New Questions About The Safety Of Hip Replacements
http://thedianerehmshow.org/shows/2013-02-14/new-questions-about-safety-hip-replacements
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.
Guests
Barry Meier
staff reporter for "The New York Times" and author of "Pain Killer: A 'Wonder' Drug's Trail of Addiction and Death."
Diana Zuckerman
president of the National Research Center for Women and Families.
Dr. Henry Boucher
orthopedic surgeon at Medstar Union Memorial Hospital in Baltimore, Md.
Sarah Brown
CEO of The National Campaign to Prevent Teen and Unwanted Pregnancy and three-time hip replacement patient.
Kenneth Thorpe
professor and chair of health policy and management at Emory University Rollins School of Public Health.
Comments
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The implanted medical device industry has had 30 years to design an independent, robust registry of their products that would provide immediate post-market surveillance to protect against patient harm. Resistance and lobbying has created medical and legal purgatory for patients who are exposed to aggressive marketing and weak judicial protections. They are, in essence, guinea pigs. Barry Meier, NYT and Diana Zuckerman, National Research Center for Women and Families have carefully researched this issue and provide the public with it's first glimpse at the impact on our economy of allowing failed implants to compete with treatments/non-treatments that are safer and more effective. The patient harm is a national shame and will cripple all of us financially if this flaw is not corrected. Failed Implant Allliance blogspot is a compilation of my research.
I am currently involved in a lawsuit against DePuy for a metal-on-metal hip. I have had revision surgery substituting a ceramic-on-metal device. After the initial surgery I had severe cobalt/chromium poisoning resulting in angry red lesions over my entire body, polyarthralgia (pain in all my joints) and difficulty walking. I still have lesions over ,most of my body and my levels are beginning to decrease from 119 times the industrial standard of safety to about 60 times "acceptable", 2 years post-revision surgery. These metals are carcinogens and it's rather terrifying not knowing what to anticipate in the future.
I am currently involved in a lawsuit against DePuy for a metal-on-metal hip. I have had revision surgery substituting a ceramic-on-metal device. After the initial surgery I had severe cobalt/chromium poisoning resulting in angry red lesions over my entire body, polyarthralgia (pain in all my joints) and difficulty walking. I still have lesions over ,most of my body and my levels are beginning to decrease from 119 times the industrial standard of safety to about 60 times "acceptable", 2 years post-revision surgery. These metals are carcinogens and it's rather terrifying not knowing what to anticipate in the future.
Can your panel speak about CERAMIC implants? I had one implanted 4 years ago and haven't had any problems. My physician indicates that it should last 15 years.
I had a metal-on-metal hip for only 5 yr. before it had to be removed and I needed a second major surgery to replace it at a different medical center.
Shards of metal in the joint caused development of granulomas which cause fluid buildup as they dissolve, and reform in another month, from my understanding. Fluid in the joint expanded to form a second pocket in my groin. Symptom that brought me to the ER was a 2-mo. progression of swelling in the leg with the hip replacement from ankle, eventually to the groin--my leg looked like a sausage. I also had nerve compression so increasing pain down the inside of my thigh related to the compression of circulation in the groin.
After the replacement I researched European, Canadian and Australian meta-analyses. They had stopped using the metal on metal hips by 2005--2 yr. before the metal on metal replaced my hip. Had I lived in Canada in 2007 it would not have been possible for anyone to use such a hip prosthesis.
WHY do our doctors not read international research, rather than listening to company reps. and swallowing their line, straight from the manufacturing company?
With a single payer plan, information is collected and evaluated on outcomes of surgical procedures. Should we not be focused on why statistical information in our country is not gathered and collected on devices implanted in our bodies? It would be cheaper, as well as better for each of us, to know this information which seems to be missing in the US.
When my 85 year old mother finally gave into the idea of getting her knees replaced after the Doctor told her she could have done both knees 10 years before. She had been in pain for 10 years and became a vicodon junkie which of course her family Doc had prescribed for her. She is like a different person having both knees replaced in one year. Soon after the second knee she started complaining about her shoulder. I could not help it I thought she was trying to get her vicodon prescription back in working order. When we went to get the report about her shoulder the Doctor confirmed that her shoulder joint was "dust in the wind" substantiating for me she really was in pain . My mother had been extremely physically active and an incredibly hard worker in her younger years. They have been hesitant to do the shoulder replacement because it is a relatively new procedure. Hope the Rehm Team does a show on shoulder replacement
Bad Deja Vu. This travesty of Johnson & Johnson's closely parallels AH Robbins Dalkon Shield debacle in the 1970s.
They too were warned by doctors and their own technicians that their product would cause harm to patients, but the polyfiliment used was so much cheaper then the recommended monofiliment, that they went ahead. As a result, many 1000s of women were made gravely ill. Some died. Others, such as myself, were rendered sterile and underwent multiple surgeries (14 for me). The callous and calculating greed of these corporations is disgusting. They should be held to account.
