New Questions About The Safety Of Hip Replacements

MS. DIANE REHM

10:06:55
Thanks for joining us. I'm Diane Rehm. Every year, hundreds of thousands of people have hip replacement surgery. Artificial hip devices usually last about 15 to 20 years, but lawsuits against the maker of a once popular type of artificial hip are raising some new questions about the procedure in general. Joining me to talk about hip replacement surgery: Diana Zuckerman of the National Research Center for Women and Families, Dr. Henry Boucher, an orthopedic surgeon at Medstar Union Memorial Hospital in Baltimore, Md.

MS. DIANE REHM

10:07:37
Joining us from a studio in New York: Barry Meier of The New York Times. And Sarah Brown is also here. She'll provide a patient's perspective. And I know many of you will want to join us. Give us a call, 800-433-8850. Send us an email to drshow@wamu.org. Follow us on Facebook or send us a tweet. Good morning to all of you.

MS. DIANA ZUCKERMAN

10:08:09
Good morning, Diane.

MS. SARAH BROWN

10:08:09
Good morning, Diane.

MR. BARRY MEIER

10:08:10
Good morning.

REHM

10:08:11
Good to have you all with us. Barry Meier, I'd like to start with you. I know you've been covering the trial that's going on regarding hip implants. Give us the background.

MEIER

10:08:26
Sure, Diane. Well, first of all, this -- the trial involves a device made by a unit of Johnson & Johnson that's no longer sold, and this particular device which used metal components began failing at a significant rate soon after it was implanted into people. The day this started building up, Johnson & Johnson kept selling it nonetheless. And eventually in 2010, the company recalled the device.

MEIER

10:08:55
The big problem with it is that the metal components would shed metallic debris which could get into people's muscles, tissues, bones, and set off reactions that would destroy a tissue and actually leave some of them crippled and in a terrible state. I think the bigger issue that you pointed to in your introduction is, you know, why did this product get on to the market? And what do patients who need this procedure, which as you noted is an extremely effective procedure, what kind of information should they be armed with when they go to talk to a doctor about having a hip replacement?

REHM

10:09:39
So you've now got something like 10,000 lawsuits by patients who got one of these devices, and they're in trial now. Is that correct?

MEIER

10:09:54
That's correct, Diane.

REHM

10:09:55
And...

MEIER

10:09:56
The first case just started.

REHM

10:09:56
...when were these devices first used?

MEIER

10:10:02
The ones that were used in patients here in the United States were used in 2005. There was a predecessor device that used similar components that was sold overseas in 2002 for the first time, I believe. And by 2007, Johnson & Johnson's orthopedic unit was getting reports from its own consultants that this thing was problematic. It was failing.

MEIER

10:10:28
And they actually -- the trial now has shown that they actually started a project to redesign a component, a critical component of the device but then dropped it because they determined that the sales of the product didn't justify the cost of apparently correcting the problem.

REHM

10:10:48
Help me to understand how patients and how doctors began to first learn not just that the device was failing, but that something was going on within the patient's body to signify that something bad was happening, Barry.

MEIER

10:11:14
Well, the first sign of a problem with a hip replacement is pain. I mean, the person starts to have the type of pain that is the type of pain, in some ways, that they experienced before they need a hip replacement.

REHM

10:11:26
Sure.

MEIER

10:11:27
So they're experiencing pain in their hip joint that it's difficult for them to walk. And they come to the doctor, and they say to the doctor, hey, I just got a new hip a year or two ago. What's going on? The doctor is also puzzled because they believe this thing shouldn't be malfunctioning or the patient shouldn't have pain. That's not their intent.

MEIER

10:11:47
And so eventually some doctors began to look for reasons to try to better understand what was happening. So they would do tests like drawing fluid, you know, take a needle, and they pull out some fluid by the patient's hip. And they would see this kind of dark gray gunk. That really was the reaction of the metal debris interacting with the patients tissue and creating what essentially was a discharge.

REHM

10:12:15
Did that metal debris cause other problems within the body?

MEIER

10:12:25
That is sort of a central question that, unfortunately, there's not great evidence about one way or another. That is to say, are these local problems, local to the hip? And they can be quite significant because they can damage tissue and bone to the point where it's difficult to implant another replacement.

MEIER

10:12:46
But you know, there are concerns that they -- may cause cancer and may cause kidney failure and may cause a host of other ills. But we really don't know the answer to that because this is the first kind of widespread experiment where, you know, hundreds of thousands of people were implanted with these devices.

