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American Morning
House Call
Aired February 20, 2004 - 09:46 ET
THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.
THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.
SOLEDAD O'BRIEN, CNN ANCHOR: Millions of Americans have implanted medical devices, from artificial knees to hip replacements to pacemakers, but if that device is defective or if it's recalled, no one's actually required to tell you if you have one. Dr. Sanjay Gupta joins us from the CNN Center with more. This is kind of shocking, isn't it, Sanjay?
DR. SANJAY GUPTA, CNN MEDICAL CORRESPONDENT: In some way it is. And I want to break it down for you. You know, implants have become a way of life. Four thousand to 5,000 implants a year are approved. You know, over the last 10 years you have had some recalls, not surprisingly. Between 1992 and 2002, over 12,000 recalls.
Let me also say that the main infraction for these recalls is usually has to do with labeling, small things like that. Labeling obviously not something that you're going to need a re-operation for, or that most patients need to concern themselves with.
But how does the process work? That's what's at issue here. Typically what happens is that a company that makes the product will voluntarily tell the FDA that there is a problem of some sort with its product, whether it's labeling or it's something more serious. The FDA will then assess the seriousness and monitor the problem.
Then the company is required to notify distributors, hospitals and doctors, but you can see there, Soledad, patients are largely left out of the loop. Why is that? Lots of reasons. We've talked to lots of doctors about this that implant on a regular basis. They say that in typical cases, it's not going to make a difference. In most cases, it's not going to make a difference to the patient, and it may cause unnecessary anxiety. Certainly if the patients want to know, there's methods to find out, but for the most part, patients aren't required to be notified, Soledad.
O'BRIEN: OK, but if you're a patient who has a hip replacement or a knee replacement and it turns out that that actually has been recalled, for whatever reason, what happens next?
GUPTA: Well, I mean, again, you know, typically there's a process by which the companies are going to tell the FDA. The FDA is going to monitor the seriousness. But why would a hip implant get recalled? Why would someone have a malfunction with a particular product? The most common reasons are the biology of a patient. For some reason a patient does not respond well to a particular product. There could have been a complication from the operation itself. But when you're talking about the devices, the actual implant itself, it's actually very rare for the devices to fail. If they happen and a re-operation is required, then what happens is that doctor is going to need to communicate back to the patient, closely monitor the patient, and determine whether or not that operation is going to be considered. But the communication really is between the patient and the doctor primarily, Soledad.
O'BRIEN: So if they don't actually have to go ahead and inform the patient, how does the patient stay on top of whatever implant they might have and make sure that it's still safe, or certainly at least hasn't been recalled?
GUPTA: Well, there's certainly ways to do that. And for example, there's a Web site which I will share with you, www.recalls.gov. That's an FDA Web site. There is also a phone number. You can read the number there on the screen.
But I think it's worth reinforcing, Soledad, that again, the vast majority, over 90 percent of the time if -- even if there's a recall, it probably shouldn't cause undue anxiety in a particular patient who has that implant, because it may not mean -- may not mean the patient needs to do anything at all. They may not need an operation or anything.
For patients, some tips, you know, what they need to do. Keep your device model number on file. When you get an implant, find out everything you can about the device, keep the number on file, stay in good contact with your hospital and your doctor, just try to find out if there's anything going on with the implant, and periodically check the manufacturer's Web site. There is going to be some information there.
But this is not a story designed to scare people with implants. They're very common, and for the most part they are very safe, Soledad.
O'BRIEN: All right, that's good news to hear. Sanjay, thanks.
TO ORDER A VIDEO OF THIS TRANSCRIPT, PLEASE CALL 800-CNN-NEWS OR USE OUR SECURE ONLINE ORDER FORM LOCATED AT www.fdch.com
Aired February 20, 2004 - 09:46 ET
THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.
SOLEDAD O'BRIEN, CNN ANCHOR: Millions of Americans have implanted medical devices, from artificial knees to hip replacements to pacemakers, but if that device is defective or if it's recalled, no one's actually required to tell you if you have one. Dr. Sanjay Gupta joins us from the CNN Center with more. This is kind of shocking, isn't it, Sanjay?
DR. SANJAY GUPTA, CNN MEDICAL CORRESPONDENT: In some way it is. And I want to break it down for you. You know, implants have become a way of life. Four thousand to 5,000 implants a year are approved. You know, over the last 10 years you have had some recalls, not surprisingly. Between 1992 and 2002, over 12,000 recalls.
Let me also say that the main infraction for these recalls is usually has to do with labeling, small things like that. Labeling obviously not something that you're going to need a re-operation for, or that most patients need to concern themselves with.
But how does the process work? That's what's at issue here. Typically what happens is that a company that makes the product will voluntarily tell the FDA that there is a problem of some sort with its product, whether it's labeling or it's something more serious. The FDA will then assess the seriousness and monitor the problem.
Then the company is required to notify distributors, hospitals and doctors, but you can see there, Soledad, patients are largely left out of the loop. Why is that? Lots of reasons. We've talked to lots of doctors about this that implant on a regular basis. They say that in typical cases, it's not going to make a difference. In most cases, it's not going to make a difference to the patient, and it may cause unnecessary anxiety. Certainly if the patients want to know, there's methods to find out, but for the most part, patients aren't required to be notified, Soledad.
O'BRIEN: OK, but if you're a patient who has a hip replacement or a knee replacement and it turns out that that actually has been recalled, for whatever reason, what happens next?
GUPTA: Well, I mean, again, you know, typically there's a process by which the companies are going to tell the FDA. The FDA is going to monitor the seriousness. But why would a hip implant get recalled? Why would someone have a malfunction with a particular product? The most common reasons are the biology of a patient. For some reason a patient does not respond well to a particular product. There could have been a complication from the operation itself. But when you're talking about the devices, the actual implant itself, it's actually very rare for the devices to fail. If they happen and a re-operation is required, then what happens is that doctor is going to need to communicate back to the patient, closely monitor the patient, and determine whether or not that operation is going to be considered. But the communication really is between the patient and the doctor primarily, Soledad.
O'BRIEN: So if they don't actually have to go ahead and inform the patient, how does the patient stay on top of whatever implant they might have and make sure that it's still safe, or certainly at least hasn't been recalled?
GUPTA: Well, there's certainly ways to do that. And for example, there's a Web site which I will share with you, www.recalls.gov. That's an FDA Web site. There is also a phone number. You can read the number there on the screen.
But I think it's worth reinforcing, Soledad, that again, the vast majority, over 90 percent of the time if -- even if there's a recall, it probably shouldn't cause undue anxiety in a particular patient who has that implant, because it may not mean -- may not mean the patient needs to do anything at all. They may not need an operation or anything.
For patients, some tips, you know, what they need to do. Keep your device model number on file. When you get an implant, find out everything you can about the device, keep the number on file, stay in good contact with your hospital and your doctor, just try to find out if there's anything going on with the implant, and periodically check the manufacturer's Web site. There is going to be some information there.
But this is not a story designed to scare people with implants. They're very common, and for the most part they are very safe, Soledad.
O'BRIEN: All right, that's good news to hear. Sanjay, thanks.
TO ORDER A VIDEO OF THIS TRANSCRIPT, PLEASE CALL 800-CNN-NEWS OR USE OUR SECURE ONLINE ORDER FORM LOCATED AT www.fdch.com
