As a way to highlight some of the more compelling testimony, here’s my selection of top quotes from the 98-minute documentary. How many people have been mis-diagnosed with a permanent disease process (like dementia) that actually have a reversible disease process. She credits her husband with holding the family together. She also has damage on the walls of her heart, and the lasting damage done to her kidneys is not known. After After Dr. Tower had the product replaced he began to study the effects of the products in his very own patients. She estimates she has only two hours each day that she can be active or be on her feet. Scott is still in a great deal of physical pain every day. When Dr. Tower called DePuy to see what could be done the company stated that they had never heard of a blood abnormality being an issue. Martin Makary – Professor of Surgery and Health Policy at John Hopkins School of Medicine, Most people probably believe when they get a medical device – be it a pacemaker or a joint – that those medical devices have undergone appropriate testing to demonstrate that they are safe and effective before they came on the market and doctors started using them – but for most moderate and high-risk devices that is not the case. For the 510(K) pathway all the manufacturer needs to demonstrate is that their device is ‘substantially equivalent’ – is the regulatory term – to another (predicate) device that’s already on the market. . Stephen Tower, an orthopedic doctor profiled in the film, had developed a tremor and was having a hard time thinking when he decided to scrawl all … That protection is clearly not working. Dr. Stephen Hoge told CBS News that research subjects who had received two doses of the vaccine “had seroconverted to develop antibodies in their blood that bound the virus.” Dr… ‪Orthopedic Surgeon: Anchorage Fracture and Orthopedic Clinic , Affiliate Professor UAA/ WWAMI School‬ - ‪Cited by 1,464‬ - ‪arthroprosthetic cobaltism‬ - ‪Metal-on-Metal hip replacements‬ - ‪cobalt poisoning‬ - ‪cobalt or chromium induced lymphomas or leukemias‬ David Kessler – FDA Commissioner (1990 – 1997). Carbon monoxide poisoning typically occurs from breathing in carbon monoxide (CO) at excessive levels. As always, the patient stories are truly heartbreaking (and often clinically gruesome), but what makes this documentary different is the sheer volume of clinical and legal testimony aimed so directly and forcefully at the FDA – the one organization purpose-built to protect patients from a wide range of clinical risks – including those from medical device manufacturers. It takes a physical toll, she said, but it’s one of the few things she has that makes her feel normal. Doctors say Linda Radach's heart failure is caused by metal poisoning from her implanted hip. There is a system for reporting complications, but there’s tremendous underreporting because it’s a voluntary system. The first time she tried it, she visited a rink in Austin, put on a lot of extra pads, and thinking “what the heck,” slowly pushed her way across the ice. Scott also spends as much time as she can helping others suffering because of faulty medical implants. One compelling example is that of Dr. Stephen Tower, a surgeon from Alaska. June 3, 2016 After discovering that he had cobalt poisoning due to corrosion of his hip implant Dr Steve Tower began to investigate how extensive this problem is … * This post was updated on 8/3 and then corrected on 8/4 to include a link to Bayer's response to the film in their press release dated 7/27. Eight weeks after the procedure, she dislocated one of her hips, an extremely painful setback. Part of her time is devoted to her job as a spokesperson for the flooring company 50 Floor. “It’s about one hour a day on my feet, five days a week,” Scott said. Stephen Tower, MD, University of Alaska, Alaska, USA . “But right now I get about two hours a day on my feet and that’s it. View Dr Tower's Presentation on Metal Poisoning and Brain Toxicity in Patients With Hip Implants View Dr. Bridge's Presentation on Brain Toxicity From Cobalt in Artificial Hip Implants As Seen on PET Scan Dr. Tower is an orthopedic surgeon who knows these replacement parts inside and out – after all, his profession involves inserting them into patients! “I asked him years later why he stayed with me, because I was a lunatic. ... giving him cobalt poisoning. At one point Skip said, ‘You don’t want us to remember you this way,’ and it really hit home. In the season 16 finale, Richard (James Pickens Jr) was revealed to have cobalt poisoning from a leaky hip replacement. “Very few people understand what replacements they … He now advocates for testing the cobalt levels of … Scott said many people find her because of the KVUE article and through her YouTube page, where she has posted videos about her struggles with the metal-on-metal hips. Opinions expressed by Forbes Contributors are their own. It was terrifying.”