REHM

10:13:05
Barry Meier, he is staff reporter for The New York Times, author of "Pain Killer: A 'Wonder' Drug's Trail of Addiction and Death." Turning to you, Diana Zuckerman, what's the FDA doing about these problems?

ZUCKERMAN

10:13:26
To start with, the FDA did not require any clinical trials, any studies of humans on these metal-on-metal hips or any hips prior to letting them be sold, so I know that's shocking.

REHM

10:13:39
It's shocking.

ZUCKERMAN

10:13:40
It's shocking.

REHM

10:13:41
How did these companies get around the FDA?

ZUCKERMAN

10:13:48
Actually, about 95 percent of all medical devices, including implanted devices, are not required to be studied in clinical trials before they were sold if they're considered similar to something else that's already for sale...

REHM

10:14:02
For example.

ZUCKERMAN

10:14:04
Another hip that had been sold prior that might have been made out of a different material, made by a different company, might have a different shape, might actually look quite different. And -- but this is true for, you know, for some cardiac devices, for many other devices, so hips are just one terrible example of a device that was considered not serious enough, not high risk enough to be required to do clinical trials until the kinds of problems that Barry just mentioned were found.

ZUCKERMAN

10:14:37
And then the FDA responded by saying, hmm, maybe we really do need studies. And so now the FDA is saying that the companies that want to continue to sell metal-on-metal hips must do studies and that any new companies coming in must do studies before they can sell their product. But this is only for metal-on-metal hips, not for all the other kinds of hips that are still being sold.

REHM

10:15:02
Isn't there also a question of exactly what the FDA found on Jan. 17 in regard to the metal shards traveling within the body?

ZUCKERMAN

10:15:17
Well, there's -- they've been requiring studies to look at these metal -- looking at the metal debris and what the risks are and, you know, as has been mentioned, there is concern about carcinogens, there is concern about neurotoxic effects. There are a lot of concerns about these. But in the meantime, these products are in people's bodies, and, you know, surgery is being done that will still have new patients getting these new products -- I mean, these older products.

REHM

10:15:48
Diana Zuckerman, she's president of the National Research Center for Women and Families. Dr. Henry Boucher, welcome. How long do artificial hips normally last?

DR. HENRY BOUCHER

10:16:05
Well, standard, we'll tell patients about 15 years. So, you know, just getting into this whole metal-on-metal hip issue a little bit more, you have to go back to the history a little bit more of total hip replacement. Some of the total hip replacements in the 1950s were metal-on-metal, and they're made out of cobalt and chromium, which is the alloy that's used in these devices. So the metal shards we're talking about are actually ion release from the wear, and clearly they can cause local problems in a percentage of patients.

DR. HENRY BOUCHER

10:16:38
That's -- I don't disagree with anything that Mr. Meier said. And there is -- actually, a silver lining to it is that it's actually made us much better at how we handle patients with a painful hip arthroplasty. And just in general, we have -- we're developing better tests for patients with pain to diagnose what's going, on soft tissue wise, around the hip replacements, so even metal-on-plastic hips can still have problems. And that's not to scare patients.

DR. HENRY BOUCHER

10:17:07
By and large, hip replacement is an excellent, long-lasting procedure that really improves the quality of their life. But there has been numerous studies throughout the past 10 to 20 years of metal-on-metal hips that were done in Europe that actually performed quite well, and I would have to assume that that's why they took off because it gave the promise that they wouldn't wear out in 15 years.

REHM

10:17:32
So despite these lawsuits -- and there are many -- are doctors still using these same kinds of devices?

BOUCHER

10:17:44
I would say no. So if -- back in 2005 to 2007, metal-on-metal hips were 30 percent of the market. They were very hot. For -- and in my arena for doing hip replacements, we really thought they would be better for patients. And I would add that not all implants are the same. We're talking about one particular device. They're manufactured differently. They behave differently -- not that you still can't have some of the same reactions with any metal-on-metal device.

BOUCHER

10:18:15
But at this point, I would say much less than -- it's maybe a percent or two who are still doing metal-on-metal. I can't think of anybody that would be with what's going on out there. And that's the difference between hip resurfacing, which is a different animal, but I would say metal-on-metal total hip replacement is no longer being done.

REHM

10:18:35
Dr. Henry Boucher. He is an orthopedic surgeon at Medstar Union Memorial Hospital in Baltimore, Md. When we come back, you'll hear from someone who's had numerous hip replacements. Stay with us.

