East Coast Earthquake Update; Then, Concerns Over Hip Replacements
http://thedianerehmshow.org/shows/2011-08-24/east-coast-earthquake-update-then-concerns-over-hip-replacements
People from Vermont to South Carolina felt yesterday afternoon’s 5.8 magnitude earthquake. We look briefly at what caused the seismic event … then we turn to the ongoing problems with metal hip replacements. Since January, the Food and Drug Administration has received more than 5000 complaints about failed hips. For some patients, hips have broken down and released tiny metal particles into their bodies. Last year, the FDA recalled one type of metal hip and required manufacturers to study the effects on patients. A look at the growing number of complaints over hip replacements and what patients should know.
Guests
David Applegate
senior science adviser for earthquake and geologic hazards at the U.S. Geological Survey.
Barry Meier
staff reporter for The New York Times and author of "Pain Killer: A 'Wonder' Drug's Trail of Addiction and Death."
Dr. Josh Jacobs
second vice president of the American Academy of Orthopaedic Surgeons; professor and chair of the orthopaedic surgery department at Rush University Medical Center in Chicago.
Dr. Craig Thomas
orthopaedic surgeon at Rankin Orthopaedic and Sport Medicine Center.
Diana Zuckerman
president of the National Research Center for Women and Families.
Comments
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Thank you for discussing the issue of failed implanted medical devices. I have come to DC from TX for the 8/4/2009 Alliance for Justice Lobby Day for the Medical Device Safety Act, 9/24-25/2010 FDA Patient Representative Workshop, 6/9/2010 Consumers Union Activist Summit, 1/4/2011 FDA/MDUFA Consumer Group Discussion (spent $1700 of my personal funds to be denied participation after receiving a confirmed invitation). What I have learned as patient advocate for my brother, Steven Baker (MedWatch Adverse Event #5009052) is that there are legal barriers to patient participation in FDA decisions on medical devices and legal entitlements for the medical device manufacturers that conflict with personal civil rights. There is currently no effective failure "feedback loop" to the producers of failed implanted medical devices. This puts our healthcare funding and personal finances at risk while placing patients in increasingly vulnerable medical risk. If the FDA and the industry will not heed the IOM 7/29/11 recommendations to scrap the 510(k) process, Congress should revoke the FDA Charter for implanted medical devices - better the public is forewarned that there are no warranties, no objective registries, no clinical trials to support the aggressive marketing.
WELCOME to the for PROFIT 'health' 'care' of the US.
Disgraceful. Not profitable to ease suffering, care for illness, or allow death with dignity.
Although free access to the best of nation's healthcare MIGHT give me a different view. Wish we had Congress's healthcare plan. O' to be king...
We would love a system NOT driven by profit BUT rather the needs of the individual citizens.
Imagine studies NOT influenced by MONEY. Treatments based on science NOT advertizing. Suppose we grow up and realize average American will have WORSE healthcare than our armed forces(damn commisocialist system) OR other 'un'civilized nations.
Where weathly have cosmetic surgery BUT most live with diseased teeth. Where pets have more procedures than the minimum wage workers(who are replaced if ill- too many absences).
Even with 'law' to protect US, the 'profit' driven desire to increase ROI, causes great incentives to replace 'damged' veterans and civilans with healthy 'productive'(no using time off for medical) workers.
Remember when doctors spent ALL their time treating the sick and ill(and came to the sick and ill as opposed to assembly line waiting rooms(ps- great way to spread contagion)).
God save US... although no one really cares(other than those trying to rush judgement day). At least one plan is working.
Soylent Green, eating today, AND easing the healthcare concerns of the surplus population for tomorrow.
Find the right surgeon first and foremost. I am 4 year out with Biomet MOM hip resurfacing and could not be more satisfied. Recent ion studies are all normal..... titanium, cobalt, chromium. Two weeks ago I successfully hiked to the summit of Pikes Peak at 14,110 feet on the 13 mile Barr Trail. This was only possible with my new hip. I thank my surgeon and his team! I specifically sought out a metal on metal prosthesis and a highly experienced surgeon.