I realize that you cannot read this whole thing on air, but I want to make the point that these types of horrendous decisions continue to take place amongst US medical/pharmaceutical corporations. What can be done!?
My doctor in Cincinnati Ohio has a registry and keeps statistics - his infection rate is less than 1%
I wonder if hip replacements can be made individualized for a specific person. Recently, I read Ping Fu's book BEND, NOT BREAK in which she discusses her company, Geo-Magic, which makes individualized devices (such as invisible braces for teeth) through the use of 3-D copying. It seems to me that with every person's anatomy being slightly different that such technology would be useful for hip replacements.
Thank you.
Linda Stephan
Birmingham, Alabama
Hi Diane,
can you ask about the prevalence of hip problems in cultures that sit cross legged on the floor?
I read that they live to old age with little problems
Barry Brolley Indianapolis
My comment is that having had 2 hip resurfacings on the same hip is that operator competence is of prime significance. The first surgery was done by a surgeon in the US
For the second one I went to Belgium to find an experienced surgeon for my particular type of surgery and for 2 years now have returned to playing hard racketball, with low metal ion levels, a huge range of movement and no pain.
Why does a hip replacement become necessary? Is pain the only or major reason? Does anyone know what the origin of that pain is?
Is there similar information about metal fragmentation of re-surfaced hips, for example I have a Birmingham Hip since 2007?
Thank you,
Charles
Sarver, PA
I had a hip replacement over ten years ago. The stem was not cemented but the bone was allowed to grow around it. Before the operation I was a serious cyclist and continued after. I cycle about 5000 miles a year, and this includes cycling the steep hillls on St John, VI. I am recovering from open heart surgery which I had last August. I am now in cardiac rehab and while listening to this program I am cycling 10 miles on my trainer. I am 85.
We live in CIncinnati, OH and my husband's hip replacement was done three and a half years ago at Good Samaritan Hospital. He received a DuPuy metal on metal total replacement and is currently having his blood tested annually for signs of trouble. We have not joined the law suit. He was given the metal on metal because he is very active on our farm and the doctor felt the metal on metal would be better for him than metal on plastic. We both attended a pre-operative information session at the hospital, my husband had physical and occupational therapy beginning the afternoon of his surgery and that continued at home for three weeks. We then continued his therapy for 8 more weeks at a therapy facility near our home. He did not drive for many weeks and I was careful to monitor the therapy exercises at home between his therapy sessions. So far, his replacement is fine, and he'd have one on his other side should it become necessary...but not a DuPuy. He has no pain.
I received my hip in 2001. I am an competitive equestrian, traveller, yoga student and enjoyer of life after a total hip arthroplasty with metal on plastic.
I also know that my surgeon and the researchers at Johns Hopkins have been studying outcomes of hip surgery since they started the group in the early 70's.
Definitely not a field of charlatans. Please emphasize this.
gprn
Great show.
I had a hip replacement last May and have had a great result at the age of 63. I have always been super active and in the words of my surgeon "destroyed the hip'. I have gone back to a very active lifestyle playing singles tennis, trail bicycling and snow skiing. However I followed the rehab to the word and was very careful for the first 5 months. I believe this is the key as it takes 4-5 months for the hip to mend. There is now no pain but my surgeon warned me that the hip might not last as long but so what. I am here for an active time not a long time!
The reports of metal shards from a degraded hip replacement begs the question of basic engineering evaluation of these designs. Galling wear in mechanical devices and machinery has been studied extensively, but apparently is a big surprise for physicians and medical device manufacturers. It appears that the industry is dominated by the need to sell overpriced, poorly designed products to an uninformed public. It's all about selection of the proper materials and then testing the device before its use.
Diane, concerning your comments on costs of medical procedures, I encourage your listeners to closely review their medical insurance statements. I have found that hospitals consistently bill outrageously high amounts and insurance pays a much smaller negotiated amount that in most cases I could easily pay myself. However, without insurance, I would be bankrupt if responsible for the original billed amount. In some cases tens of thousands of dollars billed are settled for a few hundred.
It's unfortunate this show squandered all of its time talking about the problems of existing hip replacements and ZERO about how one might make lifestyle changes to AVOID the surgery.
1. Does obesity increase the risk?
2. Are there better exercise routines?
3. What about something as simple as paying attention to posture while sitting or driving?
The show really missed big.
DIANE YOU WERE NOT ON YOUR A GAME TODAY!
I had my left hip replaced at age 63 after suffering for several months. My MD was wonderful and very informative prior to the surgery. He actually designs hip and knee devices. I left the hospital that same day and did not have to take any pain medication. This surgery was done in 2009 and I have felt wonderful every since. I do agree that they do not give you a lot of information on what or what not to do so I went right back to the Gym and my usual routine. Probably not the right thing to do. I am however very happy with the surgery. Great show.