REHM

10:20:05
And welcome back. We're talking about hip replacement surgery. More than 300,000 Americans have had hip replacement surgery, and that was last year alone. That number is growing. People do seem to have problems with hips causing great pain, leading to an inability to really put any weight whatsoever on that hip and end up having surgery, which can work fine in some cases. How about for you, Sarah Brown? You have had three hip replacement surgeries. Tell us why.

BROWN

10:20:59
Well, I had my first one, my left hip replacement, when I was 44 and had three relatively young children. And for me, it was a remarkably wonderful and successful event. I was in excruciating pain, and rather suddenly, and, I mean, almost within a day of the operation, I felt this gnawing pain go away. And I had a very good recovery and went back to a fully normal life working carpool, traveling, so forth.

BROWN

10:21:30
About eight years later, I had to have more work done on it because I was one of those people who had a plastic liner as opposed to metal-on-metal. It was metal-on-plastic. And it turned out the plastic degrades a bit to little bits and pieces, so I had what's called a revision where the plastic was taken out and a different plastic put in again with not an enormous amount of long-term data.

BROWN

10:21:54
So far, so good, though. Here I am now, 20 years out from the original. And then about 10 years ago, I had the other hip replaced. So I've had two on the left and one on the right. My experience in general has been very good. I've been one of the probably, you know, 85 to 90 percent of people who say it's made a huge difference in my life. I would've been in a wheelchair in my mid-40s with young children.

BROWN

10:22:20
But it is also true what we've been talking about today about the confusion and the fear and the misinformation. You know, we talk so much now in this era of health care reform about informed patients, how patients are supposed to learn everything and then make decisions. This is an area that, I think, is unusually difficult.

BROWN

10:22:38
You not only have cost issues -- which, I think, we'll get to later, how much does it cost -- you have to talk to people about minimally invasive versus the old way, which is much more dramatic. You can talk about hip resurfacing versus replacement. And then you can talk about the type of device. And the average payer simply doesn't have -- I could spend two weeks trying to figure this out.

REHM

10:23:03
Sure.

BROWN

10:23:04
And I'm sure I'll have to have something more done. Every, you know, few years I get the fan belt fixed. But the notion that individual people can figure this out on their own just strikes me as unreasonable. But again, I've had a great experience. I understand there are a number of people who've had terrible suffering, infection and all these issues we're talking about.

REHM

10:23:24
Sarah, one question: How athletic were you and are you?

BROWN

10:23:31
I've never been a great athlete unlike my family members. But I've always -- was very active in sort of gym things and basic aerobic training. And I've been able, still to this day, to do that. I came from the gym to this show. It hurts, but that's partly getting older now. So I have spinal problems and so forth. But a good hip replacement, which I've experienced, really does allow people to go back to quite normal life, which for me was thrilling.

REHM

10:23:58
Sarah Brown, she is CEO of the National Campaign to Prevent Teen and Unplanned Pregnancy. Do join us, 800-433-8850. Diana Zuckerman, coming back to you, this challenge that Sarah has talked about, if I were coming to a doctor like Dr. Boucher -- who has a fine reputation -- I'm suffering. I need a new hip. What am I going to know to ask him?

ZUCKERMAN

10:24:38
That is such a tough question. And to me, what I would most like patients to be able to ask and doctors to be able to answer would be as a woman, is there a particular kind of hip replacement that's better for me? Is there a certain kind of material that you think is better? One of the things that isn't talked about much is the fact that women tend to have a worse outcome with hip replacement, say...

REHM

10:25:07
Do they tend to have more hip failures than men?

ZUCKERMAN

10:25:12
Well, that's partly because they're older. So women are more likely to be patients, but they're also more likely to need revisions more quickly. And we don't know why that is. It's partly in the shape of the woman's hip. But it may partly be, for other reasons, maybe because the design is better for men and not as good for women of many hip replacements.

ZUCKERMAN

10:25:35
So the bottom line is if you have all these different kinds -- that you'll have all these different companies making all these different models of hips, wouldn't it be terrific if they were studied, some of them before they were sold -- studied in humans, but certainly, all of them afterwards so that you could say, OK, for young, athletic women, these hips tend to be a little better? For older couch potatoes, these other hips tend to be better. You know, for people who are overweight, this might better. For thin people, this might be better. We have no data at all, none of that.

