The decision to have surgery is not one that most people in the United States take lightly, but in some cases of extreme injury, surgery is the only option. That’s the case of people, for example, who have to have a hip replacement or a shoulder replacement or a knee replacement. In a lot of these products that we have seen over the years, the failure rate is abnormally high, and that is what we’re beginning to see with a product put out by Zimmer Biomet. It is a shoulder replacement. Attorney Wes Bowden joins Ring of Fire’s Farron Cousins to discuss this topic.
To find out more about the recall and legal options, visit: Zimmer Biomet Reverse Shoulder Injuries
Transcript of the above video:
Farron: The decision to have surgery is not one that most people in the United States take lightly, but in some cases, cases of extreme injury, extreme illness, surgery is the only option for some patients. That’s the case of people, for example, who have to have a hip replacement or a shoulder replacement or a knee replacement. In a lot of these products that we have seen over the years, the failure rate is abnormally high, and that is what we’re beginning to see with a product put out by Zimmer Biomet. It is a shoulder replacement. For more on this I have attorney Wesley Bowden here. Wes, thanks for being with me today.
Wes: Thanks for having me.
Farron: I guess the first question I have for you today is this shoulder replacement, put out by Zimmer Biomet. Explain to everybody exactly what it is.
Wes: Yeah, so people who have a torn rotator cuff, something that’s just degenerated beyond repair where the doctors can go in there with a simple orthoscope and fix it, they may look at, and their doctors may recommend to them to get what’s known as a Comprehensive Reverse Shoulder. It’s a pretty drastic procedure. It’s actually just completely replacing the shoulder, the ball and socket, and actually putting a rod all the way down the arm. It’s a pretty comprehensive surgery. It basically replaces your shoulder when the one that you were born with wears out.
Farron: These products put out by Zimmer Biomet, these are metal implants, is this the case?
Wes: Yeah, that’s right. Biomet was a company that made it. They later got bought out by a company called Zimmer so now they’ve been called since the last few years Zimmer Biomet, and Biomet is no stranger to the medical device market. They’ve been making products for years and years, and what they’ve done is they’ve made this device out of cobalt chromium. That’s what they originally applied for, and they also make it sometimes out of titanium.
Based on our research and what we’ve been looking at is, it looks like there was a problem with the actual alloy, the formula they used to make this product. What they found was that for units they made between 2008 and 2011, and those would have been implanted all the way up until 2015, they found that their product was breaking at a much higher rate than that of their competitors. People that are getting this product put in, they’re finding that they’re having to have a lot more revision surgeries than their other competitors.
Farron: Any time you have to have one of these implants, whether it is on a shoulder or a hip, a knee, whatever, people do understand that the new joint, the metal joint, is never going to quite be the same as the old joint, but what they’re hoping to do is alleviate most of the pain that they’ve been having, most of the problems that they’ve been having. When you get a device that fails, you’re subjecting that person through another very long, very rigorous, very painful surgery and recovery process. Did I get that right?
Wes: Yeah, that’s right. I mean, look, a surgery is obviously the most invasive type of procedure you can have done by your doctor. These people, when they … They’re undergoing general anesthesia. They’re having rehab. They’re running the risk of infection, and sometimes we’re seeing cases now where people have infections resulting from surgery and it just has a devastating effect on their lives.
Anytime that you’re undergoing general anesthesia and you’re having a medical device put in, there are some very serious risks that are associated with that. If you have a product that’s put in, and you expect it to basically last you the rest of your life, and that product breaks, well, you’re going back through that same procedure. You’re being put under, you’re running the risk of infection, possibly death, and so the risks are a lot higher. No one wants to undergo surgery twice when we should only be undergoing it once, and that’s really what this boils down to.
Farron: Absolutely. I know a lot of the time with these medical devices like this, especially implantable medical devices, they don’t necessarily go through the same kind of EPA testing, for example, that pharmaceuticals do. In the case of these devices, these implantable devices, these shoulders, hips, knees, any kind of replacement joint, all you have to do is show that this device is similar to something that was already approved and so you get what they call this fast track approval. To me I see a lot of problem with that in general just because we’ve almost set the system up in the United States to allow faulty products to go through with no testing at all as long as they just say, ‘Yeah, but my shoulder, it’s like the other company’s shoulder, so you don’t bother testing it. Just get it out there in the hospital as fast as possible.’ I mean, that’s basically what’s happening here.
Wes: Yeah. It’s basically the “me too” application process. What it’s actually called is in the FDA, they file what’s known as a 510K form. What they’re doing is they’re saying, ‘We’re bringing to market a device that is substantially similar or the equivalent to something else that’s already out there.’ Because of that, when they file it that way, which is the right way to file it, but the way the system is set up, you make a great point, it doesn’t draw the same scrutiny as a brand new device, something that’s never been used before. When they do that, they can have a device that has a different metal structure. They can have a device that’s a slightly different size. It can be a different product, but they’re saying that it’s designed, it’s supposed to be implemented the same way as something else and therefore it doesn’t require as much scrutiny from you, FDA. It just requires your rubber stamp.
As we know, it’s no surprise to anyone, our government agencies, they’re overtaxed and they’re underfunded. This is something that is not going to fix itself. What it really becomes is a company’s responsibility to act appropriately, to test their devices, and when they see a signal, when they see that too many of these devices are failing, to do what’s right, to protect patient safety, to make sure that people know about these dangers and that they’re educated on it, and so that doctors can be educated on it too. In this case, we saw the FDA send out a notice and say, ‘Hey, this is going to be a recall,’ and they identified 35 hundred of these units that have gone out that have been implanted in people.
A lot of these people, they don’t even know. While these notices went out to doctors and physicians and hospitals, a lot of the people that we talk to on a day-to-day business, they could say, ‘Hey, we had no idea. I had no idea that all the pain and the break that I have experienced and the second surgery I had to have, I didn’t know about that until I saw you, or until I read your article, until I saw you talking about it on television.’ This is a big issue. This is a big problem for people.
Farron: Absolutely, and 35 hundred people out there with these devices in them, many don’t know that this is what they have, if they do experience additional pain that may not think it’s anything. Maybe they moved wrong. Maybe they did something. I guess the best advice would be go back to your doctor, find out which device you have in you, and then find out further what you need to do, if this could be part of the problem with the failure rate that we’re saying with the Zimmer Biomet shoulders or if maybe it’s something else.
Wes: That’s exactly right. Yeah. The first thing you want to do is go back and talk to your surgeon or to your physician that put this in and just talk to them about whatever symptoms you’re experiencing, whether it’s pain, onset of infection, lack of mobility. Those are things that you should be talking to with your surgeon or your follow-up physician. If it is a product that is subject to this recall and that has been part of the FDA scrutiny process, you should consider consulting an attorney because these are things that we feel the company should take responsibility for when they put a product out there that was unsafe compared to its competitors. They should own up to it and help people get better.
Farron: Absolutely. Wes Bowden, thanks for talking with us today. I truly appreciate it.
Wes: Thanks for having me. Take care.
