on those. isn't that a failure of the system? i think we always, um... we don't like to hear of patients suffering, um... unfortunately, no effective clinical treatment is without risk, and the thing for patients to do is to liaise with their clinicians
and keep that going. ranier has now gone bust. but it's the system that really let patients down. does it shock you? yeah, so that's...very, very crazy. crucial decsions about transparency are still to be made in europe. should doctors and patients be able to see all the evidence about medical devices, or can companies continue to keep it to themselves? it doesn't look good for patients. we've been told that information about problems with devices, and how they are approved, will remain secret. in case it scares the public. well, it's not about scaring patients, is it? there are risks,
and that's the issue. you have to tell people. you can't withhold that. that's immoral, unethical and illegal in my mind. senior surgeons are are demanding immediate action. i think that government needs to address this urgently. the truth is the population is increasingly at risk, and that's not acceptable. we cannot go forwards exposing people to more risk. medical devices can transform our lives. but until we see the evidence they're safe, patients and doctors are making life—and—death decisions in the dark. welcome to bbc news, broadcasting to viewers in north america and around the globe. my name is mike embley. our top stories: president trump's former personal lawyer michael cohen pleads guilty to lying to congress over trump business interests in russia. he's a weak person, and what he's trying to do is get a reduced sentence.
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