It Takes a Team: A Unique Perspective About Medical Device Safety

 

Ah, the human knee: the strongest joint and one of the most vulnerable. Ask anyone with knee pain and they’ll attest to that.

I had bad knees for most of my life. In high school I ran cross country and had my first knee surgery at age 17. In the decades that followed I had several arthroscopic surgeries on each knee with the well healed scars to show for it.

In 2017, I was prescribed propranolol off-label for PTSD. Its intended use is to lower blood pressure. My doctor assured me that there have been promising results in PTSD studies. It lowered my blood pressure, alright. To the point that I fainted and lost consciousness. In the fall, I broke my right ankle and injured my left knee. I had surgery on my ankle and then I went back to address my knee.

I was 47 at the time of the last injury and I was told by one of the surgeons at OrthoCarolina that I was bone on bone but too young for a knee replacement. Ideally, a patient should be 50+. I felt really discouraged at the thought of waiting years for relief and I resigned myself to just being in pain all the time.

I get it though: artificial joints have a limited shelf life. The older you are, the less likely the new joint will need revision or replacement. Knee replacement surgery is a BIG surgery and other options should be exhausted before considering such an invasive surgery.

Recently a friend of mine, who happens to also be a Mecklenburg County Commissioner here in Charlotte, NC posted about her recent knee replacement surgery and spoke highly of her surgeon. I turned 51 in 2021 and I wanted to revisit my intervention options. My friend recommended Dr. Benjamin Wooster at OrthoCarolina.

He did a thorough exam of my knee and reviewed notes from past surgeries and saw that I had tried the conservative treatments first. It was his medical opinion that I was now a candidate for total knee replacement.

When he asked me what I do, I explained that I am a Special Government Employee (SGE) at the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH). In my role, I review adverse event reports for medical devices and make recommendations to FDA and device manufacturers about labeling, clinical trials, and post market surveillance.

I am also a 16-year patient advocate. This came about in 2006, when I was inappropriately prescribed Levaquin for a suspected sinus infection. I have suffered over 30 tendon ruptures as of this writing. I call it “accidental advocacy” and I’ve learned a lot since I had to navigate a complicated medical system and do my own research about the FDA approval process for medications and medical devices. I learned that in order to have informed consent that I need to work with my doctors and ask questions to help me weigh risk versus benefit.

When Dr. Wooster asked me if I had any questions, I told him I had many and explained why I was asking.

One of my main questions was about what device he uses most often and why. He told me that for my procedure, he would use the Stryker Triathlon for a total knee replacement. Having the name of the device and who makes it allows me to do my own research about the device, whether there have been any recalls or if a Black Box warning exists. When I asked him if he would be open to discussion if I found a device that I thought was safer, he told me he was open to that discussion.

I also wanted to know what the device is made of. Something we don’t often think about are what the components are made of. Typically, medical devices are made of metal and plastic. Most often out of titanium. What the average consumer doesn’t know- and that I learned in my advocacy and my work at FDA- is that coatings can be made of something different and patients are not often informed about what the other materials are made of. I asked this question because if I had a metal allergy, I could develop issues down the road. If you have a metal allergy, always let your surgeon know.

I have many allergies (NSAIDS, aspirin, sulfa, wound dressing adhesive, latex… to name a few). Luckily, I have no known allergies to metal.

Another question I had was whether he was “married” to a particular device. He understood that what I was really asking is whether he receives any consulting money from device companies. This was something I never would have thought of, had I not been involved in patient safety. If medical device sales reps have a particularly strong relationship with the surgeon, there could be the appearance of the surgeon having a direct financial incentive to use the device. Sometimes the surgeon has been flown someplace sunny to “learn about the device” on the manufacturer’s dime. My opinion on that: These relationships could unintentionally cloud the surgeon’s judgment, meaning you are not necessarily getting a fully objective view about what device is best for you. It is public information how much a doctor receives from the pharmaceutical industry and it is your right as a patient to know what those relationships are. It is one piece of a clear picture so you can decide what is best for you. After my visit with Dr. Wooster, I looked up how much he has received and confirmed that he was honest with me that he had no financial conflict of interest.  This reassured me that whatever device he and I landed on, that it was in my best interest and not financially motivated. This also reassured me that I had a doctor who was honest with me and that builds trust.

Dr. Wooster answered all of my questions to my satisfaction and as a team, we landed on the Stryker Triathlon for my joint replacement. I had it done on December 14, 2021.

I’m five weeks out now. I won’t lie: the recovery from total knee replacement is not an easy one. Knowing what recovery could look like is also something I consider when weighing my options.

As a patient who has been harmed by the pharmaceutical industry and as an employee of the FDA CDRH, I feel it gives me a unique perspective on how patients and their doctors can work together to make sure informed consent is achieved. Ask questions. Do research. Work with your medical team so you get the best possible care.

Does my position at FDA make me worried about my implanted medical devices? Absolutely. I’ve seen what can happen if a device fails or causes adverse events for the patient. Which brings me to my next point: Just because something is FDA approved, doesn’t make it safe. Here’s some information I have on my website about the approval process of medical devices that you may find helpful. (As a side note, I also have plates and screws in my C-spine that was implanted in 2008. It is monitored every year with an xray and I am happy to report I have never had any problems with it).

If you do have an adverse reaction to a medical device, it’s important to contact your surgeon but also to report that to the FDA. We look at reporting systems and data to decide if more post market surveillance is necessary or if there needs to be a change in labeling. I’ve also sat on FDA panels where a device is recommended for recall and unfortunately, the patient is the last to know.

An emerging technology is Unique Device Identifiers (UDI). UDI’s are a unique bar code specific to materials used in your surgery. Several companies are developing ways to track the UDI’s so that if a recall is issued, a patient can be notified of that. Though adverse event reporting is voluntary, I’ve made recommendations to make it mandatory and to make it easier for anyone to report an adverse event.

Patient safety is up to all of us and it can be complicated. I find that communication is key from every perspective: the patient, their medical team, and the FDA.

It is never an easy decision to have a medical device implanted but I will say this: I had enough information from various perspectives to feel comfortable in my decision to go ahead and have an artificial joint implanted.