My Journey into Patient Safety
THE LONG & SHORT OF IT
Growing up in rural Northwest Iowa, my sense of belonging and rootedness has always been strong. Based in a family heritage that ran back to the Dutch immigrants who established and founded the area, hard work and honesty were values held in high esteem. A clear sense of justice, right and wrong, provided the foundation for all of life’s interactions. Although my father was not Dutch, he was made of the same stuff – meet an obstacle, find a solution, overcome the obstacle. Whenever any of us kids would come to him discouraged, hurt, or frustrated with life’s circumstances, he would listen and then look at us and say, “How do you spell your last name?”
To which we would reply, “L-E-S-L-I-E.” Then Dad would end the conversation with an edict,
“That’s right! Now get up and go do something about it.”
Looking back, I remember hating those pull-yourself-up-by-the-bootstrap moments, but I can see how Dad’s attitude has influenced me. Life has not been, and rarely ever is fair. How we respond determines whether those hardships will make or break us.
Between 2006 and 2012, I had 5 hip replacement surgeries, with the sixth and most recent being done in April 2017. The cause of these repeated surgeries was the use of metal on metal devices which were never tested. Whether the surgeon knew or was duped by the device company remains unknown. A long, trying, series of cascading events has resulted in a life of chronic pain, forced retirement, and never-ending worries about my health. Participating in the routines of life is a constant challenge, but to me, doing nothing is not an acceptable option. So I continue to push myself with chores in our home and yard. The more active I am, the better my soul feels, but there is always a price to pay. Increased levels of activity bring increasing levels of pain. Muscles are atrophied, resulting in poor endurance for walking; requiring me to use crutches. My overall health is compromised by elevated blood serum levels of chromium and cobalt – the materials used to make all or part of my various hip prostheses. While researchers have been slow to study the effects of these levels, the FDA and the American Academy of Orthopedic Surgeons consider low elevated levels normal for bilateral hip joints. Yet, according to OSHA and the MSDS documents for cobalt and chromium, my levels are toxic! Every doctor or dental appointment I have requires me to educate the provider about the risks and health issues associated with these untested devices.
I believed my doctor when he said the hip implant had been approved by the FDA and would last twenty years, perhaps my lifetime. I wish I had known that surgeons get their information about the prostheses they use from a sales representative working for the device company which manufacturers those devices. I wish I had known that my surgeon was being paid by the device company to consult, research, use, and teach other physicians about the implant he chose. I maybe would have challenged some of his statements if I had known that less than five percent of medical devices are ever tested for safety and effectiveness through scientific, clinical trials in humans. Red flags would have popped up if I had known that the FDA stamp of approval did not guarantee the safety of my hip implant or any effective outcomes. I wish I had understood that while device companies are required to jump through regulatory hoops, those regulations do nothing to protect patients. I wish I had thought to ask simple questions about the design of the implant, why it was an appropriate choice for me, and what materials were used to make the device. I trusted that the materials which made up the component parts of the hip implant would have been wisely selected for bio-compatibility. How is it that a plumber knows not to put dissimilar metals together in a wet environment, but the FDA and device manufacturers sold prostheses with titanium and cobalt-chromium alloys used in the same device? I wish I had known that the cobalt-chromium was going to lead to heavy metal poisoning; a threat to my heart, vision, kidneys, and cognitive capabilities.
Officials in the USA cannot track specific devices, and we do not have a truly effective and open device registry. The FDA is incapable of handling adverse event reports. The use of Unique Device Identifier (UDI) technology only recently was adopted, and its use is inconsistent across the nation. The FDA approval pathways by which medical devices reach market do not set priority on safety and efficacy. Patients, like me are having their lives turned inside out and upside down, relationships fail under the strain, and as health fails, productivity goes down. Although many believe joint replacement surgery to be a huge success story, there are nearly a million patients who have been harmed by hip implant failures. Unfortunately, I learned too late the truth about all of these things – and it was and is a train wreck!
My reasons for acting as a patient advocate are too numerous to count. I often feel my life is a cross between Alice in Wonderland, having slipped down a rabbit hole where nothing is as it seems, and Don Quixote – tilting at windmills, dreaming the impossible dream. When weary, I stand down for a time, but I will never go quietly. There is too much work to be done! Will you join me in efforts to create a safer, more just healthcare system?
I can hear my father’s voice asking, “How do you spell your last name? That’s right! Now what are you going to do about it?”