Does the Washington Cathedral have earthquake insurance? Jean Rhoads, Bloomington IN
Does the Washington Cathedral have earthquake insurance? Jean Rhoads, Bloomington IN
The right surgeon seems to be an important factor. I know someone that has cementless, metal on polyethylene hip replacement. It was done at Rush-Presbyterian in Chicago by Dr. Rosenberg in 1992. It functions flawlessly since then.
Hello Diane,
I have a metal - polyethylene total hip replacement that has lasted over 36 years.
It was done at New England Baptist Hospital by Dr. William D. Shea, when I was 19 years old and I am now 55 years old.
Dear Diane,
Please ask the surgeons how they receive their education about the different devices to enable them to conclude which have the most favorable risk/benefit outcome.
Thank you.
Listener from Chicago
What type of device is best for a 66 year old woman who has an auto-immune disorder which demonstrates itself through multiple alleriges and RA?
I had my hip replaced in 2008 with a metal on metal joint.
So far it is fine. The surgery went well, I went in on Monday and was home on Wednesday. Rehab also went very well. I am in my mid-60s and have done aikido, a martial art for 30 years
. The PT said that helped a lot. And I am not overweight. Also a help.
Having said all that, I have to add that I am furious about the recall. How did those joints get on the market? And why were we, the recipients, not warned about the metal shavings problem. I thought metal would be much better than plastic and so did my surgeon. Now I live with a nagging fear. Every little twinge makes me anxious. I don't want another surgery, but there is no recourse. If this hip fails, I will have to have another surgery and or possibly be a cripple for the rest of my life.
Cher Holt-Fortin
I would like to ask the panel,
Who should pay for the cost of the defective devices, the repeat surgeries?
This sounds like a case of privatized gains and socialized losses. These losses should be privatized.
I would like to ask the panel,
Who should pay for the cost of the defective devices, the repeat surgeries?
This sounds like a case of privatized gains and socialized losses. These losses should be privatized.
I am 45 years old and have bi-lateral degenerative hips. Surgeons are extremely hesitant to do any surgery because of my age and activity level [row masters competitve (non weight bearing sport) & ski instructor]. I have difficulty walking and standing, but my range of motion and function they do not want to do a replacement or resurfacing (current structure does not support). What kind of options should some one like myself have available for pain management (celebrex doesnt work)? I can only get cortisone once every 4mo.
Regarding clinical trials and results being published in peer-reviewed journals: I work in clinical research in the pharmaceutical industry which does publish results of their trials. There is no requirement, however, to publish negative outcomes. I don't know if this is true for the medical device industry.
Although longterm (15-year +) studies are expensive, I agree with Dr. Jacobs that a reasonable alterntive is a national registry for surgeons so they have real-time data. Patients need training on how to find the most knowledgable surgeon and how to determine the most favorable risk/benefit outcome of the devices used.
Hi. I just wanted to see why they are not using PEEK or other high strength plastics instead of PE. Polyethylene is not very strong.
I was given a new life with my metal on plastic hip replacements, 20 years ago. I think as patients there needs to be more education about respecting the fact that these hips are artificial. They will wear. Adjusting my lifestyle to avoid excessive stress to them has always been important to me. I am always surprised at folks who want to engage in physical activity at an intense level. I feel we need a national registry and patient education.
I was given a new life with my metal on plastic hip replacements, 20 years ago. I think as patients there needs to be more education about respecting the fact that these hips are artificial. They will wear. Adjusting my lifestyle to avoid excessive stress to them has always been important to me. I am always surprised at folks who want to engage in physical activity at an intense level. I feel we need a national registry and patient education.
In respect to the timely earthquake update, the magnitude of the temblor came two notches close to the limits of design of the North Anna nuclear power station located near the epicenter at Mineral, VA. The reactors there were built to withstand a 5.9-6.1 quake. Yet, the quake did not trip reactor shutdown automatically which should have happened like in Japan, unfortunately to no avail at the Fukushima 1 power station where three reactors experienced fuel core meltdowns.
