More than ten years after researchers began to warn that metal-on-metal hip implants could shed tiny pieces of metallic debris into the bloodstream, the devices have become the subject of one of the country’s largest medical device failures, fueling a public health problem that continues to plague both doctors and patients.
An interesting article published in the New York Times tells the story of a female patient who learned that the artificial hip she received in 2007 was being recalled by its manufacturer, DePuy (a division of Johnson & Johnson), due to a high a failure rate. Her story not only communicates the importance of early diagnosis in patients with these faulty all-metal hip implants, but it also serves as a means by which to educate those same patients regarding the procedural options available to help reach the right diagnosis.
Cyndi Lafuente visited her surgeon immediately following DePuy’s recall announcement in September of 2010. When the results of her blood tests came back normal, her doctor suggested that she “wait and see” what develops. However, Cyndi continued to ask questions and advocate for her own wellbeing. She was experiencing intermittent discomfort in her groin and also endured unexplained joint pain in the replacement hip after hiking on uneven terrain. Additionally, the emotional pain of not knowing what was going on in her own body was quite taxing. Given her symptoms, Cyndi’s doctor ordered an MRI and a CT scan with differential in order to identify the problem. The diagnostics were intended to rule out existing damage from a failed ASR and referral back pain. Given the fact the tests came back negative, Cyndi’s surgeon still maintained a “wait and see” position regarding her diagnosis.
Unfortunately, undiagnosed metallosis can cause permanent damage, beginning with the bone and muscle tissue that surrounds the joint. Knowing this, Cyndi was extremely concerned about what could happen to her body during this waiting period. To that end, she continued to investigate the issue, eventually finding her way to the original surgeon who identified the dangers of ASR and excessive metal. The surgeon, Dr. David Langton, suggested that Cyndi get her hip aspirated, as the metal first appears in the synovial fluid, before making its way into the bloodstream. Dr. Langton further explained to Cyndi that UK docs are more accustomed to use aspiration as a primary diagnostic tool because MRIs and CT scans are so expensive. Conversely, doctors in the U.S. routinely order CTs and MRIs in order to avoid more invasive tests. Armed with this new and helpful knowledge, Cyndi returned to her own surgeon. After some discussion, she and her doctor ultimately decided to move forward with the hip aspiration procedure.
Results from testing the serum taken from Cyndi’s hip revealed that her metal count was ten times higher than the normal level. As such, Cyndi underwent revision surgery in June. Thankfully, no permanent bone or muscle tissue damage had occurred as a result of the original device. However, several months after her successful revision surgery, Cyndi is still on the long and difficult road to recovery.
Cyndi’s story is a compelling example of the pain, uncertainty and frustrations that many patients have experienced as a result of an all-metal hip implant. By sharing her experience, Cyndi has provided much needed insight into the importance of aspiration procedures with regard to early diagnosis of metallosis.
In order to properly diagnose the problems associated with all-metal hips, the knowledge of a specialist is often required. Unfortunately for most patients, by the time they realize they need a specialist, lasting damage may have already taken place. New research out of England has revealed that all-metal hips are failing at three times the rate of hips made of metal-and-plastic parts, which can last up to 15 years or more. In the first six months of 2011 alone, the FDA received more than 5,000 reports of problems associated with all-metal hip implants. To that end, the Food and Drug Administration has required the makers of all-metal hips to develop studies in order to determine how frequently their devices fail, as well as to better assess the future implications of device failure for patients.