The Data Doesn't Lie
Meet Madris Kinard, A Former FDA Analyst, Making Public Data About Medical Devices More Accessible
I want to introduce you to someone who has become a friend and colleague, helping transform the way we track medical device information. I’m so grateful for her work!
Madris Kinard is the pioneer and creative force behind Device Events, an innovative medical device surveillance and metric reporting system. Since the company’s founding in 2015, she has been transforming the way patterns of adverse events in medical device usage are identified and tracked—a process that significantly helps healthcare professionals mitigate risk and make safer, more informed healthcare decisions for their patients.
The information in her database can help healthcare organizations, medical device manufacturers, insurance companies, and others identify problem medical devices and understand the history, quantity, and severity of related adverse events to assess and mitigate associated risk.
Her work has been featured on CNBC’s Power Lunch and CNN, and in The New York Times, JAMA Internal Medicine, Washington Post Magazine, and others. She presents to numerous FDA public workshops and industry conferences, educating healthcare audiences nationwide about the importance of medical device surveillance.
For context: The FDA considers a product to be a device, and subject to FDA regulation, if it meets the definition of a medical device per Section 201(h) of the Food, Drug, and Cosmetic Act. The agency defines an “adverse event” as any undesirable experience associated with the use of a medical product in a patient.
Each year, the FDA receives several hundred thousand medical device reports of suspected device-associated deaths, serious injuries, and malfunctions. Manufacturers are required to report to the FDA when they learn that any of their devices may have caused or contributed to a death or serious injury. They must also report to the FDA when they become aware that their device has malfunctioned.
Of course, there are loopholes and we’ll talk about that.
Q: Let’s talk about your work before we met.
Madris: I worked at the FDA from 2010-2014 and then worked for another firm for a year. I was trying to build a database that would improve upon what the FDA had for the public. I had just started building it and was looking to start my own company.
I knew a researcher that I worked with at the FDA, who was now working at Cornell, and wanted his feedback on my pilot product. I had about two years worth of data on adverse events, which are the report that come into the FDA when something goes wrong with a device. He wanted me to look up a product called Essure, and I had never heard of it. I pulled it up and found all these reports within a few seconds and he said, “My staff has been looking for this data for months.”
He thought I was on to something and suggested we work together. At that point, I was motivated to get started on the database and pull in the rest of the data. I started following the Essure case and saw an FDA public meeting that fall. I didn’t attend the meeting in person, but watched what happened on Twitter.
I saw that the patients were saying, “I don’t know why they are not talking about nickel. They are saying they don’t have any data on it.”
So right then, I pulled up my system and did a quick search typing “Essure” and “nickel.” Within a few seconds, I saw that there were 566 reports for Essure that mentioned the word nickel, and those were all manufacturer reports to the FDA. So, I knew that the manufacturer was aware of the problem.
My question at that point was when they were saying they don’t have the data, did they mean they didn’t have it on the spot to speak about it or were they saying the data didn’t exist?
I didn’t know. I had the data but I didn’t know what to do with it. I didn’t know how to help or get involved. What can I do to help all these patients who are not getting any satisfaction from this meeting that they probably waited years to attend?
I looked online and saw you were collecting patient stories, so I wrote you an email, telling you that I thought I had information that could help these patients. Within a day, you called me back! I was driving through the city when you called and I had to pull over for this call.
You knew already that the data was inadequate and that there was a lot more to the story, because you had been talking to the patients. You were visiting the East Coast and nearby at the time, and drove to my house that day. We sat down with the printed reports and looked at them together.
Q: How did you feel that day when I came over?
Madris: Having worked at the FDA, they put the fear of God into me about talking to anyone outside of the FDA. Of course, I was no longer working for them but I still felt weary. This was the first time I was using the data and I didn’t have a fully built system yet.
The data was from manufacturers’ reporting to the FDA and it was all public information, and I had a limited amount of data at that time, about 2,000 reports.
When you search the FDA database, it’s very difficult, especially with a product like Essure, because of their search technology. If you type in “Essure” as the brand name and search it, their system pulls up every report that says “pressure,” and with medical devices, pressure is a term that’s in there a lot. It can be difficult to find the reports.