Read more here: Read more here: http://brainmindinst.blogspot.com/2011/07/fukushima-failure-by-design.html
I understand that this was a heretofore unknown fault line. I also understand that it has now been named the "Bush Fault Line". That way, this disaster too, can be "Bush's Fault".
Diane: Thanks for the program. Love the show. As a researcher who educates engineers, scientists and MDs about designing and producing new biomaterials, there are some important takeaways that need to be reinforcement about resetting expectations.
For one, these total joint replacement procedures are all poor substitutes for the exquisite tissue they are replacing. It is remarkable that these types of devices do such an excellent job overall, and the typical lifetimes of implants is on the order of 12-15 years, and that expected lifetime hasnt changed in at least 20 years. Couple that with the facts that average age at death is a slightly rising function and we are installing these devices in younger patients and you quickly realize that the design lifetime of one implant isnt enough. There are also studies to show that we are now putting implants in a segment of the population that once liberated from pain and gait problems now start rock climbing, doing triathlons, etc. These devices were never designed to accommodate the abuse we do to our own bodies on a regular basis. Our bones and tissues are capable of regeneration and repair, these devices are as good as they are going to be on day one.
I'll upload more if I can...
So what are the options, and what of Metal on metal, as opposed to other articulating surfaces? Its really a function of what kind of deterioration you are least interested in having. The tort liability problems for metal on metal is clearly associated with implant recipients giving birth to kids birth defects. But I would also imagine that other steel-based implants would also have some ionic release as well. Titanium, not so much. These ions are found in a range of organs including the spleen, liver, etc. I guess the longer term concern is whether any of the ions are potential cell regulators leading to lesions and potential carcinomas triggered by the ions. The wear rates of polymeric articulating surfaces is higher, and will preferentially wear as compared to a metallic implant, so less ionic release from a metal/polymer implant most likely. But the linear wear rate of polymeric bearing surfaces is somewhere between 0.1 and 0.5mm/yr of use. If the particles are 1 micrometer in diameter, you are producing a lot of particles each year that go somewhere. They are ultimately identified by sentry cells as needing to be digested but polyethylene is inert, so nothing happens to it, but the rest of the surrounding tissue deteriorates, causing the implant to loosen. That is called osteolysis.
So you dont like your implant options, what can you do? Pain medications can stave off the immediate need for a while. Lose weight, try lower impact exercises that are less destructive on hip tissues. This will help lower the compressive loading and stress on your joints and on you whether you have the implant procedure or not. Competitive procedures to joint replacements are so-called joint fusions, where the joint will be fused together with a bony implant thus requiring new modes of walking as one has to swivel on the other functioning hip to articulate.
I could say more, but in the end, these engineered solutions are good, and perhaps could be better. But they are not organic, regenerative solutions, and our expectations should be appropriate. The outrage is misplaced.
My partner had a metal on metal hip replacement. Her doctor DID NOT offer her a choice. She immediately began to suffer, developed metalosis and spent an agonizing year trying to make her hip work, since the x-rays showed nothing!! She had it replaced and immediately began to feel better. It is shameful that anyone continues to use metal on metal, when there are so many failures!!Shame on your guest for continuing to use metal on metal on anyone!!
No wonder that medicare is in the shape it is.
I'm sure many of the surgical procedures are necessary. However, in a system that is "fee for service", it is not rocket science to understand why so many of these procedures are peformed. I find it rather difficult to understand why caring for people has been turned into a for profit enterprise. We, in our love for anything "Capitalistic" are guilty of fostering this system. Capitalism, in it's excesses, breeds greed as seen in our financial mess(and Socialism in it's excesses turns into Communism!)
Healthcare and education should be a national priority, as both are vital to the wellbeing of the country as a whole. There are many other areas where "for profit" industries would work well. Not so in healthcare and education. The negative results of a for profit healthcare system will take decades to rear it's ugly head. As is being seen, bit by bit.
If a system like medicare is to work, it requires the co-operation of both a
patient and healthcare provider population that is judicious in it's utilisation
of the system. Almost impossible in a "fee for service" environement.
Soon to be Medicare participants... try Yoga for overall good health!!!
