More than 20 states have passed so-called "Right-to-Try" laws that give terminally ill patients access to experimental drugs. What bypassing the F.D.A. could mean for clinical trials, treatment outcomes and patient safety.
The Food and Drug Administration recently issued new warnings on the safety of some hip replacements. As part of our occasional series, “Mind and Body,” Diane and her guests discuss what patients need to know about safety and cost of hip replacements.
- Diana Zuckerman president of the National Research Center for Women and Families.
- Sarah Brown CEO of The National Campaign to Prevent Teen and Unwanted Pregnancy and three-time hip replacement patient.
- Dr. Henry Boucher orthopedic surgeon at Medstar Union Memorial Hospital in Baltimore, Md.
- Kenneth Thorpe professor and chair of health policy and management at Emory University Rollins School of Public Health.
- Barry Meier staff reporter for "The New York Times" and author of "Pain Killer: A 'Wonder' Drug's Trail of Addiction and Death."
MS. DIANE REHMThanks 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 REHMJoining 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 firstname.lastname@example.org. Follow us on Facebook or send us a tweet. Good morning to all of you.
MS. DIANA ZUCKERMANGood morning, Diane.
MS. SARAH BROWNGood morning, Diane.
MR. BARRY MEIERGood morning.
REHMGood 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.
MEIERSure, 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.
MEIERThe 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?
REHMSo 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?
MEIERThat's correct, Diane.
MEIERThe first case just started.
REHM...when were these devices first used?
MEIERThe 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.
MEIERAnd 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.
REHMHelp 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.
MEIERWell, 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.
MEIERSo 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.
MEIERAnd 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.
REHMDid that metal debris cause other problems within the body?
MEIERThat 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.
MEIERBut 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.
REHMBarry 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?
ZUCKERMANTo 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.
REHMHow did these companies get around the FDA?
ZUCKERMANActually, 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...
ZUCKERMANAnother 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.
ZUCKERMANAnd 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.
REHMIsn't there also a question of exactly what the FDA found on Jan. 17 in regard to the metal shards traveling within the body?
ZUCKERMANWell, 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.
REHMDiana 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 BOUCHERWell, 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 BOUCHERThat'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 BOUCHERBy 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.
REHMSo despite these lawsuits -- and there are many -- are doctors still using these same kinds of devices?
BOUCHERI 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.
BOUCHERBut 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.
REHMDr. 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.
REHMAnd 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.
BROWNWell, 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.
BROWNAbout 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.
BROWNSo 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.
BROWNBut 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.
BROWNYou 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.
BROWNAnd 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.
REHMSarah, one question: How athletic were you and are you?
BROWNI'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.
REHMSarah 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?
ZUCKERMANThat 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...
REHMDo they tend to have more hip failures than men?
ZUCKERMANWell, 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.
ZUCKERMANSo 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.
REHMDr. 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?
BOUCHERWell, 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.
REHMBut now, surely, many of your patients now and your prospective patients have heard about these lawsuits.
REHMDoesn't that make them ask more questions?
BOUCHERSure. It's created much more time in the office with patients to explain those issues because they're frightened, because they see these lawsuits.
REHMI don't blame them.
BOUCHERWell, 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.
REHMStems? What do you mean?
BOUCHERStems 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.
REHMBarry Meier, talk about the reaction to the articles you've written about these lawsuits.
MEIERSure. 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.
MEIERBut 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.
MEIERWe 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.
REHMThat'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?
BOUCHERWell, 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.
ZUCKERMANAs 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.
REHMAnd 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 THORPEWell, good morning to you.
REHMI 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?
THORPEWell, 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.
THORPESo 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.
REHMInteresting to me...
THORPEThe other reason why they would vary is that programs like the Medicare program...
REHM...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?
THORPEWell, 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...
REHMBut does that make sense to you?
THORPEWell, 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.
REHMAnd you're listening to "The Diane Rehm Show." Sarah Brown.
BROWNWell, 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.
BROWNWe 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.
REHMBarry Meier, Dr. Thorpe talked about geographical differences. Is there apparently any difference in quality if one pays 180,000 versus 1,500?
MEIERWell, 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...
REHMWell, 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.
MEIERWell, 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.
MEIERAnd 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.
MEIERThe 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?
REHMAnd, of course, that must be a question you're asking all the time, Dr. Boucher.
BOUCHERAbsolutely, 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...
REHMDr. Henry Boucher. He is at Medstar Union Memorial Hospital in Baltimore, Md. When we come back, your questions and comments.
REHMAnd 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.
JOEGood morning, Diane. How are you doing?
REHMI'm good. Thanks.
JOEI'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.
JOEHowever, 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.
REHMWhat do you think, Dr. Boucher?
BOUCHERWell, 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?
REHMBut is it a little weakened by virtue of replacement? And do people who have these hip replacements need to take that into account?
BOUCHERAbsolutely. That doesn't mean you can't gain back to relatively normal strength afterwards, but it doesn't happen in a week or two.
REHMGo ahead, Sarah.
BROWNWell, 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.
BROWNAnd 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.
BROWNBut that's not the same as high quality, pre- and post-operative support and education.
ZUCKERMANWell, 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.
ZUCKERMANAnd 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.
ZUCKERMANFor 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?
REHMLet'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?
MEIERSure. 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.
MEIERSo, 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.
REHMExactly. All right. Let's go to Medford, Ore. Good morning, Milt.
MILTGood morning, Diane. And first of all, thank you for your wonderful show.
MILTYou do a marvelous job in informing us in the public.
MILTMy 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.
MILTThe 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.
ZUCKERMANYeah. 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?
REHMBarry, is that one of the issues that's come up in the lawsuit?
MEIERI 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?
MEIERSo 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.
REHMAll 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?
BOUCHERAbsolutely. 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.
BOUCHERAnd, 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...
REHMBut as you say it's going to put that much more of a burden on the doctor and the practice?
REHMSo how many patients have you implanted these metal-on-metal devices?
BOUCHERProbably less than a dozen.
REHMAnd have they now all been informed that these lawsuits are taking place?
BOUCHERWell, 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...
REHMBut 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.
BOUCHERI'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.
BOUCHERAnd the complications go way up so...
REHMOK. Let's go to Alexandria, Va. Good morning, Sharon.
SHARONGood morning, Diane. Thank you so much for doing this.
SHARONI 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.
SHARONAlmost 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.
REHMOh, 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?
MEIERThere 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.
MEIERThere'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.
REHMAll right. And you're listening to "The Diane Rehm Show." Dr. Boucher.
BOUCHERSo 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.
BOUCHERThere 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.
REHMAll right. And final call to Cape Cod, Mass. Hi there, Tessa.
TESSAHi. 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.
TESSAAnd 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...
REHMOK. We're almost out of time, Tessa.
TESSAOK. 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.
REHMOh, 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.
MEIERWell, 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.
REHMGood 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.
ZUCKERMANThank you, Diane.
BOUCHERThank you, Diane.
REHMAnd thanks for listening. I'm Diane Rehm.
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