Rx for Change: Excuse Me, Is That a Metal-on-Metal Device You’re Wearing?
Taken from the January/February 2012 issue of The Women's Health Activist Newsletter.
Unsuccessful hip replacement, however, can result in more pain and an inability to walk at all. And, devices with a metal ball and socket (metal-on-metal, or MoM) can cause other problems, some of which are extremely dangerous. Astonishingly, the Food and Drug Administration (FDA) allows some types of joint replacement devices to be used without any clinical studies on safety or efficacy.
The earliest recorded hip replacement procedure, performed in Germany in 1891, replaced the femoral head with carved ivory. Thankfully, many elephants and walruses have been spared as surgeons and engineers pioneered prostheses made of metal, plastics, and ceramic components!
Today, there are hundreds of designs of artificial joints. In some countries — including Britain, Sweden, Norway, Denmark, South Africa, and Australia — detailed data on joint replacement patients is entered into national registries. Registries help curtail the widespread use of dangerous products by quickly identifying devices with high failure rates and other problems, and allowing physicians and patients to be alerted when problems are found.
Each year, over 600,000 Americans have hip and knee replacement surgeries; hospital costs alone from the procedures will exceed $65 billion in 2015. Despite leading the world in joint replacement procedure frequency, however, the U.S. has no comprehensive joint replacement registry, nor is one planned by any government agency, the American Academy of Orthopedic Surgeons, or the highly profitable joint replacement manufacturing industry. As a result, Americans’ health is jeopardized by unsafe and ineffective devices.
A recent case illustrates the devastating effect of unfettered industry combined with lax Federal regulation. DePuy Orthopaedics, a division of Johnson & Johnson, is the world’s largest hip replacement device manufacturer. DePuy promoted its Articular Surface Replacement (ASR) MoM device as a “breakthrough design” that would last 15 years (like comparable devices) or longer. In 2005, the FDA cleared DePuy to market the ASR in the U.S. without conducting any human safety trials. Like many medical devices, the ASR was approved as “substantially equivalent.” This means that, although it had a new design and untested combination of materials, the FDA considered the ASR to be enough like existing devices to be put directly into humans without any specific safety research or requirement for DePuy to monitor its actual performance or safety.
By 2008, the FDA had received about 400 complaints from patients. Orthopedic surgeons also began seeing unusual symptoms and early failures with the ASR. When they alerted DePuy, the surgeons were told the ASR was fine, and faulty surgical techniques were at fault. At the same time, savvy nations with joint registries began to note an epidemic of ASR failures.
Other problems soon became evident. When surgeons began to replace the ASRs, they found tiny metal fragments had sloughed off the device and inflamed tissues; some patients had permanent damage to tissues adjoining the ASR. Another horrifying complication was heavy metal poisoning caused by cobalt and chromium released by the ASR and absorbed into the patient’s blood. Cobalt poisoning can cause neurological symptoms (like tremors, cognitive decline, and hearing loss), cardiac arrhythmias (abnormal heart rhythms), and hormonal problems. Some patients without any hip-related symptoms developed severe illnesses from toxic cobalt levels.
Despite accumulating evidence on how shoddy the device was, DePuy promoted the ASR and eventually sold about 93,000 worldwide (about 30,000 in the U.S.). In early 2010, DePuy announced it would phase out the ASR because of declining sales. In August, 2010, DePuy voluntarily recalled the ASR and said it would pay for surgery to replace it, if needed. Replacing dangerous and ineffective ASRs will help some patients, but others already have such extensive and permanent damage that surgery won’t help. Others may have no hip problems, but may develop cobalt poisoning, which, if unrecognized, can cause permanent harm.
Have the ASR debacle and problems with other joint replacement devices spurred the U.S. to invest in a national joint registry? Not really. There’s been a tiny start, but a lot more huffing and puffing about how to maintain privacy of patient information, if the registry could report problems to the FDA, and concerns about cost. Give us a break! This is a multibillion-dollar industry with at least 50% of the bill footed by U.S. taxpayers through Medicare and Medicaid. What about patients’ lives and well-being?
Actually, one U.S. health insurer can show us the way. In 2001, Kaiser Permanente started its own joint replacement registry, which has improved quality and saved costs. Kaiser’s surgeons use registry data to guide their techniques and select which joint implant to use. When another hip implant was recalled (before the ASR), Kaiser was able to notify its patients promptly.
If you, or anyone you know, had hip replacement from 2005-10, learn the device’s make and model. If it is an ASR or other MoM device, take this article to your primary care doctor AND your orthopedic surgeon, and get both an in-depth evaluation of the device and blood tests to assess cobalt and chromium levels. We can all contact our Congressional representatives to demand the U.S. catch up with other nations and Kaiser by creating a state-of-the-art, national joint replacement registry.
Charlea T. Massion, MD, is a practicing physician in Santa Cruz County specializing in hospice and palliative care. Charlea brought her passion for improving women’s health along with 40+ years of health care experience to the NWHN as a member of the board for 8 years. She also co-founded the American College of Women’s Health Physicians.
Adriane Fugh-Berman, MD, is a former NWHN Board Chair whose research presents a critical analysis of the marketing of prescription drugs. Adriane educates prescribers on pharmaceutical marketing practices as Director of the PharmedOUT program, and created the Health in the Public Interest program at Georgetown University School of Medicine where she trains a new generation of consumer advocates.
Read more from Charlea T. Massion and Adriane Fugh-Berman.
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Australia Orthopedic Association (AOA), AOA National Joint Replacement Registry: Supplementary Reports, 2011: Investigations of Prostheses with Higher than Anticipated Rates of Revision, University of Adelaide SA, October 2011. Available at http://www.dmac.adelaide.edu.au/aoanjrr/publications.jsp
Food and Drug Administration (FDA), “Information for Patients Who Have Metal-on-Metal Hip Implants”, Silver Spring, MD: FDA, Updated 2/10/11. Available athttp://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/ucm241766.htm#q4
Meier B, “Remedy Is Elusive as Metallic Hips Fail at a Fast Rate”, New York Times, September 30, 2011, page A1. Available at: http://www.nytimes.com/2011/10/01/health/01hip.html?pagewanted=all
Meier B, “Metal Hips Failing Fast”, New York Times, September 15, 2011, page B1.Available at: http://www.nytimes.com/2011/09/16/health/16hip.html
Meier B, “Implant Loophole”, New York Times, December 16, 2010, page B1. Available at: http://www.nytimes.com/2010/12/17/business/17hip.html?scp=1&sq=hip%20j&J=&st=cse&pagewanted=1
Paxton E, “The Kaiser Permanente National Total Joint Replacement Registry”, The Permanente Journal2008; 12(3): 12-16.
U.K. Medicines and Healthcare Products Registration Agency (MHRA), “Medical Device Alert: All metal-on-metal (MoM) hip replacements (MDA/2010/033)”, London: MHRA, April 22, 2010. Available online at http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON079157