My technology is more like a Google search and it looks at every word in the whole report. The FDA database only allows you to search the manufacturer or the brand name and the you have to open every report individually to read it. That gets really cumbersome.
The system I built had these key words that just pop up in yellow. You can see right away—how many are deaths, how many are injuries or malfunctions—so you can see within a few seconds, what's going on.
And I’ll never forget, you said, “Madris, this is really important and, you don't have to be afraid of them [the FDA] because this is the data that they have, and the manufacturer is the one who sent it to them.”
It was this kick in the butt that I needed to stop being afraid.
I realized this data is here, it's real, and I need to figure out how I can help these patients. And help the physicians too. The physicians were being told that this device was safe. I would say most physicians aren't going to implant something in their patients, if they seem it could harm them.
I found out later that there were 32,000 complaint reports that were never submitted from the manufacturer to the FDA. When they leave, an FDA inspector writes them up and says you need to submit these reports, and it happened twice. There were more than 16,000 reports in each inspection that were cited and they still to this day haven't made it to the FDA that I know of.
You introduced me to some folks, I started working with patient groups, and that’s how all this started.
Q: In the documentary, “The Bleeding Edge,” you talk about how consumers assume that the FDA has the data about adverse events and that they should do more to recall bad products. Can you talk more about that?
Madris: Well, they have the data but they don't have the right systems to look at it. In the case of Essure, it was hard to track because each patient didn’t have just one symptom like more bleeding, pain, hair loss, or weight gain. It was that almost all of the patients had almost all of these symptoms at once.
The FDA can’t look at it that way. They have analysts that really read these reports as they come in. It's almost like your email inbox. You open it up each day, and you read the deaths first, and then the injuries, and then the malfunctions. Then you start over the next day. Their job is to read them and move on to the next one. Over the years I think they have been trying to improve that system but really some of these analysts that I worked with wage were reading 15,000 to 20,000 reports per year.
It was overwhelming. The burnout was high because it is very depressing to read about everything these patients are going through and your agency approved this device.
One of the things that was coming up in these reports was the phrase “single instances of device migration have occurred.” When the analyst at the FDA reads that report they see single instances as rare, something that only happens a few times. Well, I typed that phrase into my database and it was coming up hundreds of times. It’s not single cases anymore. The reports used these words that would throw off the FDA analysts. Unless you have the same person reading all the reports, they won’t detect it.
We eventually met with the FDA commissioner to try to get the device recalled. One thing that helped turned the table was that I had this data that showed all of the side effects together. It wasn’t just one patient having one side effect, but these patients had so many issues going on, between five and 15 side effects. They were often disabled; they couldn’t work anymore because the pain was excruciating; and they were developing autoimmune diseases.
The commissioner commented that this is really good information, thanked me, and then looked down the table at his staff. He asked me if it was my data and I said, “No, this is FDA data.”
He said, “So, I can get this from my staff?” And they said, “No, we can’t get you the data like this.” He asked me to send it to him directly.
Just because the FDA has the data doesn’t mean they have the tools to review it in the ways that they need to.
Q: How can people report issues with a medical device?
Madris: There used to be an iPhone app but it got shut down, unfortunately.
The best way now is to go to the FDA’s website: https://www.accessdata.fda.gov/scripts/medwatch
It used to be you had to download a form that was thirteen pages with instructions and it was really brutal, but the FDA has improved it in recent years. You can report the problem online, and it’s really not too tough.
If you report a problem to the manufacturer, there’s no promise that that will actually make it to the FDA. Yes, if you want to let the manufacturer know, that’s fine, but don’t assume they're going to submit it. We're seeing that it just doesn't always happen.
You can also talk with your physician and have them report as well, as they can add lab results, etc. One of the things I learned with Essure was that the women were saying they were in pain and that they had bleeding one and off. But it’s important for a physician to help report it by having a patient put it on a scale of 1 to 10. Was the pain just after the procedure, or is it 6 months out? Those details can help.
Another reporting tip with the FDA is that once a patient gets a device removed, I always recommend they update their report, as to whether they're doing better. Be honest with them and tell them if your pain/symptoms went away when you had the device removed. It’s such great valuable information.
Speaking of medical devices, many of you asked us to talk more about breast implants, and I talked with Madris all about them too. Tune in for that convo soon!