REHM

10:26:11
Dr. Boucher, what do you tell you male or female patients who come in about the various types? What would seem to work best for that individual?

BOUCHER

10:26:27
Well, I try to engage them in the discussion because, just like Diana said, there's many different brands. And even within each brand, there are many different types. And it will be somewhat surgeon preference. But they should be able to explain their preference to the patient if they want to know. Some patients don't want to know. So the choice is left up to us and our best judgment of what we think will work the best.

REHM

10:26:51
But now, surely, many of your patients now and your prospective patients have heard about these lawsuits.

BOUCHER

10:27:02
Absolutely.

REHM

10:27:02
Doesn't that make them ask more questions?

BOUCHER

10:27:05
Sure. It's created much more time in the office with patients to explain those issues because they're frightened, because they see these lawsuits.

REHM

10:27:13
I don't blame them.

BOUCHER

10:27:14
Well, I don't either. And, you know, but it is something that we need to talk about. And just in general, hip replacement is still an excellent, safe procedure that really improves the quality of patients of lives. And I try to tailor what I do to the patient. So there are implants that, I think, may be better for a certain type of bone. I somewhat disagree with that we don't have studies out there. There are great long-term studies about different types of stems that are out there that work in men and women.

REHM

10:27:45
Stems? What do you mean?

BOUCHER

10:27:46
Stems is -- I'm sorry. They are the implant that goes into the femur, and that's what we're talking about. The socket is a round socket that fits into the pelvis, is really not much male, female. There is some differences in anatomy that can happen case by case. But we're really talking about the femoral implant, the part that goes in the femur.

REHM

10:28:05
Barry Meier, talk about the reaction to the articles you've written about these lawsuits.

MEIER

10:28:13
Sure. Well, I mean, I think the lawsuits and the discussion we're having today sort of addresses a broader issue as well. And that is, you know, why did surgeons like Dr. Boucher -- and I'm not saying picking on him individually -- but why did they embrace these implants without any data in hand? It's correct to say that they thought they were going to work better, and they believe based on some very preliminary data that they were going to work better.

MEIER

10:28:50
But there was really no actual practical data, so they basically took this on on a wing and a prayer. And we're seeing the results of that today. A number of companies have set up implant registries where they actually track the outcomes of patients who receive these devices. And based on those registries, they tailor their practices.

MEIER

10:29:11
We still do not do that in the United States. We are the largest consumer of these devices throughout the world. But we've sort of dragged our feet in creating the type of data that would be useful to both Dr. Boucher and to patients in determining what is the appropriate device for them to have.

REHM

10:29:35
That's really a good point. I'm just wondering, Dr. Boucher, when a patient does have problems, what kind of obligation are you under to report that problem, whether it's the shards or whether it's the hip is failing earlier than it should? Under what obligation are you to the FDA?

BOUCHER

10:30:03
Well, there is no definite obligation, but there is a website where you can go on and register a implant-related complication. So that's something that you can do. It is somewhat voluntary. Some of the companies, as they track their outcomes now, you -- you know, they would like to get their hands on the implant. But quite frankly now, the implants with any of these cases go right to the attorneys.

REHM

10:30:29
Diana Zuckerman.

ZUCKERMAN

10:30:31
As is true for just about every kind of adverse reaction, even death, reporting is voluntary on the part of the doctors. I think it's an ethical responsibility. But once the report goes to the company, the company is required to provide that report to the FDA.

REHM

10:30:48
And joining us now by phone from Atlanta, Ga., Kenneth Thorpe. He is professor of public health at Emory University. Good morning to you, sir.

PROF. KENNETH THORPE

10:31:02
Well, good morning to you.

REHM

10:31:03
I know that in addition to all these reports about faulty artificial hip devices, we've also heard lots of questions about the variation in cost of hip replacement. What do we know about that variation?

THORPE

10:31:25
Well, there's dramatic variation both in the prevalence of hip replacements -- so just the number of replacements done for 1,000 people varies fivefold throughout the country. And on the spending side, there is dramatic variation. That is, you know, we don't fully understand it, but it's in part linked to the fact that the cost of providing surgical procedures in different types of hospitals do vary dramatically.

THORPE

10:31:53
So a major academic medical center compared to a community hospital is going to have a dramatic cost structure difference. And so the cost of a hip replacement would vary dramatically.

REHM

10:32:06
Interesting to me...