Sharon Holloway
Osteopenia hips from arthritis and bone loss due to too many cortisone drugs for asthma as a very sick young adult. November 2010 had total R Arthroplasty with anterior approach on special table. I received StrykerABGII which was recalled four months ago. This hip has gone out January 2011 and again recently. I've never been pain free. I am planning anterior revision with BioMed prosthesis, different surgeon and different hospital. This isn't easy or fun!
DePuy, Stryker, Johnson and Johnson, and BioMed have all had recalls. FDA needs to be more diligent on testing protocols and history once prothetics are installed.
Communication is the best medicine when it comes to preparing for a joint replacement. The American Academy of Orthopaedic Surgeons (AAOS) has a valuable tip sheet for any patient to use with their orthopaedic surgeon. What questions do you need to ask your doctor? http://anationinmotion.org/wp-content/uploads/2012/02/Communications-Ins...
Joint replacement surgeries are among the most successful procedures in modern medicine, with improved pain, function and overall quality of life for about 90 percent of all patients. Read about the inspiring stories of real patients who because of their joint replacements, can live life to the fullest at www.ANationinMotion.org.
It is tragic enough to have to go through this hip nightmare.
On top of this if a medical device receives PMA (pre-marketing approval)
from the FDA, then this device is protected by the pre-emption laws.
In other words the manufacturer can hurt me, via their device and there is little I can do about it.
My video go to You Tube and type Howard Sadwin to see what such a device is responsible for doing to me: Smith & Nephew's Birmingham Hip Resurfacing Device, (metal on metal hip)
The FDA was formed to protect and ensure the quality and safety of our lives, then they also protect the manufacturer through the PMA approval process. Several politicians have attempted to get the attention of the FDA on this matter but to no avail.
Isn't this a conflict of interest ?? This law should be repealed or drastically modified to enable an individual to seek compensation for a device that has malfunctioned causing harm to 1000's of innocent patients.
Perhaps with the help of Diane's show I (we) can get these laws modified.
Respectfully
Howard Sadwin
It's indisputable that adverse health impacts have resulted from metal-on-metal hip prostheses. And it's very unfortunate for people who have suffered from those effects. But the following things should be kept in mind:
1. The majority of metal-on-metal recipients have not had adverse impacts.
2. Those patients who are suffering will obtain replacements and, likely, compensation.
3. Metal-on-metal implants are no longer being used.
The system has worked! Nothing designed and made by humans can be foolproof, but this is an instance in which we've learned, we've improved, and we've moved on. (Disclosure: I'm a recent recipient of a ceramic-on-plastic hip prosthesis, and my quality of life improved immensely as a result of the surgery.)
I am a 3x hip replacement person who started a website to help people with the DePuy hip and now over 500 patients later, there are hard facts. I had the DePuy in my right hip (dysplasia), small female, and almost lost my life as a result. I saw 14 orthopedic surgeons and no one questioned the device. I asked for a Cr/Co test but none had even heard of it then. My revision surgery was very difficult and it still hurts today. My left hip was replaced due to my genetic condition and all precautions taken by new surgeon for the new hip by Smith & Nephew. I had pain again almost immediately and for one year kept asking why. Finally, I asked my rheumatologist (I have due to metalossis from the DePuy) to order an X-Ray and as I put the disc in, I saw white lines around the stem. I took the tests to my surgeon. He told me he’s starting to have issues with this stem (and other surgeons as well). The rep told him they "changed the cleaning method on the stem" (coating) and it does not osteointegrate. The device is defective. He was anguished to tell me knowing what I had been through. The stem is a MIA SL-Plus. I have asked S & N to send a letter to every doctor who has implanted this to get in touch with their patients and ask them to come in for an X-Ray. They have yet to get back to me. The device has 12 MAUDE reports in the FDA system now but this is purely voluntary and there is no joint registry in the US so there may be thousands suffering and physicians may not have been told by their area reps. S & N just bought this orthopedic unit a few years ago to stay competitive. Bottom line - this is a business that has been allowed to run wild with virtually no regulation - many doctors get paid by the device manufacturer's, the reps are in the OR with patients, and many patients are told they are "too time-consuming". 4 hips in 4.5 years. I was so informed and yet I got another defective device because the system keeps this from the patient as long as it can.
I waited from November 2001 until December 2006 for my Hip Resurface that was performed at the Union Memorial Hospital in Baltimore, Maryland. Hip Replacement was game over for me as I am very active. This operation gave me my life back. I knew this was the option for me, and I believed that I would be active again. It has now been six years since my Hip Resurface, and I have never experienced any problems or issues with my Hip Resurface. I am thankful that I had this done, and I would do it again with no questions asked.