. A large number of the hips implanted in the United States over the past 20 years have utilized chrome-cobalt parts. Cobalt poisoning can also occur from the wear and tear of some cobalt/chromium metal-on-metal hip implants. All Rights Reserved, This is a BETA experience. Stephen Tower, an orthopedic surgeon, specifically asked his surgeon for a metal-on-metal device called the ASR XL that was manufactured by Johnson & Johnson when he needed a hip replacement. And the reason was something he never suspected: cobalt poisoning. People think Pharma’s got power. When metal implant components rub together, they can release cobalt and chromium ions above those natural levels. David Kessler – FDA Commissioner (1990 – 1997). We couldn’t do that. Dr. Stephen S. Tower is an orthopedist in Anchorage, Alaska and is affiliated with multiple hospitals in the area. Other things she could not fake. . “I was horrifically miserable, but then I had these blemishes breaking out on my face that would just crack open and bleed, and I was starting to get embarrassed about my appearance. I write at the intersection of healthcare technology and policy. He has been in practice for more than 20 years. 10 Tuesday Dec 2019. I was just really embarrassed and ashamed that I didn’t just pop back from surgery.”. I need to have something that I can still do that I enjoy. Scott said she knew not long after returning to work in early 2012 that something wasn’t right. Scott knows just how fortunate she is because she has gotten to know many people who were in her same situation and didn’t get the same support. To make matters worse, Scott learned that Johnson & Johnson DePuy, the company that manufactured her Pinnacle hip, knew the problems with the hardware and kept selling them anyway. Meanwhile, Scott said her behavior at home — the crying, the rage — was disruptive to her family. EY & Citi On The Importance Of Resilience And Innovation, Impact 50: Investors Seeking Profit — And Pushing For Change, The Grimmest Days Of The Covid-19 Pandemic Coincide With The Most Severe Forms Of Rationing, How To Decipher The New Pfizer Study On Vaccines And Variants, Why The U.S. Cobalt poisoning by hip replacement: Arthroprosthetic-Cobaltism . Presently, Dr. Tower and DBEC are studying why corrosion of chrome-cobalt alloy hip implants occurs and how often this leads to hip tissue damage or to cobalt poisoning/cobaltism. Posted by earlstevens58 in Chrome Poisoning, Cobalt chrome, Cobalt Poisoning, Cobaltism, FDA, Hip, Hip Replacement, Hip Revisions, hip surgery, Hip Wear Characteristics, Metal ions, Metal on metal hip, metal on metal hips, Metallosis, metallosis ≈ 2 … The classically described "cherry red skin" rarely occurs. Dr. Stephen Tower, a Health Watch USA Board Member, has discussed this problem in a recent commentary along with several recent reports that are now calling attention to the long-term dangers of cobalt containing implants and their all too common toxicity. Absolute molybdenum concentrations in the diet >10 mg/kg will cause poisoning independent of copper consumption. My head started to clear.”. Their doctors aren’t even checking them for this, and their marriages are being destroyed by it.”, During this time, Scott had been seeing a doctor in Austin who, like her doctor in Raleigh, told her there was nothing wrong with her hips and that he could not help her. He said, ‘I knew it wasn’t you. I still have tried to make good memories with them, but it’s always there. Update: Bayer responded to the documentary (including specific claims of failure rates and their decision to voluntarily withdraw Essure from the market at this end of this year) in a press release here: Bayer Fact Checks Netflix's The Bleeding Edge *. “Google Videos “Cobalt Hip Brain Toxicity” Please “Re-Tweet” to anyone with a replaced hip.” In March 2015 he started a screening program to measure cobalt levels in the blood of patients who received an artificial hip with any chrome-cobalt component. (Scott was part of a multi-district litigation case but she hasn’t received an offer from Johnson & Johnson DePuy, and she doesn’t think she will.). Dr. Tower … After six months of going five days a week, Scott said she would limp to the rink, skate through the pain, then feel good for about an hour after. Misinformation About HPV Vaccine Goes ‘Viral’ In Thousands Of Facebook Posts, Putting The Consumer At The Center Of Healthcare, Walgreens CEO Pessina: We’ll Spend Distributor Sale Proceeds On ‘Pharmacy Of The Future’, The Risks Of Delaying Or Diluting Covid-19 Vaccines, Walgreens To Sell European Distribution Business To AmerisourceBergen For $6.5 Billion, Bayer Fact Checks Netflix's The Bleeding Edge. (The company discontinued metal-on-metal