THORPE

10:32:07
The other reason why they would vary is that programs like the Medicare program...

REHM

10:32:08
...that a study published in the Archives of Internal Medicine this spring found you can pay as little as $1,500 to as much as $182,000 for hip replacement surgery. How does that happen?

THORPE

10:32:30
Well, again, I think that, you know, hospitals charge different amounts in part because they have different cost structures, and in part 'cause, depending on how much competition there is in the local market, they can get away with it or not. Even in our Medicare program, Medicare pays dramatically different amounts of money for hip replacements in different hospitals as a part of public policy, so...

REHM

10:32:57
But does that make sense to you?

THORPE

10:33:00
Well, I mean, it does, in a sense. I mean, it could vary by up to 75 percent from the low cost to the high cost, but it's in part related to the fact that if you're paying for a procedure at, let's say, George Washington University versus a community hospital in rural Pennsylvania, you know, the cost of running those operations are dramatically different. And that's -- that is reflected in what Medicare and other payers pay for health care services.

REHM

10:33:27
And you're listening to "The Diane Rehm Show." Sarah Brown.

BROWN

10:33:33
Well, I think what Dr. Thorpe just said is very important. This huge range in cost, to me, though, as a consumer, just reflects what we see all the time in the U.S. health care system. This hip implant issue is tragic and important in and of itself. But the notion that there's enormous geographic variation in procedures that patients don't know much, that physicians vary in their preferences for different approaches to, you know, whatever it is -- spinal fusion, abdominal surgery, it goes on and on -- I think in some ways we've been naive.

BROWN

10:34:08
We think, well, this is all science-based. It's all very rational. The cost is reflected, and we have adequate data. I don't think, in many areas of American medicine, that's true. This one happens to be in high relief now, and I hope we understand that. But a lot of this is as confusing as we are discussing many areas.

REHM

10:34:29
Barry Meier, Dr. Thorpe talked about geographical differences. Is there apparently any difference in quality if one pays 180,000 versus 1,500?

MEIER

10:34:48
Well, maybe in the quality of the food you get when you're in the hospital, certainly not in the quality of the device. There have been studies made in Australia -- one came out not long ago -- a country that closely tracks device outcomes. And what they basically found is that, you know, newer devices, be it a new hip or a new knee, did not outperform older ones in terms of their longevity. So, you know, I think there's an important lesson to be learned from that, which is we have different incentives driving the costs of health care in this country, which are skyrocketing. We have...

REHM

10:35:29
Well, and on the incentive question, I'm wondering whether patients should regularly be asking whether there's any relationship between the doctor and the company that makes that particular medical device. Barry.

MEIER

10:35:50
Well, perhaps, yes. I mean, the patient should be most concerned with is this device going to work best for me? The doctor should be most concerned with the question of is this device going to work best for the patient? And again we come back to the question of data.

MEIER

10:36:06
And until the patient is in a position to actually scrutinize the data, to understand the data and the doctor himself or herself has the data, we're going to be kind of floating in this netherworld because, I mean, essentially, the imperative of the company is to keep iterating and producing new devices so it can justify cost increases for those devices.

MEIER

10:36:33
The imperative of the doctor is to try to find a newer, better device that's going to work for the patient. But the question is, is this new product that the doctor is being shown and marketed to by the sales rep actually going to improve outcomes for their patients?

REHM

10:36:48
And, of course, that must be a question you're asking all the time, Dr. Boucher.

BOUCHER

10:36:55
Absolutely, yeah. I'm well aware of the recent developments over the past 10 years in both hip and knee replacement. And, again, I don't disagree with what's been said. Some of the older devices have proven to be adequate for an excellent result and a long-term outcome. But with that said is the patient population for this procedure continues to get younger. And so if we take a 55-year-old who might live to 90, I can't guarantee them that their implant is going to last forever. So...

REHM

10:37:27
Dr. Henry Boucher. He is at Medstar Union Memorial Hospital in Baltimore, Md. When we come back, your questions and comments.

REHM

10:40:05
And welcome back. It's time to open the phones for your questions, 800-433-8850, first, to Louisville, Ky. Good morning, Joe. You're on the air.

JOE

10:40:19
Good morning, Diane. How are you doing?

REHM

10:40:20
I'm good. Thanks.

JOE

10:40:23
I've actually had my hip replaced three times. I would like to say that I basically blame myself for this. And the comment that I have are to the listeners out there that are thinking about getting their hip replaced. I'm in my late 50s. I've been very active in my life. I had a tremendous surgeon that put in a new hip for me. And I tell you, three days later, I felt like I was on top of the world. I just could not believe, you know, the remarkable recovery I had.