Its great to hear about Francis' outcome. The longest I had ever heard about was ~30 years, a frail and very slight woman who was particularly careful going up and down steps. Francis' situation is endemic to other experiences of typical patients encountered at Shriner's Hospitals which has as one of its foci, the orthopaedic repair of children who have malformed hips. These patients often get implants at very young ages and its great to hear that the outcome was so good. Keep trucking!
Great show, Diane. I have heard from several orthopedic surgeons that a problem is looming on the horizon. It is that so many manufacturers are producing these devices and pressuring physicians at conferences, medical schools and at their offices to select their particular device. So, selection becomes almost political rather than technical. Thank you. Lee, Santa Fe, NM
The Washington Post reported that Dominion VA Power used a model to predict the likelihood of an earthquake in Virginia when applying for a permit for a third nuclear reactor at its Lake Anna complex.
http://www.washingtonpost.com/business/economy/for-central-virginias-sei...
“The rarity of big quakes was cited by Dominion Power a few years ago when it asked for a permit to build a third nuclear unit at North Anna, Va., just 10 to 20 miles from Tuesday’s epicenter. The company cited a model that said the odds of an earthquake greater than a magnitude of 5.5 in central Virginia were slim, predicting about six such quakes over the next 10,000 years.”
Dominion VA Power must have used the “Profit Model” to request a new nuclear power plant at Lake Anna. They should kiss that $10 billion rate-payer project goodbye and start investing in distributed solar, fuel cell and offshore wind without the risk of nuclear accident, radiation leaks and over-storage of toxic waste (currently 400% over design capacity).
I too had a successful hip resurfacing using the British Birmingham device that was mentioned by one of the MDs. My surgery was done by the really outstanding folks at the Hospital for Special Surgery in NY. The follow up by HSS is really extraordinary, tracking the ion issue as well as the functioning of the hip. I cannot tell you how much the hip resurfacing benefited me. Before the surgery the affected left leg was virtually useless for many activities like climbing stairs. Hip resurfacing, where appropriate, has many advantages over other types of replacements, including fewer long term restrictions on activities. The most important benefit is that unlike full hip replacement, resurfacing preserves most of the femur, and so if I ever need a second hip replacement, it will be easier for surgeons to anchor a full hip appliance. I also want to say that the comments from the author and researcher regarding recovery from hip replacement were really exaggerated. Granted it is not a picnic, but it is not "agonizing" and "debilitating" as they characterized it. I was away from work for only two weeks. And I left the hospital two days after the surgery taking nothing more than tylenol. Clearly there was a problem with the product the FDA recalled, but the Birmingham device which I have should not be lumped in with the recalled device and other metal-on-metal devices.
Diane,
Your show could have been dedicated to me today. I am a 52 year old woman who has survived three total hip replacements, all metal on metal. My first was at the age of 47. I was given a very large metal hip designed for a man to increase the likelihood of being able to teach for another 10 to 15 years. That replacement started loosening within the first 6 months. I have now had two replacements on my right side, and one on my left. My right hip still pops out slightly and I need surgery yet to correct the problem. As you may note, I am not able to teach and instead listen to your show on the way to doctor appointments.
Diane,
I just wanted to thank you for asking David Applegate about the possibility of hydraulic fracking playing a role in the earthquake. It brought tears to my eyes to know that, at last, that connection has been brought to light in the national media.
Please continue to discuss this extremely important phenomenon. It is ironic that the tragedy of Fukishima has made the natural gas industry more aggressive, which could, if this connection is real, bring about even more earthquakes around nuclear plants.
While Mr. Applegate wasn't aware of specific activity in the area of Mineral, Virginia, it seems to me that the huge Marcellus Shale in the Appalachian Basin isn't too far away.
On that same day, Colorado saw its largest earthquake in over 40 years, and its connection to fracking was more clear. Its epicenter was in Trinidad, in the Raton Basin, were the largest employer is the natural gas drilling company, Pioneer Natural Resources.
Perhaps you can point this out on Friday.
Thank you again,
Barbara Bellows-TerraNova
Salt Lake City