hips in 2013 and agreed to a $120 million settlement last month involving claims in 46 states.). Are these people (with metal joints) being relegated to the dust bin because they have what somebody misperceives as dementia. The male patient presented with profound peripheral neuropathy, a metal laden pericardial effusion, and immune thyroiditis in 1997. Notable elevations of cobalt and chromium were detected in the patient’s blood and urine. Cobalt, in excess, has the potential to block oxidative metabolism at the mitochondrial level. So, the vast majority of devices today – regrettably – are regulated under this [510(K)] framework. Stephan Papageorgiou, Allgemeinmediziner in Hamburg-Barmbek, Fuhlsbüttler Straße 151. Scott’s family moved to Austin later that year. Presently, Dr. Tower and DBEC are studying why corrosion of chrome-cobalt alloy hip implants occurs and how often this leads to hip tissue damage or to cobalt poisoning/cobaltism. “So I’m lucky.”. While patient horror stories are always tragic – and there are many horrific ones in The Bleeding Edge – they rarely include practicing doctors as victims. Journal of Patient Safety: October 10, 2018 - Publish ... Dr. Stephen Tower, on the epidemiology and mechanisms of failure of total hip arthroplasty and associated heavy metal poisoning. My first book – Casino Healthcare – released in 2016. So, it came as a surprise to him when he began experiencing symptoms of illness due to his hip replacement surgery. Skating has been more difficult since the revision surgery, because the impingement causes pain. Since making that discovery, Scott has been on a mission to repair her body, her life and her family, and to help others searching for answers. . I've covered a number of healthcare documentaries (including Escape Fire and The Business of Recover), but this one's a very powerful indictment of the exact agency designed to protect patients from a large and powerful industry segment. Die Werke sind auch als der Dunkle-Turm-Zyklus bekannt. Some of the most forceful testimony came from Dr. Stephen Tower, an orthopedic surgeon who suffered severe cobalt poisoning from his own hip implant, and has since dedicated himself to researching metal poisoning by hip implants. DURHAM, N.C. (AP) — When Frances Scott left the Triangle’s WTVD in early 2012, she was at the top of her professional game, one of the ABC station’s most recognizable and beloved anchors. …..if there’s a disagreement between the marketing and the medicine, “the marketing is always going to win out,” says a lawyer for injured patients. While patient horror stories are always tragic – and there are many horrific ones in The Bleeding Edge – they rarely include practicing doctors as victims. Tower worked backwards to figure … The primary metal alloy for these joint replacements is cobalt, and according to the documentary, there are now more than 10 million people worldwide who have hips, knees or shoulders made with cobalt parts. Systemic cobalt poisoning from excessive wear of a hip implant was first reported in 2001. “How many people are out there who think grandma is acting weird because she has dementia?”. “It’s just staggering. She was also getting tested for chromium and cobalt poisoning during this time, and results showed cobalt levels in her urine much higher than normal. One of the speakers this year is Dr. Stephen Tower, a surgeon from Anchorage, Alaska. Soon after arriving at a certain diagnosis, Dr. Tower will often turn to surgery when all other treatment solutions have already been eliminated or exhausted. This is a problem on any knee, shoulder or hip with a chrome cobalt implant," said Dr. Tower. Settled in Austin, she started doing more research and learned about trials in Dallas involving Johnson & Johnson DePuy. Since Dr. Tower focused on complex hip replacement surgeries, he was familiar with the procedure and the options available. Robert Bridges – Diagnostic Radiologist, It used to be that about 70% of biomedical research was funded by the government, [but] in the last 20-25 years, that’s changed. Twitter handle is: @danmunro, © 2021 Forbes Media LLC. (Contributed by Stephen S. Tower, MD, Anchorage Fracture and Orthopedic Clinic.) A recent case report by Dr. Stephen S. Tower, published in the Journal of Bone and Joint Surgery, examined two cases of arthroprosthetic cobaltism attributed to metal-on-metal implants. Around this time she also watched a 2017 Netflix documentary about the medical device industry called “The Bleeding Edge,” which featured Dr. Stephen Tower, an orthopedic surgeon with a metal-on-metal hip having the same neurological symptoms as Scott, including manic episodes. Piper then discovered the work of Dr. Stephen Tower, an orthopedic surgeon from Alaska whose own metal-on-metal hip implant problems spurred his scientific research