JOE

10:40:59
However, 28 days later, I fell off my front porch swing and fractured my femur right below the stem. So they had to go back in and put in a longer stem. And that seemed to solve the problem. But then the stem broke, and so I've had that replaced. But my comment is to those people that are active and had this done. Even though the procedure goes extremely well and they feel great later, they have to understand that it is a major surgery and that the femur has been drilled into, and they really need to take care of themselves for a while.

REHM

10:41:46
What do you think, Dr. Boucher?

BOUCHER

10:41:48
Well, I think that's exactly right. It is a major surgery. And patients come in. They want minimally-invasive surgery. They want to be healed in a week or two. They want to be back to work. They want to cycle. They want to play tennis. And it's difficult to slow them down because they do feel -- some of them feel very well within a short period of time. And so you do have to understand that you have to take that. It takes six weeks for bone to heal. It has to heal with the implant, you know?

REHM

10:42:17
But is it a little weakened by virtue of replacement? And do people who have these hip replacements need to take that into account?

BOUCHER

10:42:33
Absolutely. That doesn't mean you can't gain back to relatively normal strength afterwards, but it doesn't happen in a week or two.

REHM

10:42:41
Go ahead, Sarah.

BROWN

10:42:42
Well, I think this highlights another problem of the medical care system -- the hips being just one example -- which is the extent of counseling both before operations and after. People do an OK job, you know, the office, and some surgeons are quite communicative. But I suspect if we could do a survey, people would say, you know, I got some information, not a whole lot.

BROWN

10:43:08
And I didn't get an enormous amount of preparation for what it was really going to be like afterwards in the physical therapy and the length of recovery. One of the reasons, of course, is nobody gets paid for long, cozy conversations with patients. And so a lot of us, you know, talk to each other, we go online.

REHM

10:43:24
Sure.

BROWN

10:43:24
But that's not the same as high quality, pre- and post-operative support and education.

REHM

10:43:30
Absolutely. Diana.

ZUCKERMAN

10:43:32
Well, I think the other issue is the lack of information. And I, you know, I can't say this enough. I've read every study that's been published on hips. And although there are studies and great registries in Europe, unfortunately, the way they do hip replacements in Europe tend to be different than here. They use cement in the hip replacement which they do not use here.

ZUCKERMAN

10:43:53
And so all the data on what works and how long it lasts in Europe is mostly useless for patients here. So if, you know, this -- the discussion isn't really, you know, is it worth it to get hip replacement? By the time people get hip replacement, it's worth it.

REHM

10:44:09
Yeah. Sure.

ZUCKERMAN

10:44:10
For the vast majority of people, they need it. But if we had scientific research on human beings -- by the way, most of the research that is given to the FDA are done in laboratories by robots. So they're moving a joint around many, many, many times, but it's not in a human body. So if we had the data to say, you know, some of these probably are better than other and some are probably better for certain kinds of people than others, wouldn't it be important to know that so that the next time Sarah gets surgery, she can get a hip that lasts longer?

REHM

10:44:43
Let's hope she doesn't. Barry Meier, has all of this and the questions raised about hips and replacement hips, has that cast light on other forms of replacement, for example, knees?

MEIER

10:45:08
Sure. I mean, you know, the essential question comes back to which design and which method of implantation works best, and that is a question that people are trying to answer all the time and trying to gather data all the time about. In Europe, actually, there is data that's relevant to -- and in Australia, to patients here because they do differentiate between different types of procedures that are done whether they use cement or not.

MEIER

10:45:46
So, you know, there is a drive to better understand this. The question then is how's that data going to be embraced and proved upon and turn to the benefit of the patient? Doctors like -- surgeons like Dr. Boucher are doing the best for their patients. They certainly have the best intentions for their patients. But what kind of data do they have beyond their own subjective experience to guide that.

REHM

10:46:13
Exactly. All right. Let's go to Medford, Ore. Good morning, Milt.

MILT

10:46:20
Good morning, Diane. And first of all, thank you for your wonderful show.

REHM

10:46:23
Thanks.

MILT

10:46:23
You do a marvelous job in informing us in the public.

REHM

10:46:27
Thank you.

