After watching the documentary film “The Bleeding Edge” on Netflix I thought I should weigh in as a patient who has had both of my hips resurfaced, meaning my hip joints are metal on metal ball and sockets.
The film is a very well done documentary that examines the $400bn medical device industry that reviews five products that have exhibited significant failures including the broad review of cobalt based hip implants. This is an important documentary that does expose the weakness of our regulation of the medical implant industry and sounds a needed alarm to those patients who may now be at risk.
I am focusing on hip resurfacing which was lumped into the broad exposure of any metal joints made from Cobalt. The greatest concern comes from these devices that actually operate with a metal on metal joint, and hips are probably the most common. My hips are made of a Cobalt-chrome alloy that is used because it creates one of the hardest and strongest metals known to man. These features are critical for a successful and enduring joint replacement. The premise for using a metal on metal hip as in my case is that the body naturally encapsulates and provides lubrication for the joint movement. The Co-Cr alloys show high resistance to corrosion due to the spontaneous formation of a protective passive film composed of mostly Cr2O3. The minor amounts of cobalt and other metal oxides on the surface appear to be contained by the body’s encapsulation. The documentary does not spell this out in sufficient detail, instead it broadly classifies any device made from cobalt as dangerous.
My History: My family has shown a propensity toward the development of an arthritis that creates some bone deposits in our hips. For me this has been accelerated by a life of sports activity, most notably basketball, that allowed this arthritic condition to wear away the natural lining of my hip joint. Once I understood this back in 2006 when I was 52 years old and in constant pain I had to figure out a solution. I had heard that hip replacements were good for 15-20 years which did not seem to match well with my age. I remember hearing about hip resurfacing in a 60 Minutes type segment on Americans traveling to India for this surgery. So I started investigating this alternative procedure. The allure for me was the fact that you could remain active and if needed down the road I could still get a hip replacement. Fortunate for me there was an orthopedic surgeon in Salem, Oregon, who was allowed to perform this surgery probably due to the FDA’s 510(k) pathway for approving medical devices as mentioned in the documentary. My first hip was his 439th hip resurfacing. I do believe that my second hip done in 2010 was from the same design and stock of the Cobalt-chrome implant.
I guess the point of my post is to let it be known that hip resurfacing can be very positive. So why have I not experienced any cobalt poisoning related medical issues? Obviously the surgery can be positive, however, it is true that many have experienced serious problems. Depuy, owned by Johnson & Johnson, was referenced in the documentary, however, there has been recall activity on cobalt based joints from Stryker and Smith Nephew. My theory for my success is based on the fact that the hips that were used for me were created in the early pre FDA approval period. I have asked who made my hips and I never got an real answer. They appear to be similar to the Smith Nephew BHR and the Wright Conserve systems. Maybe those early test hip parts were done with more attention given to the metallurgy involved. Possibly my success has to due with my lifestyle. I have learned that I cannot participate in physical activity that is based on radical lateral movement such as basketball or handball. What I can do is walk or backpack which I have done to the tune of about 2000 miles since my second hip surgery. So overall I am extremely thankful for this medical hip resurfacing technology.
I do hope that the FDA is able to improve the overall approval process for medical device technologies and it is good that documentaries are made to help bring attention to these needs. But we must also caution against blanket assumptions made to help sensationalize a documentary, such as all devices made with cobalt are bad for you.