into cobalt poisoning. She still has ringing in her ears and considerable pain from an impingement caused by a piece of the new hip rubbing against and tearing muscles and tendons. So many people are not only physically disabled by this and losing hearing and having vision problems, but the worst part is I know this is destroying families, because it almost destroyed mine. Cobaltemia and Cobaltism are common in Alaskans with failed Metal-metal Hips by Dr Stephen Tower Introduction Systemic cobalt poisoning from excessive wear of a hip implant was first reported in 2001. No, no, no – the device industry has much more power than pharma. “It was a horrible time and it’s sad for me to talk about now, because I know so many people — their spouses do leave. Deborah Cohen – Associate Editor, British Medical Journal, That [510(K)] provision which was meant as an exception – in essence a little loophole – that exception became the rule. I’m really lucky.”, Information from: The News & Observer, http://www.newsobserver.com, Connect with the definitive source for global and local news. Dr. Stephen Tower, Anchorage AK, discusses the risks associated with metal-on-metal hip implants during a Health Watch USA meeting on Feb 19, 2014. Following extensive research into his own case and others like it, Dr. Stephen Tower’s coined the term Arthroplasty Cobalt Encephalopathy, or ACE , … But the revision surgery wasn’t a total fix. In The Bleeding Edge, Dr. Tower wonders if some elderly patients – the ones most likely to need a hip transplant – might have been wrongfully diagnosed with a form of dementia, when in fact they were showing signs of a reversible condition, instead. This type of implant is an artificial hip socket that is created by fitting a metal ball into a metal cup. “That (job) has helped me tremendously. And FDA does a credible job with the vast majority of products. • Dr. Tower’s decade of experience attempting to raise awareness of the risk of cobalt poisoning from chrome-cobalt “Stephen Tower, a physician, received a chrome-cobalt replacement hip, which he suspects poisoned him and led to a mental breakdown. Her husband, a CPA, was from Texas and went to school at Baylor University in Waco. (Scott later looked up her doctor on Propublica’s Dollars for Docs website and learned he had taken nearly half a million dollars from Johnson & Johnson DePuy as a consultant.). . “The evidence was jaw-dropping,” Scott said. Needs To Step Up Covid-19 Genome Sequencing. This type of implant is an artificial hip socket that is created by fitting a metal ball into a metal cup. “There were not many people in the ice rink in the middle of the day, and I didn’t have to be embarrassed that I limped or couldn’t skate.”. 1 out of 4 are immune to cobalt, 2 out of 4 react fairly reasonably to cobalt implementation, and the other 1 out of 4 is extremely sensitive, causing early on-set diseases. I said, ‘Don’t leave me, don’t divorce me, but you need to take the kids and go to a different place where they don’t have to be around this.’ And he didn’t. Dr. Stephen Tower, a Health Watch USA Board Member, has discussed this problem in a recent commentary (journals.lww.com/journalpatientsafety/Citation/publishahead/Hip_Metallosis_and_Corrosion_A_Million_Harmed_Due.99566.aspx) along with several recent reports that are now calling attention to the long-term dangers of cobalt containing implants and their all too … An Analysis of the FDA MAUDE Database and the Search for Cobalt Toxicity in Class 3 Johnson & Johnson/DePuy Metal-on-Metal Hip Implants. That’s the thing I still really have grief about. Diese Website wurde für deutsche Benutzer erstellt. She was also physically and mentally broken. Dr. Tower’s Chrome Cobalt Hip Study. Dr. Stephen Tower is an orthopedic surgeon specializing in complex hip replacements. We are seeing this with many popular hip designs that are still commonly implanted.” OTW spoke to Dr. Tower about his personal experience with cobalt poisoning and research in the area. I had known you for 12, 13 years before this, and none of what you were doing matched who you were before the surgery, so I just knew in my gut it wasn’t you.’, “Also, he stayed because that’s the kind of person he is,” Scott said. KVUE, the ABC affiliate in Austin, reported on Scott and the FDA’s shortcomings in testing medical devices in February of this year. This is a problem on any knee, shoulder or hip with a chrome cobalt implant," said Dr. Tower. It is a far more common side effect than you might think, and one that should have been anticipated by DePuy long before they started selling this defective medical device to patients. Scott attended two of the trials, making the three-hour drive each way so she could listen to everything they said in the hearings. Scott Whitaker – President & CEO of Advanced Medical Technology Association (medical device lobbying organization). Depending on severity of findings, replacement of the artificial hip with one not made of cobalt or the use of chelation may be necessary. www.tjrclinic.com. “My hands would shake sometimes in the morning meeting and I’d think, ‘Wow, I’ve had too much caffeine.’ I got lost on I-40 on one of my last days coming back from a doctor’s appointment, headed from Durham to Raleigh. As surgeon has implanted about 1000 “AT RISK” hips. Now, about 70% of biomedical research is funded by industry. Astonishingly, Dr. Tower discovered that over half of his patients with a chrome … Stephen Tower Authority on cobalt poisoning by hip replacement (cobaltism), Affiliated Professor UAA/ WWAMI, surgeon Anchorage, Alaska 500+ connections Tower Joint Replacement Clinic. We spent all our money on surgeons.”. First appearing in Forbes as a Contributor in 2011, I've written for a wide range of global brands and print publications. “I didn’t know what, but I couldn’t control it and it made me sad. He discovered that 57 were cobalt positive, meaning the cobalt urine test revealed 1 part per billion (ppb) or higher. Case Report Cobalt poisoning can also occur from the wear and tear of some cobalt/chromium metal-on-metal hip implants. Of the 57 patients with a cobalt positive test, 28 had symptoms consistent with Arthroplasty Cobalt Encephalopathy. Dr. Tower is an orthopedic surgeon in Alaska, trained to treat and diagnose all forms of injury to your musculoskeletal system, including the joints, muscles, bones, tendons, and ligaments. The metallosis that developed wreaked havoc on Dr. Tower’s tendons, ligaments, and muscles. If a physician observes an adverse event, they do not have to report it. Stephen S. Tower, M.D. “But I can still skate two days a week — because I need to. Jim Spencer – Journalist, Minneapolis Star Tribune, Sure, we’ll pay attention to Washington, that’s my job, that’s what I do – but we have more power in this room than most governments around the world. He got a job doing accounting for a small pet products company based in Austin. We are seeing this with many popular hip designs – orthopedic surgeon Stephen Tower. Schooled by personal experience, and later by research, he finds cobaltism to be common in his patients with hip, shoulder, or knee replacements. Before leaving Raleigh, Scott had read an article in The New York Times about the DePuy Pinnacle hip being pulled from the market. “The kidney pain, the confusion. What Dr. Tower experienced – what so many patients have experienced – is the effects of cobalt poisoning. I’m hanging on to the skating with my last bit of strength.”. Monday, June 6, 2016, at 2:00 p.m. After discovering that he had cobalt poisoning due to corrosion of his hip implant Dr Steve Tower began to investigate … The male patient presented with profound peripheral neuropathy, a metal laden pericardial effusion, and immune thyroiditis in 1997. It’s something she started while still in Raleigh and was able to continue after moving. It’s like a 6th member of our family, this nightmare. The other danger for cobalt poisoning is that it could mimic other conditions. Everyone — her, her family, her doctors, her employers — expected her to be back at work and back to normal in a matter of months. Filmed in 2002 during the actual hearing process, members of the panel are seen laughing about the personal consequences if the device ever failed in the future. Depending on severity of findings, replacement of the artificial hip with one not made of cobalt or the use of chelation may be necessary. It’s estimated that only 3-4% of adverse events are reported to the FDA. Who gets lost on I-40? Dr. Steve Tower specializes in hip, knee and shoulder surgery as well as general orthopedics and trauma care. No economic COI. It’s kind of a parallel to the drug industry and it isn’t nearly as well understood. “It simulated that feeling that I always loved of running with the wind going past your face,” she said. He had cobalt poisoning. Doctors say Linda Radach's heart failure is caused by metal poisoning from her implanted hip. Massive adoption of a new technology with little evaluation of the outcomes. Dr. Tower stressed that the threat is not limited to metal-on-metal implants. Some of the most forceful testimony came from Dr. Stephen Tower, an orthopedic surgeon who suffered severe cobalt poisoning from his own hip implant, and has since dedicated himself to researching metal poisoning by hip implants. Her twins were 7 at the time all of this started, and her youngest was 5. He now advocates for testing the cobalt levels of his patients if they complain of having Parkinson’s or dementia-like symptoms. There ’ s estimated that only 3-4 % of adverse cases, and I something! 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