MILT

10:46:28
My point is not with the hip replacements but with pacemakers. Approximately 10 years ago or so, I had a pacemaker put in because of atrial fib problems. I was having a lot of difficulty with it. And about four years later, one on a routine examination by the factory rep, he was having problems adjusting it so he called his company. The company told him that there had been a recall on this pacemaker because of electrical short about a year earlier, and they have notified the cardiologist.

MILT

10:47:03
The cardiologist, while I sat in the office, checked the records, and they could not find any notification of it, which is fine. And I said, why wasn't I notified as the patient? It's my heart and my life that will be extinguished if the thing fails completely. And they said there's no requirement by the FDA to do that. They're only required to notify the doctor, and the doctor is supposed to notify the patient.

REHM

10:47:26
Diana.

ZUCKERMAN

10:47:27
Yeah. You can -- you know, if your toaster goes bad, you'll get a recall notice. If your hip goes bad or your pacemaker goes bad, the doctor will get it. What if the doctor died? What if the doctor retired? Or what if the doctor just isn't very well organized, or you moved, and they don't know where you are?

REHM

10:47:44
Barry, is that one of the issues that's come up in the lawsuit?

MEIER

10:47:51
I don't think it's come up in the lawsuit per se, but the broader issue, as Diana Zuckerman pointed out, is pervasive throughout the use of these devices. That is to say, who should be the point of contact if there is a problem? Should it be the doctor who can sort of explain the situation to the patient? Or should it be a letter that the patient gets and, you know, maybe freaks out when they get it and doesn't really know what to do?

MEIER

10:48:19
So it's sort of a complicated issue. I didn't know what happened in the caller's case whether there was a miscommunication between the company and the doctor or the doctor just didn't follow up on it.

REHM

10:48:32
All right. So, Dr. Boucher, have you had memoranda, notifications from the companies or from the FDA about some of these devices? And do you then immediately call on the patient who may have one of these devices already implanted?

BOUCHER

10:48:56
Absolutely. I think it's our obligation to do that and it's difficult. It puts a huge strain on your practice, especially if you have many patients that went through the procedure. I, fortunately, did not have many patients that have gone through this whole recalled implant. But I do get notifications on a regular basis from companies that a certain product of theirs has a certain type of recall.

BOUCHER

10:49:18
And, you know, I have to assess whether I've used that product in the past and who I've used it on. And sometimes that record may not exist 'cause it may be 10 years ago. So I think that there has to be another foolproof way to notify patients, but they have to be notified. And I think the best person to notify them in reality is the physician that can explain what it means because it does...

REHM

10:49:42
But as you say it's going to put that much more of a burden on the doctor and the practice?

BOUCHER

10:49:47
Absolutely.

REHM

10:49:49
So how many patients have you implanted these metal-on-metal devices?

BOUCHER

10:49:58
Probably less than a dozen.

REHM

10:50:01
And have they now all been informed that these lawsuits are taking place?

BOUCHER

10:50:08
Well, they have been entered into a database from -- you know, they are instructed on what to do. And they go to the website, and they are contact -- they made contact with the company. And my obligation is to let them know what's going on and to follow them and do the proper testing on them to see if there's truly a problem that needs to be addressed because...

REHM

10:50:32
But suppose they say, considering the risk that has been shown by these hundreds of thousands people who are having difficulty, I want you to remove this and replace it.

BOUCHER

10:50:50
I'm not convinced that's the best path because I think some of these implants will function fine, and I think we have to provide objective evidence that there truly is a problem. So I think the patient has to be worked up with all the tests that we've had or that we have now. And like I said, it's helped us to become better diagnosticians for painful arthroplasties in general, and then we have to make a decision. But a revision surgery is not a benign surgery. It's a big deal.

REHM

10:51:20
Sure.

BOUCHER

10:51:21
And the complications go way up so...

REHM

10:51:23
OK. Let's go to Alexandria, Va. Good morning, Sharon.

SHARON

10:51:29
Good morning, Diane. Thank you so much for doing this.

REHM

10:51:32
Sure.

SHARON

10:51:32
I had my original left-hip implant on March the 24th, 2004. I was 58 years of age and weighed 102 pounds. I'd been in considerable pain. And about 2 1/2 to three years later, I developed a terrible rash, which eventually -- and my cobalt levels went up to 136 or higher. And my (unintelligible) white count was very elevated, and I was miserable. Finally, I had a revision surgery on Oct. 20, 2010, and they took out a mass of metal debris.

SHARON

10:52:12
Almost a year later, I had developed fluid on it, actually, about eight or nine months later. And that has been taken out once, and now I have fluid again. There was, of course, no metal testing before, and the allergist did find with a back test, the scratch test, that I was allergic to cobalt. And there was no other way to come in contact with it. My rash has become considerably better. My metal ion levels have decreased, but I'm still suffering from a great deal of pain.

REHM

10:52:48
Oh, I'm so sorry. That just sounds like a ghastly experience. Barry Meier, are we also dealing here with allergies to metal, not only fragments sort of breaking off but real allergies?

MEIER

10:53:09
There seems to be some evidence that a number of people -- a percentage of people have these allergies to metals. And it seems to be a higher rate among women than among men, I mean, the women or people that will put on jewelry that contains metal and develop a skin allergy to it. So imagine now that the source of the allergic reaction is, like, constantly inside your body, and that seems to be the source of at least some of the problem. It's actually -- there's a lot of research going on on this.

MEIER

10:53:43
There's a question about whether people should be getting skin allergy tests before they receive certain types of implants. It's sort of cloudy right now. I mean, maybe Dr. Boucher has better current data on it than I do, but it is an area of interest.

REHM

10:53:58
All right. And you're listening to "The Diane Rehm Show." Dr. Boucher.

BOUCHER

10:54:05
So it's a difficult process to diagnose somebody with an allergy so I think you can default. And if somebody says I'm allergic to nickel or I have a known metal allergy, there are implants you can just place to avoid that. For instance, you pick an all-titanium implant and a ceramic ball on the plastic. Testing has been -- to my knowledge, there's really no accurate way to test for it. You can do the skin tests, which have not been that reliable.

BOUCHER

10:54:31
There is some blood testing that can be done. So sometimes patients will -- I'll take some blood from them, send it off to a special lab, and they'll look for reactivity. But it's just like you said. It's a difficult problem to diagnose. So if anybody gives me an unusual history, I'm trying to go with the most hypoallergenic hip I can.

REHM

10:54:49
All right. And final call to Cape Cod, Mass. Hi there, Tessa.

TESSA

10:54:55
Hi. I called because I just want to let people know, in my case, I had no pain. I had a lump in my groin about a year -- at the time I got the metal-on-metal hip, it felt great for about six months, nine months. And then I got a lump in my groin. It just kept getting bigger. And I was doing pilates at the time, and my hip started clunking a little bit. But -- so I went to my doctor, and he said my hip was perfect. He took an X-ray. He said everything was perfect, sent me off so that I could do PT.

TESSA

10:55:30
And I said, well, what about this lump in my groin? And he wasn't concerned. So I just kind of continued on with my life. Another point, it got larger, and I went to my doctor. And I was diagnosed with bursitis after a CAT scan. And then I was playing tennis with a girlfriend, and I was starting to lose -- I was doing power yoga, but I was starting to kind of...

REHM

10:55:53
OK. We're almost out of time, Tessa.

TESSA

10:55:56
OK. I'm sorry. But -- so eventually, she said, well, have you been looking at these articles in The New York Times? And, you know, long story short, I saw that that was me. And it turned out I had massive damage, deterioration of muscle. And the lump was so big that it was pressing up against my nerve, so that's why I couldn't feel any pain.

REHM

10:56:15
Oh, Tessa, I'm so sorry. And I hope that by now that is going to be taken care of. Barry Meier, you can see how useful your articles have been. I thank you for those and wonder what last words you might say to people who are considering hip replacements.

MEIER

10:56:42
Well, the first thing I say is what I say to friends, which is, don't hesitate to do it if you need it. The second thing I would say is, educate yourself. Read whatever you can about the outcomes and performance of devices and have a informed discussion with your doctor about it. If he wants to rush, go see another doctor, find a doctor who's willing to sit down with you and explain to you why he is using a particular device in you, and what's the data that he's basing that decision.

REHM

10:57:15
Good advice. Barry Meier, staff reporter for The New York Times, Sarah Brown, Dr. Henry Boucher, Diana Zuckerman, earlier, Kenneth Thorpe of Emory University. Thanks to all of you.

ZUCKERMAN

10:57:34
Thank you, Diane.

MEIER

10:57:34
Thank you.

BROWN

10:57:34
Thank you.

BOUCHER

10:57:35
Thank you, Diane.

REHM

10:57:35
And thanks for listening. I'm Diane Rehm.
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